CSP #556 - The Effectiveness of rTMS in Depressed VA Patients
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: VA Office of Research and Development

Study Protocol 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Department of Veterans Affairs Cooperative Studies Program 
(VA CSP) 
Principal Investigator: 
Jerome A. Yesavage, MD 
Director, VISN 21 MIRECC 
Professor, Department of Psychiatry, 
Stanford University School of Medicine 
VA Palo Alto Health Care System 151Y 
3801 Miranda Avenue  
Palo Alto, California 94304  
Telephone: 650-852-3287 
Fax: 650-852-3297 
Co-chairs: 
J. Kaci Fairchild, Ph.D. 
VA Palo Alto Health Care System 151Y 
3801 Miranda Avenue 
Palo Alto, CA 94304 
Telephone: 650-493-5000 ext 63432 
Fax: 650-852-3297 
Mark S. George, MD 
Ralph H. Johnson VA Medical Center 
109 Bee Street 
Charleston, SC  
Telephone: (843) 789-7316 x5275 
or 843-876-5142 
Fax: 843-792-5702 
IDE Sponsor: 
Department of Veterans Affairs Cooperative Studies Program 
Sponsor's Representative: 
Anne H. Davis-Karim, PharmD 
VA Cooperative Studies Program 
Clinical Research Pharmacy Coordinating Center 
2401 Centre Avenue SE 
Albuquerque, NM  87106-4180 
Phone:  505-248-3200 
Fax:  505-248-3205 

TABLE OF CONTENTS 
VOLUME I 
Page 
List of Abbreviations .............................................................................................................. 1 
Executive Summary  ............................................................................................................. 5 
Protocol  ................................................................................................................................ 8 
I. 
Introduction and Background  ........................................................................................ 8 
A. Importance of Treating Treatment-Resistant Major Depression (TRMD) ............ 8 
B. Overview of rTMS in TRMD ................................................................................. 8 
C. Special Considerations for Gender and Ethnic Disparities ................................ 10 
D. Physics of rTMS ................................................................................................ 11 
E. General Description of rTMS Procedure and Determination of Motor 
Threshold (MT) .................................................................................................. 12 
F. 
rTMS Safety ...................................................................................................... 14 
G. Efficacy of rTMS and Meta-analyses ................................................................. 15 
H. Overall Assessment of Effect Size and Assessment of Potential 
Clinical Impact ................................................................................................... 16 
I. 
Justification of the Need within the VA .............................................................. 17 
1.
Assessing Effect on Suicidality .............................................................. 18
2.
The Special VA Dual-Diagnoses Population ........................................... 18
3.
Economic Issues and Accessibility of Care ............................................ 19
J. 
Summary Statement of Background and Rationale ........................................... 20 
II.
Study Objectives  ......................................................................................................... 21
A. 
Primary Objective .......................................................................................... 21 
B. 
Secondary Objectives  ................................................................................... 21 

III.
Outcome Measures  ..................................................................................................... 22
A. 
Primary   ........................................................................................................ 22 
B. 
Secondary  ..................................................................................................... 22 
IV. Study Design  ............................................................................................................... 23
V. Patient Population  ....................................................................................................... 23 
A. 
Inclusion Criteria  ........................................................................................... 23 
B. 
Exclusion Criteria  .......................................................................................... 24 
VI. Methodology ................................................................................................................ 26
A. 
Recruitment  .................................................................................................. 26 
B. 
Screening Assessments  ............................................................................... 29 
C. 
Randomization to Treatment  ......................................................................... 29 
D. 
Duration of the Study  .................................................................................... 30 
E. 
Intervention Procedure .................................................................................. 31 
F. 
Treatment Regimen  ...................................................................................... 33 
G. 
Study Assessments  ...................................................................................... 37 
H. 
Adverse Events (AE) and Adverse Device Effects (ADE)  ............................. 48 
I. 
Dropouts and Follow-Up Procedures  ............................................................ 53 
J. 
Missed Visits and Study Termination  ............................................................ 54 
K. 
Follow-up Procedures for Non-Remitters and Non-Responders  ................... 54 
L. 
Protocol Violations  ........................................................................................ 54 
M. 
Participant Compensation  ............................................................................. 55 
N. 
Genetics [Section Removed] ......................................................................... 55 
VII. Data Management and Case Report Forms  ............................................................... 55
A. 
Assessments, Case Report Forms & Frequencies of Collection  ................... 55 
B. 
Data Collection and Data Entry  ..................................................................... 55 
C. 
Study Documentation and Records Retention  .............................................. 56 
D. 
Data Security Plan  ........................................................................................ 57 

VIII. Biostatistical Consideration  ......................................................................................... 58
A. 
Sample Size  .................................................................................................. 58 
B. 
Analysis Plan  ................................................................................................ 58 
C. 
Additional Analyses ....................................................................................... 59 
D. 
Assessing Size of Treatment Effect  .............................................................. 61 
E. 
Supplemental Statistical Analyses  ................................................................ 62 
F. 
Economic Analysis  ........................................................................................ 62 
IX. Quality Assurance Procedures  .................................................................................... 63
A. 
Rater Training  ............................................................................................... 63 
B. 
Good Clinical Practices  ................................................................................. 63 
X. Study Management, Monitoring and Training .............................................................. 64 
A. 
Study Management  ....................................................................................... 64 
B. 
Monitoring  ..................................................................................................... 67 
C. 
Training  ......................................................................................................... 77 
XI.
Research Results and Confidentiality  ........................................................................ 78
A. 
Confidentiality  ............................................................................................... 78 
B. 
Publication of Research Results  ................................................................... 78 
C. 
Planned Publications  .................................................................................... 80 
XII. References  .................................................................................................................. 80

 
APPENDICES 
Appendix A   Human Rights Issues and Informed Consent  ................................................. A1 
Appendix B   Budget ............................................................................................................ B1 
Appendix C   Curricula Vitae  ............................................................................................... C1 
Appendix D   Biostatistical and Research Data Processing Procedure   .............................. D1 
 
VOLUME II 
Appendix E   Research Data Forms  .................................................................................... E1 
Appendix F   Device Handling Procedures ........................................................................... F1 
Appendix G   Investigator’s Brochure (Device Information Report)  ..................................... G1 
Appendix H   List of Exclusionary Drugs .............................................................................. H1 
Appendix I   Seizures  ........................................................................................................... I1 
Appendix J   Removed 
Appendix K   rTMS Treatment Regimen  .............................................................................. K1 
Appendix L   Ethics, Belmont Report  ................................................................................... L1 
Appendix M   Health Economics and Cost Analysis  ........................................................... M1 
Appendix N   Selected Sites    .............................................................................................. N1 
Appendix O   TMS Training and Certification  ...................................................................... O1 
 

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LIST OF ABBREVIATIONS 
ACLS 
Advanced Cardiac Life Support 
ACNP 
American College of Neuropsychopharmacology 
ADE 
Adverse Device Effects 
AE 
Adverse Event 
ALP 
Alkaline Phosphatase 
ALT/SGPT 
Alanine Aminotransferase 
AST/SGOT 
Aspartate Aminotransferase 
ATHF 
Antidepressant Treatment History Form 
BCLS 
Basic Cardiac Life Support 
BDI 
Beck Depression Inventory 
BHS 
Beck Hopelessness Scale 
BOMC 
Blessed Memory Orientation Concentration Test 
BSS 
Beck Scale for Suicidal Ideation 
BUN 
Blood Urea Nitrogen 
CAPS 
Clinician Administered PTSD Scale 
CBC 
Complete Blood Count 
CBOC 
Community Based Outpatient Clinic 
CFR 
Code of Federal Regulations 
COWA 
Controlled Oral Word Association 
CPR 
Cardio Pulmonary Resuscitation 
CPRS 
Computerized Patient Record System 
CRADO 
Chief Research and Development Officer 
CRF 
Case Report Form 
CRP 
Clinical Research Pharmacist 
CSP 
Cooperative Studies Program 
CSPCC 
Cooperative Studies Program Coordinating Center 
CSPCRPCC 
Cooperative Studies Program Clinical Research  
 
Pharmacy Coordinating Center 
CSSEC 
Cooperative Studies Scientific Evaluation Committee 
C-SSRS 
Columbia – Suicide Severity Rating Scale 
CT 
Computerized Tomography  
DAST 
Drug Abuse Screening Test 

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DMC 
Data Monitoring Committee  
DSM-IV 
Diagnostic and Statistical Manual of Mental Disorders 
ECT 
Electroconvulsive Therapy 
EDC 
Electronic Data Capture 
EMG 
Electromyogram 
FDA 
Food and Drug Administration 
FWA 
Federal Wide Assurance 
GCP 
Good Clinical Practice 
GCPMG 
Good Clinical Practice Monitoring Group 
GCPSRG 
Good Clinical Practice Standards and Resource Group 
HIPAA 
Health Insurance Portability and Accountability Act 
HRC 
Human Rights Committee 
HRQL 
Health-related Quality of Life  
HRSD 
Hamilton Rating Scale for Depression 
HSS 
Human Subjects Subcommittee 
IRB 
Institutional Review Board 
ITTRS 
Interactive Touch Tone Randomization System 
JLO 
Judgment of Line Orientation 
LDH 
Lifetime Drinking History 
LDLPFC 
Left Dorsolateral Prefrontal Cortex 
LFT 
Liver Function Test 
LSC-R 
Life Stressor Checklist - revised 
MADRS 
Montgomery-Asberg Depression Rating Scale 
MAOIs 
Monoamine Oxidase Inhibitors 
MAST 
Michigan Alcoholism Screening Test 
MCS 
Mental Component Summary 
MDD 
Major Depression Disorder 
MIRECC 
Mental Illness Research, Education and Clinical  
Center 
MRI 
Magnetic Resonance Imaging 
MT 
Motor Threshold 
MUSC 
Medical University of South Carolina 
NAART 
North American Adult Reading Test 

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NIH 
National Institute of Health  
NIMH 
National Institute of Mental Health 
NP 
Nurse Practitioner 
ORO 
Office of Research Oversight 
PCC 
Pharmacy Coordinating Center 
PCL 
PTSD Checklist 
PCS 
Physical Component Summary 
PDR 
Physician’s Desk Reference 
PTSD 
Post-Traumatic Stress Disorder 
PV 
Protocol Violation 
QIDS-C 
Quick Inventory of Depressive Symptomatology  
QOL 
Quality of Life 
RAVLT 
Rey Auditory Verbal Learning Test 
RCT 
Randomized Controlled Trial 
R&D 
Research & Development 
rTMS 
Repetitive Transcranial Magnetic Stimulation 
SA 
Substance Abuse 
SACL 
Substance Abuse Checklist 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SCID-I 
Structured Clinical Interview for DSM-IV Axis I  
 
Disorders 
SDMT 
Symbol Digits Modalities Test 
SI 
Site Investigator 
SMART 
Site Monitoring, Auditing and Resource Team 
SSRI 
Selective Serotonin Reuptake Inhibitors 
STAXI-2 
State-Trait Anger Expression Inventory -2 
TBI 
Traumatic Brain Injury 
THQ 
Trauma History Questionnaire 
TLFB 
Alcohol / Drug of Choice Timeline Followback 
TMT 
Trail Making Test 
TRMD 
Treatment-Resistant Major Depression 
TSH 
Thyroid-Stimulating Hormone 

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UADE 
Unanticipated Adverse Device Effects 
ULN 
Upper Limits of Normal 
VA 
Veterans Affairs 
VR-36 
Veterans RAND 36 Item Health Survey 
VISN 
Veterans Integrated Service Network      

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VA Cooperative Study #556 
THE EFFECTIVENESS OF rTMS IN DEPRESSED VA PATIENTS 
EXECUTIVE SUMMARY 
PURPOSE:   
This study will evaluate the efficacy, safety, durability of benefits and cost-effectiveness of 
repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of Treatment-Resistant 
Major Depression (TRMD) with emphasis on the unique VA population of depressed patients 
that are commonly comorbid for substance abuse and/or Post-Traumatic Stress Disorder 
(PTSD).  
HYPOTHESES:   
Primary Hypothesis:   
Initial Remission Rate.  In VA patients with TRMD, rTMS will result in a greater remission rate 
(Hamilton Rating Scale for Depression (HRSD24) of ≤ 10) than sham rTMS at the end of acute 
treatment.   
Primary Objective:   
To assess the efficacy of rTMS in veterans with TRMD to bring about remission of TRMD.  
This 
reflects 
the 
new 
American 
College 
of 
Neuropsychopharmacology 
(ACNP) 
recommendation (Rush et al., 2006) that “remission” rather than “recovery” be considered the 
primary outcome measure in such trials since “recovery” is “highly” dependent on baseline 
severity measures. 
Secondary Hypotheses: 
1.  Sustained Remission (“Recovery”) Rate.  At the end of the 24 week post treatment follow-
up, patients who received rTMS who remitted will be more likely to continue in remission, i.e. 
show “recovery,” than patients who received sham rTMS who remitted. 

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2.
Response Rate. Active rTMS will result in a greater response rate (≥ 50% decrease in
HRSD24) than sham rTMS after treatment. 
3.
Secondary consequences of TRMD will improve with rTMS treatment, i.e. quality of life,
symptoms of PTSD and substance abuse will improve with rTMS treatment.  
4.
Moderators of Response.  Age, severity of symptoms at baseline, type of comorbidity
(PTSD, substance abuse, or both), duration of illness and prior treatment resistance may affect 
or “moderate” treatment response.   
5. Cost Offset.  TRMD patients who received active rTMS will have lower average VA costs of
care following treatment than will TRMD patients who did not receive rTMS. 
Secondary Objectives: 
1. To evaluate the durability of benefit of rTMS in treatment of TRMD (patients receiving rTMS
are more likely to remain in remission at 24 weeks post treatment than those receiving sham).  
This reflects the ACNP criteria for “recovery” (Rush et al., 2006) that requires “recovery” to be 
defined by at least 3 months of “remission”. 
2.
To evaluate the efficacy of rTMS in bringing about a significant decrease in depressive
symptoms (≥ 50% decrease in the Hamilton Rating Scale for Depression).  This is consistent 
with the ACNP criteria for “response” (Rush et al., 2006). 
3.
To determine whether depressive symptoms, suicidality, PTSD symptoms, substance
abuse, cognitive function and quality of life improve with rTMS treatment. 
4. To determine whether age, severity of symptoms at baseline, type of comorbidity, duration
of illness, and prior treatment resistance, affect or “moderate” response to rTMS. 
5. To evaluate the cost offset of rTMS in the treatment of depression in the VA Healthcare
System. 

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Design and Methods: 
Three hundred and sixty veterans diagnosed with TRMD will be enrolled at 9 VA Medical 
Centers over a three year period.  Participants will be randomized into a double blind clinical 
trial to left prefrontal rTMS treatment or to sham (control) rTMS treatment (180 participants 
each group) for up to 30 treatment sessions.  All participants will be evaluated on a wide 
variety of measures including cognitive, neurological and functional parameters.  All will meet 
DSM-IV criteria for Major Depression and all will have failed at least two prior pharmacological 
interventions as defined by the Antidepressant Treatment History Form (ATHF) (Sackeim et al. 
1990), i.e., they are TRMD patients.  Veterans with PTSD or history of substance abuse will 
not be excluded but detailed history regarding these disorders will be obtained.  Participants 
will also not be required to stop using anti-depressant medication.  The primary dependent 
measure will be remission rate (HRSD24 ≤ 10), and secondary analyses will be conducted on 
other indices.  Comparisons between the rTMS and the sham groups will be made at the end 
of the acute treatment phase to test the primary hypothesis. 

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Protocol 
I.  INTRODUCTION AND BACKGROUND 
A.  Importance of Treating Treatment-Resistant Major Depression (TRMD)  
Major Depression (MD) is prevalent in about 10% of American medical outpatients in any given 
year (Kaplan and Sadock 1996).  Among these patients, as many as 20% respond 
incompletely or not at all to successive trials of multiple classes of antidepressant and mood 
stabilization medications, and of psychotherapy (Keller et al. 1992; Thase 2004).  Thus, within 
the VA population, there are roughly 100,000 patients with Treatment-Resistant Major 
Depression (TRMD). In such cases, the general treatment strategy is usually to advance 
treatment delivery in a way that increases response rates, albeit at the expense of increased 
risks and increased side effects.  One example would be the use of monoamine oxidase 
inhibitors (MAOIs).  Another preferred treatment modality for TRMD is electroconvulsive 
therapy (ECT) (Anonymous 2002; Kaplan and Sadock 1996; Olfson et al. 1998).  However, 
despite being the most effective antidepressant in the acute setting, ECT usage is limited by 
post-treatment amnesia and confusion, the medical risks of general anesthesia, the high costs 
associated with inpatient hospitalization, general apprehension about the procedure among 
candidate patients, and some administrative impediments (Martin et al. 2003).  Such 
approaches may be reasonable for those depressed patients who are suicidal or who have the 
most severe symptoms.  However, for the majority of patients with TRMD whose symptoms 
are more moderate, the decision to escalate treatment decisions is more difficult. Thus, new 
TRMD treatments are needed, preferably without major safety concerns or side effects as 
seen with aggressive polypharmacy or ECT.  
B.  Overview of rTMS in TRMD  
rTMS is a method of delivering brain stimulation without the seizures or risks associated with 
ECT, nor the potential side effects and risks of MAOI therapy.  It may offer a viable alternative 
to ECT.  Several studies have reported response of TRMD to rTMS (Avery et al. 1999; George 
et al. 1997; Loo et al. 1999).  Systematic review and meta-analysis of the studies to date, 
which are typically of a small scale, appear to show a positive effect in TRMD (Martin et al. 
2003).  With a minimal side effect profile, and the rarity of untoward events and side-effects 

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(Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS 
are considerably less than with ECT.  Importantly, rTMS is much less expensive to administer 
than ECT (largely due to not requiring anesthesia) (Kozel et al. 2004), and rTMS produces no 
detrimental cognitive side effects (Little et al. 2000; Triggs et al. 1999).  Thus, there is the 
potential for a significant advance in care, with associated cost savings, if rTMS were to be 
shown effective in treating TRMD in VA patients.  
A major industry trial of rTMS in TRMD has just been completed.  This randomized controlled 
trial involved 301 medication-free patients with TRMD and excluded patients dual-diagnosed 
with comorbid substance abuse (past year) or PTSD.  Response and remission rates were 
significantly better in rTMS than in controls at the end of 6 weeks treatment, but results were 
smaller and not significantly better after 4 weeks treatment.  Because the 4 week outcome was 
the a priori defined primary end point, the FDA Advisory panel reviewing this study did not 
accept this result as adequate support of this new indication for rTMS.  Nonetheless, this trial 
performed the most vigorous rTMS treatment to date of any trial with a maximum of 90,000 
stimuli delivered per patient with no significant adverse reactions and good evidence for 
efficacy after the full 6 weeks of treatment.  The device used in this trial was subsequently 
approved (October, 2008) by the FDA.   
A multi-site NIH trial (OPT-TMS) was recently completed but results are not yet available.  
There was, however, a new single-site NIH study completed by Avery and associates (2006).  
This randomized controlled trial of 68 patients with TRMD excluded patients with substance 
abuse in the past two years as well as patients with PTSD.  Response and remission rates 
were significantly better in rTMS patients than in controls.  Results were obtained at the end of 
15 sessions after a total of only 24,000 stimuli delivered.  These patients showed a substantial 
clinical response with a 20% remission rate compared to 3% in sham controls.   
In summary, there is an increasing literature demonstrating that rTMS may be a safe and 
effective treatment for TRMD.  Although one device has been approved by the FDA, clearly 
there is a need for more data, and given the unmet needs of VA patients with TRMD at risk for 
suicide, the VA cannot await industry efforts to fund further study since treatment of such 
patients is a major VA priority.  Questions also remain about its applicability in VA populations 
that differ substantially from the population used in the industry and NIH trials.   

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TRMD patients typical to the VA have been excluded from both large industry and NIH studies 
and thus their relevance to VA patients may be limited.  Data analysis by health economists at 
VA Perry Point found that more than 80% of VA depressives have a dual psychiatric diagnosis. 
Thus, there is a substantial knowledge gap relevant to the VA Mental Health mission insofar as 
a large proportion of VA depressives would have been excluded from both industry and NIH 
studies.   
The proposed study is an advance and necessary for the VA because: 
It will include dual-diagnosis patients.  
It will include patients with some suicidal ideation. 
It will include patients on antidepressant medications. 
It will address some of the limitations in the industry trial by collecting main outcome measures 
after a minimum of 20 and a maximum of 30 sessions, as described in Section VI.E., rather 
than collecting all crucial data after only 4 weeks (maximum of 20 sessions) of treatment. 
Furthermore, the proposed study will use a sham rTMS procedure that will be more difficult to 
distinguish from the actual rTMS than the approach used in the industry trial.   
C.  Special Considerations for Gender and Ethnic Disparities 
A recent study examining the 12-month prevalence rates of Major Depression Disorder (MDD) 
in multiple ethnicities reported significantly different prevalence rates based on gender and 
ethnicity.  Females (Caucasian: 12.7%; Black: 7.6%; Latino: 9.9%; Asian: 5.0%) had 
consistently higher rates than men (Caucasian: 7.9%; Black: 4.0%; Latino: 5.8%; Asian: 4.1%) 
(Gavin et al., 2010).  Recent trials of rTMS using community based samples have been 
reflective of these prevalence rates. For example, the proportions of women participating in 
two recent trials of rTMS were 53% (O’Reardon, 2007) and 57% (OPT-TMS trial) respectively, 
which is in line with the consistent findings that MDD is more prevalent in women (Marcus et 
al., 2005).  Additionally, these trials also reported significantly higher amounts of Caucasians 
(both 92%) than other ethnicities (8% “other” vs. 2% African American, 3% Asian American).  
Historically, ethnic minorities have presented for treatment of depression at significantly lower 
rates than non-Latino whites.  Specifically, recent research has found that of those 

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experiencing a depressive disorder in the previous year, 63.7% of Latinos, 68.7% of Asians, 
and 58.8% of African Americans did not access mental health treatment compared to 40.2% of 
non-Latino whites (p < .001) (Alegria et al., 2009).  The lower numbers of ethnic minorities 
represented in these rTMS trials may be reflective of the fact that fewer minorities present for 
mental health treatment.  Major depressive disorder may also have a different symptom 
presentation depending on a patient’s ethnic background.  For example, research has shown 
that Hispanic cultures may present with more anxious and somatic complaints when describing 
depressive symptoms than other ethnic groups (U.S. Department of Health and Human 
Services, 2001).   
D.  Physics of rTMS  
rTMS stimulates and induces firing in cortical neurons by producing brief pulses of an intense 
magnetic field, which ultimately lead to neuronal summation and depolarization (Bohning 
2000).  An rTMS device stores electricity in large capacitors, which when discharged, 
transiently creates about 3,000 amps of current.  High-intensity, but extremely brief (2mS) 
electric power of approximately 5 million watts (5MW) is quickly switched on and off by 
thyristors, regulating the electromagnetic coil through the discharge of large capacitors. 
(Barker 1989; Barker et al. 1987; Barker et al. 1985; Bohning et al. 1997; Davey et al. 1991; 
Roth et al. 1991; Roth et al. 2002). It is these large but transient electric currents that create a 
powerful magnetic field, up to 2 Tesla, in accordance with the principles described in Maxwell’s 
equations and Faraday’s law.  Thus, the magnetic field is significantly greater than that 
associated with common permanent magnets.  The rapidly pulsing magnetic field (~30KT/s) 
then travels across the scalp and skull and induces an electric field within the aqueous 
extracellular matrix of the brain (~30V/m). The resultant transmembrane potential leads to 
summation and,  at sufficient doses, action potential (Bohning 2000).  Hence, with rTMS, there 
is no direct passage of electrical currents through the brain, as occurs in ECT. 
An rTMS magnetic field consists of pulses of only 2 ms. in length, which is of significant 
strength only directly under the rTMS coil.  For these reasons, it is accepted by most rTMS 
researchers that rTMS produces its effects solely through the production of electrical currents 
in the cortex of the brain, and secondary neuronal network augmentation.  Because magnetic 
fields induced by rTMS decline rapidly with distance from the coil, current rTMS coils are only 
able to directly electrically stimulate the superficial cortex, and are not able to produce direct 

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Figure 1.  Diagram of simulated rTMS delivery. 
(Device not necessarily that to be used in protocol.) 
electrical stimulation deep in the brain (Bohning 2000; Roth et al. 1994; Roth et al. 2002). 
Deep brain structures are influenced secondarily through the activation of cortical-subcortical 
tracts. 
E.  General Description of rTMS Procedure and Determination of Motor Threshold (MT)  
An rTMS procedure is non-invasive and no anesthesia is required. Participants are awake and 
alert as an electromagnetic coil is placed over the head (See Figure 1).  Participants typically 
notice only a loud clicking noise, and tingling sensation on the scalp.  This scalp sensation 
results from the sound wave emitted as electricity passes through the coil, and from the 
rhythmic tensing of superficial nerves and scalp muscles.  Routine rTMS is usually mildly 
uncomfortable, but in some cases, when applied over certain peripheral or cranial nerves, can 
be painful.  The TMS treatment produces a sensation on the head that most patients tolerate 
without problems. The painfulness is linked to the intensity of stimulation, which varies from 
subject to subject because doses are based on their motor threshold. Thus some patients with 
very high motor thresholds receive higher dose TMS than do other patients, and there is a 
rough correlation of painfulness with intensity. The rate of self reported discomfort is generally 
low. For example, in the recent NIH OPT-TMS trial, site discomfort was reported by 18% of the 
patients receiving active, and 10% sham, for an average of 14% reporting this. This pain only 
rarely causes patients to drop out, and the NIH trial had an 88% retention rate to completion of 
the initial phase, with only 2-3 patients listing the painfulness as the reason for stopping.  

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Another interesting comment about the painfulness is that this improves over time or goes 
away. In fact, often patients fall asleep in the second week while receiving the same treatment 
that on the first day was reported as very painful. It is not clear why this occurs. (Anderson et 
al. 2009). 
The amount of electricity passed through the coil (and hence the power of the magnetic field 
generated) necessary to induce cortical firing varies from person to person, and also from one 
brain region to the next (Stewart et al. 2001).   
To determine the necessary level of power that must be used, the establishment of a “motor 
threshold” (MT) is the most commonly employed technique (Kiers et al. 1993; Pridmore et 
al.1998).  The MT is usually defined as the minimum amount of electricity needed to produce 
movement in the contralateral thumb, when the coil is placed in the appropriate spot over the 
primary motor cortex (Pascual-Leone et al. 1993).  The MT determining method has been 
improved with the use of an electromyograph (EMG) that is easier to teach, train, and 
operationalize than the visual method. In the recently completed NIH TMS trial, 3 of 4 sites 
used the EMG method, while one site used visual movement. The TMS vendor has 
incorporated a sophisticated EMG system within the TMS device and will provide the 
necessary software. A procedure called Maximum-Likelihood Strategy using Parameter 
Estimation by Sequential Testing MLS-PEST is a mathematical algorithm that is a promising 
alternative to traditional, time-consuming methods for determining MT. Because the EMG-
PEST method is totally automated, it may prove useful in studies using MT as a quickly 
changing variable, as well as in large-scale clinical trials (Mishory et al. 2004). Dr. George’s 
Brain Stimulation Lab has developed simple algorithms to use with the EMG system that can 
make MT determination rather rapid (8 pulses) and highly reproducible, essentially reducing 
and eliminating operator error, and almost like an automatic blood pressure cuff. 
rTMS patients sit upright or slightly reclined, wear ear plugs and headphones, and may close 
their eyes and rest during a procedure.  The patient’s head and neck is fixed in place by a 
positioning pillow, while the rTMS coil is initially positioned by the administrator, and held in 
place against the scalp using a coil-holder.  Because rTMS treatment produces no significant 
cognitive or physical side effects, patients are typically treated on an outpatient basis, driving 
themselves to and from their rTMS treatment appointment, and attending to their usual daily 
activities.  

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F.  rTMS Safety 
rTMS is generally regarded as safe and without lasting side effects. There have been no 
significant cognitive (Triggs, McCoy et al. 1999; Little, Kimbrell et al. 2000), neurological 
(Nahas, DeBrux et al. 2000) or cardiovascular sequelae reported as a result of rTMS. Patients 
treated with rTMS may experience discomfort at the site of stimulation due to depolarization of 
sensory and motor neurons in the scalp under the point of stimulation.  A muscle tension 
headache may result in some patients (generally estimated at less than 10% of sessions), and 
can persist for 1-2 hours post stimulation.  These headaches are never disabling and always 
respond to acetaminophen or ibuprofen.  The primary safety concern with rTMS has been the 
risk of seizure induction.  Eight seizures have been reported secondary to rTMS (Wassermann 
1997).  These have occurred in a sample size estimated to be over several thousand rTMS 
treatment sessions.  The rTMS community has adopted and widely used the guidelines 
prescribing a safe interval between pulse trains (Chen, Gerloff et al. 1997) and the safety 
guidelines from a National Institute of Neurological Disorders and Stroke (NINDS) workshop on 
rTMS.  These guidelines were revised in 2008 and our treatment parameters will comply with 
the 2008 guidelines (Rossi et al. 2009). To our knowledge there have been two publications 
since 1997 describing events during rTMS that might be considered seizures.  Conca and 
colleagues reported a patient who experienced a ‘pseudoabsence seizure’. It is unclear if this 
was a true seizure (Conca, Konig et al. 2000).  Bernabeu and colleagues reported on a patient 
who had a seizure during rTMS.  In this case, there was a brief interstimulus interval 
(Bernabeu, Orient et al. 2004).  The risk of seizures for rTMS treatment is less than 1%. 
Immediately following an rTMS session similar to the ones proposed in this protocol, 
participants have been tested and do not show significant neurocognitive side effects. They 
are thus free to return to work or drive themselves home.  One report found evidence of short-
term hearing loss in participants who had been exposed to rTMS (Pascual-Leone, Houser et 
al. 1993). A study of single pulse rTMS in humans did not find any hearing loss (Pascual-
Leone, Cohen et al. 1992) . To our knowledge, there has been only one study of rTMS effects 
on hearing in rats (Counter, Borg et al. 1990). Further animal research is needed.   Of more 
importance to this proposal, Loo and colleagues found mild changes in auditory threshold in 
two depressed patients following a 2-4 week treatment regimen.(Loo, Sachdev et al. 2001) 
This was mild and transient, however further safety testing appears warranted. However, in 

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general, participants in rTMS studies wear earplugs or earphones to minimize potential ear 
damage.  Hearing protection will be provided to all participants in this study. 
Zwanzger and colleagues reported one patient who developed new delusions during a 13 day 
treatment course with rTMS.(Zwanzger, Ella et al. 2002).  The patient had never suffered from 
psychotic depression in prior episodes.  
The VA has long been concerned with the issue of suicide in veterans and has funded a 
special MIRECC in VISN 19 to perform research on this issue and with whom this protocol has 
been developed.  A major risk in treating seriously depressed patients is the risk of suicide.  
Even more difficult, many of these patients have a background of having made multiple 
attempts.  Thus, monitoring suicide attempts, even the so-called less serious “gestures”, is of 
paramount importance.  In the recently completed industry trial suicidal ideation as indexed by 
the HRSD Item 3 on suicidal ideation increased in 3% of sham patients over 6 weeks and did 
not increase in active rTMS patients.  The findings of increased suicidal ideation in some sham 
patients as well as the fact that the population of TRMD patients as a whole are at elevated 
risk for suicide require that certain preventive measures be taken (Section X.B.8).  Both 
suicidal ideation (Section VI.G.18) and behavior (Section VI.G.16) will be monitored.   
Finally, since the previous review a new study examined the effects of large doses of rTMS in 
young normals (Anderson et al., 2006).  As part of a study to examine the effects of rTMS on 
sleep deprivation, healthy men were exposed to 12,960 magnetic pulses a day for up to 3 days 
in one week or 38,880 magnetic pulses.  No significant side effects were produced.   
In summary, the short-term adverse events are mild discomfort at the site of stimulation, 
transient tension-type headaches on the day of stimulation, and concerns about high-
frequency hearing loss.  A risk exists for suicide in these patients, however, extensive 
precautions have been planned in collaboration with experts on suicide from the VISN 19 
MIRECC and it is felt that inclusion of such patients in this protocol is consistent with providing 
new treatment options for these difficult patients.   
G.  Efficacy of rTMS and Meta-analyses   
There have been a large number of published trials of rTMS for the treatment of depression 
(Avery 2001; Avery et al. 1999; Berman et al. 2000; Feinsod et al. 1998; Garcia-Toro et al. 

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2001; George et al. 2000; George et al. 1997; George et al. 1995; Grisaru et al. 1994; Hoflich 
et al. 1993; Janicak et al. 2002; Klein et al. 1999; Kolbinger et al. 1995; Loo et al. 1999; Nahas 
et al. 2003; Padberg et al. 2002a; Padberg et al. 2002b; Padberg et al. 1999; Szuba et al. 
2001).  Because small participant pools have been a frequent limitation, several meta-analyses 
have been conducted in order to assess the value of rTMS as a treatment for depression, each 
using different base references and statistical methods (Burt et al 2002; Holtzheimer et al. 
2001; Kozel and George 2002; Martin JLR et al. 2002; McNamara et al. 2001). In the majority 
of these trials, the participants have failed prior medication trials. Thus, the participants 
represented in the published literature are a pre-selected group of more difficult-to-treat 
patients than those seen in typical studies of new antidepressant medications. Still, the 
conclusion of each of these five published meta-analyses has been the same: daily prefrontal 
rTMS delivered over several weeks has antidepressant effects greater than that obtained with 
placebo. In the meta-analysis by Burt et al., of 23 published comparisons for controlled rTMS 
prefrontal antidepressant trials, found that rTMS had a combined effect size of 0.67, 
considered to be a moderate to large antidepressant effect (Burt et al 2002).  In a sub-analysis, 
rTMS was compared with ECT. The effect size for rTMS in these studies was greater than in 
the studies comparing rTMS to sham, which may indicate a participant selection bias. The 
authors infer that rTMS may be most effective in the patients who also satisfy clinical 
predictors for positive ECT response.  
The most rigorous meta-analysis procedure to date was conducted using the Cochrane library 
guidelines (Martin JLR et al. 2002). This stringent meta-analysis included 14 trials suitable for 
analysis and found that left prefrontal rTMS at two weeks produced significantly greater 
improvements in the Hamilton Rating Scale than did placebo (Martin JLR et al. 2002).   
To summarize, all five rTMS meta-analyses in the published literature concur that repeated 
daily prefrontal rTMS for at least two weeks has antidepressant effects greater than sham. 
H.  Overall Assessment of Effect Size and Assessment of Potential Clinical Impact   
There is a general consensus that rTMS has a clinically significant antidepressant effect.  The 
meta-analyses above have on average, an effect size of Cohen’s d of about 0.65, (moderate 
effect) that is comparable with that of contemporary antidepressant medications. In 

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randomized controlled trials of new antidepressants, for example, a small to medium effect 
size (0.31-0.40) is common (Thase 2001).  
On a clinical level, comparisons between rTMS and ECT are frequently made, since both are 
interventional procedures reserved chiefly for treatment resistant depression.  To understand 
how comparable the two procedures are, several studies have been performed in which 
patients referred for ECT have been randomized to receive either ECT or rTMS.  Grunhaus, et 
al. 2000 has reported on two cohorts of patients presenting for ECT treatment, which were 
randomized to receive either ECT or rTMS (Gershon et al. 2003; Grunhaus et al. 2000). In 
these cohorts, ECT proved to be superior to rTMS for the relief of psychotic depression; 
however, in the absence of psychotic features, the two treatments were statistically 
indistinguishable.  Janicak, et al. has reported a small series, finding nearly equal effect sizes 
in the rTMS and ECT groups, with rTMS yielding a remission rate of 46% (Janicak et al. 2002). 
None of the studies explicitly evaluated cognitive side effect differences between rTMS and 
ECT, an area that remains important for future work.  Dannon, et al. has recently reported 
similar relapse rates in the 6 months following ECT and rTMS (Dannon et al. 2002). Pridmore 
(2000) reported on the antidepressant effects of standard ECT 3 times per week versus one 
ECT per week followed by rTMS on the other four weekdays, and found that both techniques 
yielded similar rates of improvement, when the rTMS was continued through three weeks 
(Pridmore et al. 1998).  Although no detailed neuropsychological testing was performed, it is 
likely that the rTMS and ECT group had fewer cognitive side effects than the ECT-only group.   
In summary, the literature to date suggests that rTMS clinical antidepressant effects are in a 
range that is comparable with other antidepressant medications, and that the therapeutic 
effects persist as long as those that follow ECT.  A crucial, yet unanswered, question remains:  
Are the antidepressant effects of rTMS clinically significant in the veteran population?   
I.  Justification of the Need within the VA   
TRMD patients typical to the VA have been excluded from both large industry and NIH studies 
and their relevance to VA subjects is limited.   
The proposed study is an advance and necessary for the VA because: 
It will include patients with some suicidal ideation. 

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It will include typical VA dual-diagnosis TRMD patients.  
It will provide an evaluation of economic barriers and accessibility of care issues that often 
prevent effective treatment of TRMD and suicidal ideation in VA patients. 
1. Assessing Effect on Suicidality.
The VA has a special concern regarding treating potentially suicidal veterans.    The VA needs 
new and effective treatments for potentially suicidal patients now.  In the current VA 
environment, ECT is sometimes difficult to obtain and requires specialized services such as 
anesthesiology that are not available in many settings due to economic and accessibility of 
care issues.  It would, therefore, be of benefit to the VA to determine if rTMS may be a useful 
tool for the reduction of suicidal ideation in veterans since it is likely to be more available to VA 
clinicians than ECT.   
2. The Special VA Dual-Diagnoses Population.
Although the VA population is similar to the general population in many respects, there are 
important differences.  It also differs significantly from the populations that have been included 
in prior trials. 

First of all, in the national veteran population that carries a diagnosis of a depressive
disorder (N= 946,342 in 2005 outpatient file), over 80% have at least one additional
psychiatric diagnosis.  The two most common diagnoses are PTSD (39%) and
substance abuse disorder (45%).

Our patients have had military training.  For most, as a result of basic training at a
minimum, this involves a greater familiarity with firearms and how to use them in a lethal
manner.  Of all the methods of attempted suicide, using firearms is associated with the
highest lethality.

Having served in the military means that there is a greater risk of having been exposed
to combat.  Combat-related PTSD has been found to be much less responsive to
treatment with selective serotonin reuptake inhibitors (SSRI) than non combat PTSD in
civilians, which can require an adjunctive atypical antipsychotic. (Steine, Kline, and
Matloff, 2002).

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 It is important to note that 17.7% of completed suicides in the VA system have a 
comorbid diagnosis of anxiety disorder, most with PTSD (Lehmann, McCormick, 
McCracken 1995), and this is significantly more common than in the civilian population. 
Commonly new antidepressant treatments are initially tested in highly selected patients, free 
from comorbid conditions, and not taking other antidepressant medications.  Results found in 
these ‘pure’ groups may or may not translate into similar effects in actual practice settings.   
An example of findings that did not translate from the nonveteran to the veteran population is 
the lack of response of male veterans with PTSD to SSRIs.  A recent Cochrane Review 
showed that the clinical effects of SSRIs in PTSD were significantly smaller in studies 
containing veterans than in studies with relatively few veterans (Stein, Ipser & Seeday, 2006).  
The authors state that (“The finding of a difference in the reduction of symptom severity 
between trials with few war veterans versus those with many was not surprising, given the 
general characterization of the war trauma subgroup of PTSD sufferers as more treatment 
resistant than other subgroups”) (p. 11)   
Regarding depression, the over 20 randomized controlled trials to date with rTMS for 
depression have used selected groups, as do the two recent major studies by industry and the 
NIH.  However, male veterans with depression may be quite different from the “clean” subjects 
used in the industry and NIH trials.   
In sum, the typical TRMD veteran patient is not the typical patient likely to be seen in the 
ongoing rTMS trials.  Such dual or multiple diagnoses veteran patients will not be fully 
considered in the NIH and industry trials and have been associated with relatively poor 
response to SSRIs in both PTSD and MDD.  How will typical VA patients fare with rTMS?  
Even when the ongoing studies are completed, there will be no data about whether and to 
what degree rTMS will help to treat TRMD patients suffering from multiple comorbidities.  
 
3.  Economic Issues and Accessibility of Care.   
rTMS could potentially generate substantial health benefits for VA patients.  For severely 
depressed patients who do not fully respond to medication, the primary clinical alternative is 
electroconvulsive therapy (ECT).  ECT has limited availability in the VA, in part due to its high 
cost and its substantial logistical requirements.  Preliminary theoretical data suggest that there 

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is the potential for rTMS to have a significant and drastic cost advantage (Kozel et al. 2004) 
over ECT.  Moreover, it could be disseminated and delivered to both urban as well as to rural 
facilities, and in VA Hospitals as well as Community Based Outpatient Clinics (CBOCs). In 
sum, rTMS has the potential to dramatically improve access to effective depression care for a 
large number of severely mentally ill VA patients. 
However, if shown safe and effective, the budgetary cost of rTMS will likely be an important 
consideration relating to its subsequent evaluation and implementation.  rTMS is a potentially 
expensive therapeutic intervention.  The procedure itself is administered by a nurse 
practitioner or psychiatrist, and it is repeated daily over the course of several consecutive 
weeks; devices cost up to $50,000 per unit; and infrequent but potentially serious adverse 
reactions to the treatment necessitate that candidate patients undergo precautionary screening 
and testing.  A cost analysis that thoughtfully considers the budgetary and staffing implications 
of rTMS within the VA infrastructure, where resources for mental health are limited, will be 
needed to inform assessment of the net resource impacts of offering rTMS. 
Currently ECT must be provided in hospital in a Recovery Room.  rTMS may be performed in 
an outpatient setting in, for example, Community Based Outpatient Clinics (CBOCs).  Thus, 
development of rTMS in the VA could potentially allow treatment in settings far from tertiary 
care centers, such as CBOCs, and increase accessibility of this care for veterans.   
J.  Summary Statement of Background and Rationale  
Although meta-analyses suggest there is a moderate antidepressant effect of rTMS in patients 
with TRMD, the rationale for the proposed research is based on the unique needs of the VA 
population.  A randomized, double-masked, placebo-controlled study with sufficient power, 
which evaluates rTMS in real-world VA patients with TRMD and dual psychiatric diagnoses 
being treated with antidepressants, is timely and clearly warranted.  This may only be possible 
through the VA Cooperative Study Program.  Table 1, Comparison of rTMS Studies, 
summarizes the unique characteristics of the proposed study in relation to other current work 
in the Industry-sponsored and NIH trials.   

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Table 1:  Comparison of rTMS Studies 
 
PROPOSED 
VA 
CSP STUDY 
NIMH 
INDUSTRY-
SPONSORED 
SAMPLE SIZE 
360 
240 
301 
ON 
ANTIDEPRESSANT 
MEDICATIONS 
YES 
NO 
NO 
AGE 
18-70 
21-70 
18-70 
COMORBIDITIES 
INCLUDED 
EXCLUDED 
EXCLUDED 
SUICIDALITY 
ASSESSED 
NOT ASSESSED 
NOT ASSESSED 
HEALTH 
ECONOMICS 
ASSESSED 
NOT ASSESSED 
NOT ASSESSED 
AMOUNT 
OF 
TREATMENT 
20-30 SESSIONS 
15-30 SESSIONS 
20 SESSIONS 
PRIMARY 
ASSESSMENT FOR 
REMISSION 
AT 
END 
OF 
TREATMENT 
PHASE 
AT 
END 
OF 
TREATMENT 
PHASE 
AFTER 4 WEEKS 
OF TREATMENT 
II.  STUDY OBJECTIVES  
A.  Primary Objective  
To assess the efficacy of rTMS in veterans to bring about remission of TRMD. 
B.  Secondary Objectives 
1.  To evaluate the durability of benefit of rTMS in treatment of TRMD (patients 
receiving rTMS are more likely to remain in remission at 24 weeks post treatment than 
those receiving sham). 

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2.  To evaluate the efficacy of rTMS in bringing about a significant decrease in 
depressive symptoms (a ≥ 50% decrease in the Hamilton Rating Scale for Depression).   
3.  To determine whether depressive symptoms, suicidality, PTSD, substance abuse, 
cognitive function and quality of life improve with rTMS treatment. 
4.  To determine whether age, severity of symptoms at baseline, comorbidity with 
substance abuse or PTSD, duration of illness, and prior treatment resistance, predict 
differential treatment response. 
5.  To evaluate the cost effectiveness of rTMS in the treatment of depression in the VA 
Healthcare System. 
III. OUTCOME MEASURES  
A. Primary Outcome Measures   
The proportion of participants achieving remission from depression based on the Hamilton 
Rating Scale for Depression of ≤ 10 at the end of the acute treatment phase. 
B. Secondary Outcome Measures   
The selection of secondary outcome measures is based on their use in previous studies in 
major depression, where appropriate.  
1.  Depression measured by Montgomery-Asberg Depression Rating Scales (MADRS) 
2.  Suicide Ideation measured by Beck Scale for Suicide Ideation (BSS) 
3.  Depression measured by Beck Depression Inventory (BDI) 
4.  Quality of Life measured by the VR-36 
5.  Cognitive Function as measured by a neuropsychological battery  
 
 
 

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IV.  STUDY DESIGN 
Our hypotheses will be tested in a three and a half year randomized double blind clinical trial of 
rTMS in TRMD.  Three hundred and sixty participants will be recruited from 9 VA sites where 
they have been evaluated on a wide variety of measures including cognitive, neurological and 
functional parameters.  All will meet DSM-IV criteria for Major Depression and all will have at 
least two failed pharmacological interventions as defined by the ATHF (Sackeim et al. 1990), 
i.e. they are TRMD patients.  The primary dependent measure will be remission rate (HRSD24 
≤ 10) at the end of the acute treatment phase, and secondary analyses will be conducted on 
other indices.  
V.  PATIENT POPULATION 
The inclusion/exclusion criteria are designed to identify patients with TRMD who exhibit a full 
range of the manifestations of that condition.  Furthermore, the population is intended to be 
representative of the VA’s pool of patients with TRMD.   
A. Inclusion Criteria 
1.  Between 18 and 80 years of age. 
2.  Using the Structured Clinical Interview for DSM Disorders (SCID) for DSM-IV-TR 
(First et al. 2002) patients will be diagnosed MDD. 
3.  Have a HRSD24 ≥ 20 no more than 7 days prior to randomization.   
4.  Exhibit moderate level of resistance to antidepressant treatment defined, using the 
ATHF (Sackeim et al. 1990), as failure of at least two adequate medication trials. 
5.  Duration of current episode of MDD ≤ 10 years. 
6.  Ability to obtain a Motor Threshold (MT) (should be determined at the end of the 
screening process). 
7.  Currently under the care of a VA psychiatrist. 

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8. If on a psychotropic medication regimen, that regimen will be stable for at least 4
weeks prior to randomization to the study and patient will be willing to remain on a 
stable regimen during the acute treatment phase.   
9. Has an adequately stable condition and environment to enable attendance at
scheduled clinic visits. 
10. For female participants, agrees to use one of the following acceptable methods of
birth control 

Complete abstinence (not having sexual intercourse with anyone)

An oral contraceptive (birth control pills)

Norplant

Depo-Provera

A condom with spermicide

A cervical cap with spermicide

A diaphragm with spermicide

An Intrauterine device

Surgical sterilization (having your tubes tied)
11. Able to read, verbalize understanding and voluntarily sign the Informed Consent
Form prior to performance of any study-specific procedures or assessments. 
B. Exclusion Criteria  
1. Pregnant or lactating female (This is an FDA-required exclusion.  In the future, if
rTMS becomes a proven treatment for major depression, its safety in the context of 
pregnancy should be studied separately (Nahas et al. 1999). 
2. Unable to be safely withdrawn, at least two-weeks prior to treatment
commencement, from medications that substantially increase the risk of having 

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seizures.  For the purpose of this study, those medications are listed in Appendix H (for 
example, theophylline).   
3.  Have a cardiac pacemaker.  
4.  Have an implanted device (deep brain stimulation) or metal in the brain.  
5.  Have a cochlear implant. 
6.  Have a mass lesion, cerebral infarct, increased intracranial pressure, or other active 
CNS disease, including a seizure disorder.   
7.  Known current psychosis as determined by DSM-IV or SCID (axis I, psychotic 
disorder, schizophrenia) or a history of a non-mood psychotic disorder.  
8.  Known current Bipolar I disorder as determined by SCID or a History of Bipolar I 
disorder. 
9.  Current amnestic disorders, dementia, BOMC > 10, delirium, or other cognitive 
disorders. 
10.  Current substance abuse (not including caffeine or nicotine) as determined by 
positive toxicology screen, or by history via SCID, within 3 months prior to screening.  
11.  Patients with an elevated risk of seizure due to TBI.  
12.  Participation in another concurrent clinical trial.  
13.  Patients with prior exposure to rTMS.   
14.  Active current suicidal intent or plan as evidenced by a score of 4 or 5 on the 
suicidal ideation portion of the CSSRS or the endorsement of an actual attempt, 
interrupted attempt, or an aborted attempt in the past 6 months.  All patients will be 
required to establish a written safety plan involving their primary VA psychiatrist and the 
treatment team before entering the clinical trial (See Section X.B.8).  
15.  Unstable cardiac disease or recent (< 3 months previous) myocardial infarction. 
16.  Patient refuses to sign consent for participation in the study. 

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VI. METHODOLOGY
A.  Recruitment 
1.
Target:  In order to meet the target of randomizing 360 participants within three
years, the Study Chairman will select 9 potential VA sites for participation based on the 
availability of a large number of TRMD patients with relevant co-morbidities and the willingness 
and ability of the site to carry out the protocol.  Each site will be expected to randomize at least 
40 eligible patients over the three year recruitment period of the study.  The VA sites that have 
expressed an interest in participating in this study and who treat a substantial number of 
relevant TRMD patients within a 3 year period can be found in Appendix N.    
2. Methods:  The Site Investigator (SI) and the Study Coordinator (SC) (hired at each
site to work full-time on this project) will be responsible for patient recruitment.  They will work 
closely with the site clinical staff to insure that the purpose and scope of the study, including 
eligibility criteria, are fully explained at the beginning of the study. Site staff will be told who to 
contact to refer a potential study participant.  Study participants will be selected from the entire 
cohort of patients referred for outpatient or inpatient psychiatric treatment at the participating 
sites.  In consultation with the SI, the patient’s referring physician will continue to manage the 
general psychiatric care of each of the participants. The primary care physician and SI will 
work together with respect to management of the subject’s care while participating in the study. 
3. Patient Pool:  The SIs and the SCs should expect to screen in person as many as
2-3 potential patients for every eligible consenting participant and will enroll (consent) 720-800 
patients with concomitant disease at the local sites.  The Human Studies Subcommittee and/or 
IRB will review any posters or advertisements used before being posted.  It is essential to 
maintain a flow of patients for screening throughout the three year recruitment period. 
4. Recruitment Plan:  Potential participants will be recruited through a number of
methods.  These include, but are not limited to, referral by primary providers, referral by mental 
health providers, flyers posted in common areas such as canteens at VA hospitals, review of 
the VA administrative databases containing information for both outpatient and in-patient 
encounters which are housed in the Austin Information Technology Center, sending IRB 
approved messages to providers twice a year, and posting basic information about the study in 
local VA SharePoint sites. 

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a) Provider Referral:  Local study staff will work with providers at their respective   
  
medical centers to identify veterans who may be appropriate for participation in this  
  
study.  These providers will be in primary care and / or mental health clinics, residential  
  
treatment facilities, or inpatient psychiatry units.  It is the responsibility of the provider  
  
to discuss the project with the veteran to determine interest in participation.  Should the  
  
veteran be interested in learning more about the study, the provider will offer the   
  
veteran the options of either having study staff contact the veteran directly or the   
  
veteran contact the study staff.  Additionally, the provider will be given a letter and  
  
response card they can send to their veteran patients informing them about the study  
  
and offering the option either for them to contact the study staff to learn more about the  
  
study, or have the study staff contact the patient.  At no time will study staff  
 
  
contact veterans who have not expressed their desire to be contacted.  
Study staff will be mindful of the constraints of recruiting from inpatient units, given that 
those who are involuntarily hospitalized cannot give consent, and, thus are ineligible to 
participate.  However, should veterans be released and express interest in participating, 
s/he will be eligible for screening. 
Study staff will conduct a basic though highly structured eligibility screen using the VA’s 
Computerized  Patient Record System (CPRS).  This screen is based solely on our 
inclusion/exclusion criteria.   
Veterans will be scheduled for the informed consent, initial screening procedure and 
baseline assessments.   
b) Advertisements, flyers, brochures: Approved media such as these will be placed in 
high visibility areas at each site to recruit possible participants.   
c) Review of VA Administrative Databases: The Chairman’s Office will work with 
appropriate personnel with approved access to these databases to identify potential 
participants.  This identification will occur through a searching of relevant diagnostic and 
procedure codes that are drawn from our inclusion /exclusion criteria.  These lists will be 
provided to the appropriate local study staff who will be responsible for a more focused 
evaluation of these records in CPRS.  For those veterans passing this level of review, 
study staff will contact the veteran’s primary provider who may then discuss project with 

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the veteran. Just as in the provider referral situations, the provider will offer interested 
veterans the options of either having study staff contact them directly or they can 
contact the study staff.  Again, at no time will study staff contact veterans who have not 
expressed their desire to be contacted.  If passing initial eligibility, will be scheduled for 
the informed consent, initial screening procedure and baseline assessments. 
d) Sending messages to providers: E-mails sharing basic study information may be sent
to providers twice a year. Model language includes, “Are you looking for an alternate 
option for your patients with Major Depression Disorder (MDD) who have failed at least 
2 drug therapies?  Consider referring your patient to the TMS Depression Study (CSP 
556: “The Effectiveness of rTMS (repetitive transcranial magnetic stimulation) in 
Depressed Patients.” 
For details, go to http://clinicaltrials.gov/ct2/show/NCT01191333 or contact [insert 
name(s) and title(s) of study team member(s) and their contact information]  
e) Posting study information on SharePoint sites: Basic information about the study as
in 4d above may be placed in local VA SharePoint sites such as Mental Health, General 
Medicine and Women’s Health. 
f) Recruitment postcards will be sent by a direct marketing company, who will generate
a mailing list of veterans who live near the study sites. Interested veterans will contact 
either their Mental Health Provider or the VA rTMS study team for questions or more 
information.  
5. Minorities and Women:  Because the VA population is largely male, the proportion
of females enrolled will not be representative of actual prevalence rates.  Although most 
recruitment will occur in mental health clinics, recruitment within women’s health clinics 
will be used to try to maximize the enrollment of eligible women.  Ethnic and racial 
minorities are well-represented in the VA population and study staff will be trained to 
recognize the variations in symptom presentation characteristic of ethnic and racial 
minorities so that potential participants from these groups will not be excluded. 

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B.  Screening Assessments 
Patients who are screened for possible eligibility for the study will be listed on the Patient 
Screening Log.  After the patient signs the Informed Consent Form, the screening procedures 
and assessments can be initiated.  A template of the Informed Consent Form can be found in 
Appendix A.  The screening phase will last between two and four weeks to allow adequate 
time for all of the assessments to be completed, to assure the patient’s capacity and 
willingness to participate in the study and to ensure that all patients have HRSD24 scores 
above entry criteria for the study within seven days prior to randomization.  If the SI feels that 
the patient may not be capable of giving informed consent, the SI may request a competency 
evaluation using the VA standard clinical protocol.  All assessments and their frequencies of 
administration are listed in Table 2 in Protocol section VI.G.  Although screening data will not 
be used in the primary analysis, it will be retained to determine if participants who entered the 
study were comparable to those who were excluded.  
C.  Randomization to Treatment 
Patients who sign the Informed Consent Form and meet the study eligibility criteria will be 
enrolled into the study and will be randomized into one of 2 treatment groups:  rTMS or sham 
rTMS.  Patients who fail screening may be re-screened at a later time at the discretion of the 
site investigator. 
To randomize a patient into the study, the SI or the SC will submit the electronic randomization 
form.  This computerized system, after verifying eligibility, will randomize a patient to either the 
rTMS or to the sham rTMS treatment group.  A non-sequential treatment number will be 
assigned.    This unique treatment number will be key entered into the device which will be 
associated with a treatment assignment and will enable the rTMS device to deliver the 
appropriate treatment (active or sham) to each patient.  Every attempt will be made to 
randomize a participant so that he/she will receive his/her first rTMS treatment as soon as 
possible after randomization.  Non-sequential treatment numbers will be assigned to ensure 
that investigators cannot initiate a participant on treatment before randomization.  An adaptive 
randomization scheme will be used so that approximately equal numbers of patients will be 
randomized to each treatment group within several important subsets.  These subsets include 
patients with a substance abuse disorder and patients with PTSD.  Enrolling site will also be 

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incorporated into the adaptive randomization scheme.  A “biased coin” procedure will be used 
to make an assignment that will improve overall balance more likely than an assignment that 
will not (Efron 1971).  Imbalance will be calculated by summing the marginal totals for these 
three factors for each treatment group and calculating the difference, D.  If the imbalance is 
less than three, assignments will be made with equal probability; otherwise, the probability of 
assigning to the group that will increase imbalance will be 1/D.  This approach will be 
incorporated within the electronic data capture system. 
D.  Duration of the Study 
The duration of the study will be three and a half years, with a three year enrollment period.  
Each participant will be in the trial for a total of approximately 29-39 weeks (2-4 weeks 
screening, 4-11 weeks acute treatment phase and 24 week follow-up phase).  

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No 
No 
No   
No 
 
E.  Intervention Procedure  
The overview of the experimental design and procedures is presented in Figure 2.  
Sign Consent Form 
Screening Assessments 
Randomization 
Active rTMS 
x 20 sessions 
Sham rTMS 
x 20 sessions 
Remit? 
(HRSD ≤ 10) 
Additional Active rTMS 
5-10 sessions MAX 
Additional Sham rTMS 
5-10 sessions MAX 
Treatment Taper and 
Follow-up 24 weeks 
Screening 
2-4 Weeks 
Acute Treatment Phase 
4-11 Weeks 
Follow-up Phase 
24 Weeks 
Yes 
       Figure 2:  Overview of Research Design 
Remit? 
(HRSD ≤ 10) 
Remit? 
(HRSD ≤ 10) 
Follow-up 24 weeks 
No Taper 
Follow-up 24 weeks 
No Taper 
Yes 
Yes 
Remit? 
(HRSD ≤ 10) 
Yes 

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Acute Treatment Phase.  After randomization, and on the first day of each block of treatment, 
the administrator will determine the motor threshold (MT).  The administrator will then deliver 
left prefrontal active rTMS treatment or Sham (Control) rTMS treatment for 20 to 30 sessions in 
blocks of 5 sessions.  Patients are first tested for “remission” after the first 20 sessions of 
treatment and then again at the 25th and 30th sessions.  “Remission” is defined as a decrease 
in Hamilton Rating Scale for Depression to 10 or less.  Patients will be retested for 
remission following the last treatment in each 5-session block.   
 If a participant remits after the first 20 sessions, the participant will enter the 24 week 
follow-up phase; all participants will receive a minimum of 20 treatments before being 
evaluated for remission; 
 If a participant does not remit after the first 20 sessions of treatment, the participant will 
be offered an additional 5 or 10 sessions of treatment and retested for “remission” after 
25 or 30 sessions.  This procedure may continue for a maximum of 30 sessions total 
treatment.  
 If the participant remits, he/she will enter the 24 week follow-up phase during which they 
will receive a “taper” of treatments over three weeks.  The taper will include 3 treatment 
sessions in the first week, 2 in the second week and 1 in the last week of the taper;  
 If a participant does not remit at the end of 30 sessions of treatment or drops out during 
treatment, the participant will be considered a treatment “failure” for the purpose of the 
primary analyses.  The participant will enter the 24 week follow-up phase.  Patients who 
are treatment “failures” will not receive a “taper” of treatments.   
Units of 5 sessions will normally be delivered over one week’s time.  As is the case with other 
somatic treatments such as electroconvulsive therapy, some consideration of scheduling 
flexibility must be made to accommodate holidays and other events.  These units of 5 sessions 
can be delivered over a minimum of 5 calendar days and should be delivered within 12 
calendar days.  Thus, the entire acute treatment phase would normally take between 4 weeks 
to 11 weeks.  At the end of each treatment block, study staff will enter progress notes for each 
participant in CPRS.  These progress notes will be very brief in nature and contain no results 
or scores of assessments and will serve simply as records of treatment and assessment.  The 
participant’s primary mental health provider will be listed as an additional signer on these 

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notes.  This is to ensure that providers are aware of the veterans progress throughout the 
study and to maintain an open line of communication with study staff. 
Follow-up Phase.  After the acute treatment phase ends, all patients will enter a 24 week 
follow-up period.  Taper treatments are considered part of the Follow-up Phase. Follow-up 
visits will occur approximately monthly during the follow-up phase.  These visits should be 
face-to-face but, in unusual circumstances, telephonic visits may be allowed.  Appropriate 
assessments to measure treatment effects after the acute and follow-up phases will be 
collected as described in Table 2, Assessments and Frequencies of Administration, in Protocol 
section VI.G.   At the end of each follow-up visit, study staff will enter progress notes for each 
participant in CPRS.  These progress notes will be very brief in nature and contain no results 
or scores of assessments and serve simply as records of assessment.  As on the notes in the 
acute phase, the participant’s primary mental health provider will be listed as an additional 
signer on these notes.   
F. Treatment Regimen 
1.  Rationale for Selection of rTMS Stimulation Parameters 
The Planning Committee’s decision regarding the choice of rTMS stimulation parameters in 
this trial was made in a systematic way with data from three sources.  
a.  First, the Planning Committee members performed a thorough literature review of 
the rTMS antidepressant trials performed over the last 15 years (n=70 trials as of 
12/06).  
b. These data were then presented and discussed at a planning meeting attended by 
the rTMS experts on the CSP Planning Committee, and were re-examined in light of 
current neurobiology data.  
c.  Finally, the potential list of parameters were then filtered by the committee in light 
of practicality, safety and feasibility, specifically with respect to use in the VA 
population and whether deviation from parameters used in prior studies would 
potentially jeopardize the other goals of the study, i.e. to maximize comparability with 
other studies.  

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d. Treatment parameters were reviewed by the Study’s Executive Committee prior to
the start of the study and were revised to incorporate the most current information. 
The Planning and Executive Committees then settled on the following dose: 

Power:  120% of motor threshold as separately determined for each patient prior to
treatment/sham sessions

Pulse frequency: 10 Hz

Length of each pulse train: 4 seconds

Time between pulse trains: 10 seconds

Length of treatment: 25 minutes

Total 4000 pulses per session, 5 days/week, 4 weeks/20 session minimum

120,000 pulses total for 30 sessions or 80,000 pulses total for 20 sessions.
There are two major points to be emphasized about these proposed parameters: 
Major Point 1: The proposed parameters are the most likely, based on current 
knowledge, to be potentially effective in the VA population.  
The dosing parameters involve the choice of coil and type of coil, location of stimulation, 
intensity, frequency, daily dose, and total number of pulses.  Each was discussed briefly. 
Location – 66 of the 70 published studies of rTMS as an antidepressant have chosen to 
stimulate over the LDLPFC, following on the initial finding of antidepressant efficacy at this site 
(George et al., 1995).  Although other prefrontal cortex sites have been examined and have 
found antidepressant effects, the total literature at any other site is limited in terms of subjects 
studied and the number of studies.  The LDLPFC site is clearly the most likely region to be 
effective, based on prior studies. (See Section 2 below for a more detailed discussion about 
how to best position the coil to stimulate the prefrontal cortex.)  
Intensity – rTMS antidepressant studies have ranged from dose of 80% MT to 120% MT. 
Older studies used lower intensity stimulation because of safety concerns at the time which 

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have now been relaxed with greater experience.  There have been no studies at intensities 
higher than those proposed in this trial. In several recent studies, 120% MT is sufficient to 
stimulate the prefrontal cortex in all subjects under age 70, even those with prefrontal atrophy 
(Nahas et al., 2004).  It is both tolerable and safe.  Higher intensity stimulation would be risky 
and potentially have more patient dropouts due to pain. 
Frequency – The frequency of stimulation has ranged from less than 1 Hz to 20 Hz. All other 
factors being equal, higher frequency stimulation is more likely to cause a seizure, and is more 
painful.  Many neurobiological effects of rTMS and brain stimulation are frequency dependent 
(e.g. speech arrest only occurs at 6Hz or faster, Epstein et al., 1996).  Although other dosing 
parameters do appear to matter with respect to antidepressant efficacy, the frequency of 
stimulation has not been shown to matter (Gershon et al., 2003).  We thus chose 10 Hz based 
on the safety and tolerability data in the published literature, and because it has recently 
shown effects in the industry clinical trial. 
Daily Dose – The daily dose appears to matter, with more stimulation per day being better 
(Gerson et al., 2003) and (Jorge et al., 2008).  The daily dose in our study is similar to the most 
recent industry trial and the 2006 study by Avery and associates.  However, given the clear 
trend that higher doses are more likely effective, and the recent effectiveness trial at the 
Medical University of South Carolina (MUSC) in depressed patients on medications who 
received 6000 stimuli/day (Hadley et al, in Press, JECT), we have decided to increase the 
number of stimuli given per day from 3000 as was originally proposed and used in the industry 
and NIMH trials, to 4000 stimuli per day. This is much less than was shown safe in the MUSC 
effectiveness trial but nevertheless is a proper modest increase in the number of stimuli over 
the trial. This increase reflects the ever growing safety database with TMS and current 
scientific trends.   
Length of Treatment – Initial studies with rTMS had short exposure times (2 weeks) and were 
likely under treating.  More recent studies show that most patients respond by 4 weeks (20 
sessions), with up to 6 weeks (30 sessions) needed for full response in those showing some 
clinical effects.  
Summary on Parameter Choice – The proposed parameters have shown efficacy in many 
prior studies, and represent the best choice of parameters that would be able to test the 

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hypothesis of whether rTMS works in the VA population.  They essentially are the same 
parameters that were used in the recent NIH trial and in the major industry trial.  The only 
difference is that with accumulating comfort with these parameters, the recent safety revisions 
from Sienna 2008, and several trials where patients were given 6000 stimuli/day or more, we 
have increased the total daily dose to 4000 stimuli.   
Major Point 2: Although there may be improvements in parameters over the next 5-10 
years, these are likely to be minor and not revolutionary.  
rTMS is a relatively new form of therapy, with first reports beginning in the early 1990’s.  Over 
the past 5 years, there have been only minimal changes in the dosing parameters. Although 
there will likely be continued minor improvements, these will likely not be radical and negate 
the results of a VA CSP study.  
There are some basic limitations in pushing the dose much greater than the parameters we 
propose.  We are at the upper limit of where one can safely stimulate with respect to causing 
seizures. Any higher frequencies or longer trains and there is a high risk of producing seizures 
(Wassermann, 1997).  Although one could safely double or triple the number of stimuli given in 
a day (Anderson et al., 2006), this would be infeasible in terms of one person essentially 
spending 5-6 hours in a chair every day for several weeks. We have benefited from the recent 
safety guidelines revisions, where the safe time between TMS trains should be at least twice 
the TMS train. As originally proposed, we stimulated for 4 sec and had 26 seconds rest 
between trains. This was highly inefficient and not needed. We have reduced the intertrain 
interval to 10 seconds, which allows us to safely give more stimuli without extending the length 
of time in the chair for a full session. These more efficient intertrain interval times were shown 
safe and well-tolerated in the MUSC effectiveness trial. 
2. Rationale for Selection of rTMS Stimulation Coil Location
In the early days of rTMS, some researchers developed the ‘5 cm rule’ as a quick and efficient 
method of placing the coil over the LDLPFC (George et al., 1995; 1996).  Basically, one finds 
the best scalp location for stimulating the thumb through a functional search method.  After 
finding this location, one moves 5 cm anterior and in a parasagittal line to find the stimulation 
location for the prefrontal cortex.  This quick method, based on published anatomical atlases, 
works well in clinical settings and obviates the need for costly MRI or CT scans.  It has been 

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used in 65 of the 70 published rTMS antidepressant studies.  The problem with this method is 
that it fails to account for differences in the location of motor cortex (some subjects may have 
motor cortex farther back in their skull), and it does not account for variation in overall brain or 
skull size.  A group elegantly showed that using this algorithm in adults results in actual 
stimulation over premotor cortex in 1/3 of subjects, with the others being stimulated in 
Brodmann areas 9 and 46 (Herwig et al., 2001).  A different approach would be to use a 
system, like that used in EEG electrode placement, which compensates for variations in skull 
size (Herwig et al., 2003).  An even more scientifically rigorous approach would be to use brain 
imaging and individually select the scalp location based on either structural or functional 
anatomy.  While these other systems are more anatomically precise, we do not know the 
intended target within the prefrontal cortex that is maximum for treating depression (if it exists 
as a single well-defined region).  Thus, in the absence of new compelling data showing a 
better system, the study Planning Committee concluded that we should use the 5cm rule, 
which has worked in prior trials.  More recent data has demonstrated that a 6 cm rule results in 
better coil placement and this rule will be used in this study. 
A summary of the acute treatment (intervention phase) regimen can be found in Appendix K.   
G.  Study Assessments 
The assessments and their frequencies of administration are described in Table 2 in Protocol 
section VI.G.   Following Table 2 is a description of each assessment.  
 
 
 
 
 
 
 
 
 
 
 
 

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Table 2:  Assessments and Frequencies of Administration 
Assessment 
2-4 weeks 
Acute Treatment Phase 
Follow-up Phase 
4 - 11 weeks 
24 weeks (6 months) 
End of Session Number 1
PRN 
Taper 
weeks 
Weeks 
Screening/ 
Baseline 
5 
10 
15 
20 
[25] 
[30/ 
last 
1 
2 
3 
4 
8 
12 
16 
20 
24 
86 
Consent 
S* 
01 
Screening Form 
S 
02 
Randomization Form 
B* 
03 
Baseline 
S 
04 
Medical History 
S 
05 
Physical Exam 
S 
x 
06 
Labs 
S 
07 
Structured Clinical 
Interview for DSM-IV-TR 
(SCID-I) 
S 
08 
Current/Past ATHF 
S 
09 
Lifetime Drinking History 
B 
10 
Clinician Administered 
PTSD Scale (CAPS) 
B 
x 
x 
11 
Trauma History 
Questionnaire (THQ) 
B 
12 
Life Stressor Checklist-
revised (LSC-R) 
B 
13 
Six-Item Blessed 
Orientation-Memory-
Concentration  
(BOMC) 
S 
14 
Pregnancy Test 
S2
 Every 4 weeks 
15 
Medication Use 
S 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
16 
Study Visit Form 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
17 
Audiometry: REMOVED 
18 
rTMS Treatment Log 
x 
x 
x 
x 
x 
x 
19 
rTMS Taper Log 
x 
x 
x 
20 
Hamilton Rating Scale for 
Depression (HRSD) and 
MADRS 
S2
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
21 
Beck Depression 
Inventory (BDI) 
B 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
22 
Quick Inventory of 
Depressive 
Symptomatology (QIDS-
C16) 
B 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
23 
Columbia-Suicide Severity 
Rating Scale (C-SSRS) 
S 
24 
Columbia-Suicide Severity 
Rating Scale (C-SSRS) 
F/U 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
25 
Beck Scale for Suicidal 
Ideation (BSS) 
S 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
26 
Beck Hopelessness Scale 
S 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
27 
Quality of Life (VR 36) 
B 
x 
x 

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Assessment 
2-4 weeks 
Acute Treatment Phase 
Follow-up Phase 
4 - 11 weeks 
 
24 weeks (6 months) 
End of Session Number 1 
PRN 
Taper 
weeks 
Weeks 
Screening/ 
Baseline 
5 
10 
15 
20 
[25] 
[30/ 
last 
1 
2 
3 
4 
8 
12 
16 
20 
24 
28 
Neuropsychological 
Battery 
B 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
x 
29 
DAST 
S 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
x 
30 
PTSD Checklist (PCL) 
B 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
x 
31 
MAST 
S 
 
 
 
 
 
x 
 
 
 
 
 
 
 
 
x 
32 
STAXI-2 
S 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
TLFB 
Alcohol/Drug Timeline 
Followback (TLFB) 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
33 
Urine Tox Screen/Alcohol 
Test 
S 
 
x 
 
x 
 
X 
 
x 
 
x 
 
x 
 
x 
 
34 
Termination Form3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
35 
Control Questionnaire 
Before 
and after 
the 1st 
treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
36 
Protocol Deviation 
As required 
37 
Adverse Events (AE) and 
ADE  and Serious 
Adverse Events (SAEs) 
and UADE 
As required 
 
*B= Baseline 
*S= Screening 
1   Sessions 21-25 and 26-30 may not be required if patient goes into remission earlier  
2    Must be conducted within 7 days prior to randomization 
3  Termination Form will be completed at the end of the study OR when a patient decides to 
end study participation prior to the study completion date; i.e., a patient decides to withdraw 
or leave the study for any reason, withdraws consent, or is suspended from the study. 
1. Demographics, Medical History, Physical Exam, Laboratory, Toxicology, Pregnancy 
Test and Medication Use.  Relevant demographics will be collected as to age, gender, 
racial/ethnic grouping, military history and income. In addition, a standard Medical History and 
Physical Exam will be completed as well as laboratory tests including a Complete Blood Count 
(CBC), electrolytes (chemistry), thyroid panel and a liver function test. An alcohol test and 
urine drug toxicology screen will be conducted prior to randomization and also randomly during 
the following time points of study participation:   
a) Acute Treatment Phase: 2nd, 4th, and 6th (if still in acute treatment) weeks  
b) Taper Phase: 2nd week 
c) Follow-up Phase: 1st, 3rd, and 5th months 

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A pregnancy test will be conducted on all female patients of childbearing potential (that is, all 
women except for those who are post menopause for > 2 years or who have a history of 
hysterectomy or surgical sterilization) prior to randomization and every four weeks during the 
study.  Information on medication use (prescription, natural food products, and “over the 
counter”) will be collected at screening and updated after each block of five sessions during 
the treatment phase and every four weeks during the follow-up phase.  
2. Structured Clinical Interview for DSM-IV (SCID) (First et al., 2002).  The Structured
Clinical Interview for DSM-IV Axis I Disorders (SCID) is a semi-structured interview that is used 
to make the major DSM-IV Axis I diagnoses in the most uniform manner possible. 
3. Antidepressant Treatment History Form (ATHF) (Sackeim et al., 1990).  The ATHF
provides a uniform and rigorous method of eliciting and recording a patient’s past experience 
using antidepressant medications. The ATHF provides detailed information about which 
treatments the patient has received during the index episode and over his/her lifetime. Specific 
criteria are used to evaluate the adequacy (e.g., dose and duration) of each treatment trial, and 
a determination is made, for each trial, whether the patient manifested treatment resistance 
(did not satisfactorily respond at adequate dose and duration) or whether the stringent dose 
and duration requirements could not be met (treatment intolerance).  
Measures of Substance Abuse and Post-traumatic Stress 
To perform moderator analyses determining if these comorbid conditions are associated with 
differential response to treatment, relevant measures will be collected.  Since all subjects, at 
the time of the protocol, will not be abusing substances, the most relevant measures will be 
history of duration and severity of substance abuse, in particular alcohol abuse.  Additional 
measures will quantify relevant aspects of PTSD.   
4. Lifetime Drinking History (Skinner & Sheu, 1982).  Lifetime alcohol consumption will be
assessed using the Lifetime Drinking History (LDH) instrument as designed by Skinner and 
Sheu (1982) and refined by Sobell and colleagues (1988, 1990).  LDH is the state-of-the-art 
validated assessment instrument for obtaining quantitative data on the frequency, amount, 
duration, and pattern of lifetime alcohol consumption beginning from the onset of regular 
drinking.  Aggregate indices for total lifetime drinking can be assessed with moderate to high 
reliability (Skinner & Sheu,1982;  Sobell et al., 1990, 1988).  It is recognized that the pattern of 

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drinking behavior (i.e. chronic regular drinking vs. binge drinking) may affect outcome 
measures.  Therefore, drinking assessment will include measures of total alcohol consumption, 
typical and maximum alcohol consumption per occasion, average daily and average monthly 
intake (measures of drinking intensity reflecting both frequency of drinking occasions and dose 
per occasion), both for the last six months  (current drinking) and for lifetime (lifetime drinking 
history).   
5. Michigan Alcohol Screening Test (MAST).  The MAST is self-report measure for the 
detection of alcoholism.  It consists of 25 yes-no questions that are differentially weighted 
depending on the severity of the symptom addressed in each item.  The score ranges for 
interpretation of the MAST are as follows: 0-4 = absence of alcoholism; 5-6 = possible 
alcoholism; 7 and up = probable alcoholism.  The measure will be used to assess alcohol 
abuse at baseline and then at the end of acute treatment (intervention) and the follow-up 
phase. 
6. Drug Abuse Screening Test (DAST) (Skinner, 1982).  The DAST is a self-report measure 
for the detection of drug abuse or dependence on a range of psychoactive substances, other 
than alcohol.  The DAST was adapted from the MAST and shares a similar item structure.  A 
score of 5 or higher is indicative of a possible drug use disorder.   
7. Clinician Administered PTSD Scale (CAPS) (Blake et al., 1995). CAPS will determine 
lifetime and current PTSD. The CAPS measures frequency and intensity of PTSD-related 
symptoms. Possible scores range from 0 to 136. In a recent review of studies utilizing the 
CAPS, (Weathers et al., 2001)  propose the following severity score ranges for interpreting the 
CAPS, which are as follows: 0–19 = Asymptomatic/few symptoms; 20-39 = Mild 
PTSD/subthreshold; 
40-59 
= 
Moderate 
PTSD/threshold; 
60-79 
= 
Severe 
PTSD 
symptomatology; > 80 = Extreme PTSD. Using these recommendations, in the proposed 
study, PTSD positive subjects will be positive for lifetime PTSD, related to any lifetime 
traumatic experience, and will meet CAPS criteria for current, chronic PTSD if they have a 
current CAPS score of > 40; PTSD negative subjects will be those with a current CAPS score 
of < 20. 
8. Trauma History Questionnaire (THQ) (Green, 1996). This is a 24-item self report 
inventory which has been modified to provide data on childhood trauma such as sexual or 

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physical assault.  This scale will be used to determine the presence or absence of childhood 
sexual or physical abuse prior to age 13 and to better characterize the trauma histories of our 
participants.  Responses to items 18-23 focus specifically on the age of occurrence of sexual 
and physical assault.  The Trauma History Questionnaire has been shown to have good test-
retest stability (Green, 1996).     
9. Life Stressor Checklist-Revised (LSC-R) (Wolfe & Kimerling, 1997).  This is a 30-item
structured clinical interview for lifetime exposure to stressful life events.  The scale emphasizes 
a number of different potentially traumatic events and assesses the participant’s emotional 
reaction to the stressors and the time period in which the stressors occurred.  The LSC-R is 
reported to have sound psychometric qualities within various PTSD populations (Wolfe & 
Kimerling, 1997).  This measure along with the Trauma History Questionnaire will be used to 
assess the trauma histories of our participants.   
10. PTSD Checklist (PCL) (Blanchard et al., 1996).  This is a 17 item self report.  Its
limitation is that it is keyed to a single traumatic event; e.g., the patient’s worst experience in 
the military.  Nonetheless, it has adequate reliability and has been shown to correlate well with 
scores from the CAPS.  It will be used for follow-up of symptoms to assess change with 
treatment. 
11. Pure Tone Audiometry.  Section Removed
12. Hamilton Rating Scale for Depression (HRSD).  This measure is the primary outcome
measure and is completed after each block of 5 sessions throughout the study.  The HRSD is 
the “gold standard” of randomized clinical trials for depression, and the primary measure of 
most rTMS studies to date.  This study will utilize the 24-item version of this instrument 
(HRSD24) to evaluate depressed mood, vegetative and cognitive symptoms of depression, 
and comorbid anxiety symptoms.  It provides ratings on current DSM-IV symptoms of 
depression, 
with 
the 
exceptions 
of 
hypersomnia, 
increased 
appetite, 
and 
concentration/indecision.  
The Planning Committee, in making this recommendation, examined the outcome measures 
used in current NIH and industry trials as well as the ACNP criteria for “remission” (Rush et al., 
2006).  The ACNP recommends that outcome measures reflect all major criteria used in the 
diagnosis of MDD.  Neither the HRSD or the MADRS include all criteria however, they are 

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widely used in clinical trials and the ACNP report notes that the field has not followed this 
recommendation and that if one were to use these measures for reasons of comparability (as 
this Planning Committee recommends), the ACNP report suggests the use of other metrics to 
assure that remission is complete.  For that reason, the Planning Committee recommended 
additional use of the Quick Inventory of Depressive Symptomatology (QIDS-C16), which meets 
the ACNP criteria.   
Certification of Ratings of HRSD:  We plan to follow the NIH protocol procedures for 
administration and certification of the HRSD ratings.  This will include the use of a prepared 
script to help administer the HRSD.  Certification of all raters at a participating site will be 
verified prior to enrollment.  This will be done by shipping recordings of mock interviews (non-
patient) to the sites where trained raters have determined a “gold standard HRSD score”.  Site 
raters will then submit their scores. Following NIH procedures, large deviations will be noted, 
and a rater can have an additional test.  This can be repeated for a total of 3 times until the site 
is told they must find another rater. 
Longitudinal Quality Control for HRSD:  Following NIH procedures, to ensure that HRSD do 
not “drift” over time, one HRSD recording will be circulated to evaluators at all participating 
sites every 6 months.  The evaluators will be asked to rate this recording and to return their 
ratings.  Evaluators who drift greater than 3 points on the HRSD total score will receive 
telephone consultation followed by one additional HRSD recording. 
13.  Montgomery Asberg Depression Rating Scale (MADRS).  As another measure of 
depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with 
increasing frequency in recent years to measure outcome in antidepressant efficacy trials.  It 
offers an alternative view of depressive illness, and may be sensitive to depressive symptoms 
that are not easily captured in the context of the HRSD, such as hypersomnia, increased 
appetite, and concentration/indecision. 
14.  Beck Depression Inventory (BDI).  This measure is a 21-item self-report test presented 
in a multiple choice format which measures presence and extent of depression. Each of the 21 
items addresses a specific symptom or attitude that pertains to depressed patients, and which 
are consistent with descriptions of the depression within the peer-reviewed literature. While 
generally deemed less reliable than scales score by a trained rater (for example, the HRSD), 

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the Beck scale is easy to administer, and provides convenient means by which patients can 
effectively communicate their own perception of their mood state. 
15. Quick Inventory of Depressive Symptomatology (QIDS-C16).  The ACNP recommends
that outcome measures reflect all major criteria used in the diagnosis of MDD.  For that reason 
the Planning Committee recommended additional use of the Quick Inventory of Depressive 
Symptomatology (QIDS-C16), which meets the ACNP criteria (Rush et al., 2003).  The HRSD 
does not measure hypersomnia, weight gain or problems with concentration or decision 
making. 
16. Columbia – Suicide Severity Rating Scale (C-SSRS).  Suicide is a rare event. As such,
suicide rates cannot be used as an outcome measure for an rTMS study.  Similarly, the study 
is of too short a duration to expect to find a significant difference in numbers or lethality of 
suicide attempts between treatment and placebo (sham rTMS) groups.  Nonetheless, there are 
two areas that can be expected to change with successful rTMS treatment: preoccupation with 
suicidal ideations or plans.  Because this study uses both a lead in period prior to treatment 
and a sham rTMS treatment group, we will be able to compare the rate of parasuicidal 
behavior in these patients, who are at more serious risk of a suicide completion.  One of the 
newer methods of monitoring patients at risk for suicide is the C-SSRS.  The C-SSRS 
assesses suicidal ideation as well suicidal behavior over a specified time period and is 
frequently employed by the Food and Drug Administration in research to determine if 
suicidality is an adverse effect.  The form will be collected at multiple timepoints in during the 
course of the study.  Initially, it will be collected at baseline to serve as a screener for persons 
reporting suicidal ideation or behaviors in the past six months.  It will also be completed weekly 
during acute treatment and then monthly during the follow-up phase to monitor for the 
presence of suicidal ideation or behaviors.  The sensitivity of this instrument will allow us to 
identify even “minor” suicide “gestures” as well as more serious attempts.   
17. Beck Hopelessness Scale (BHS) (Beck et al., 1974). The Beck Hopelessness Scale is a
self-report measure consisting of 20 “yes/no” items.  A total severity of hopelessness is 
calculated from summing the 20 items and guidelines for interpretation for scores are as 
follows: 0-3 = minimal hopelessness; 4-8 = mild hopelessness; 9-14 = moderate hopelessness; 
and 15-20 = severe hopelessness.  The BHS will be will be given at screening, weekly during 
acute treatment and taper phases and then monthly during the follow-up phase. 

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18.  Beck Scale for Suicide Ideation (BSS).  To help clinicians screen psychiatric patients for 
suicidal ideation, the Beck Scale for Suicide Ideation (Beck and Steer, 1991) was developed, 
and is herein referred to as the BSS.  This self-report measure consists of 21 items and is one 
of the most thorough assessments of both active and passive suicidal ideation.  Respondents 
are asked to rate the severity of each item on a 3-point scale with scores ranging from 0 to 2.  
The first five items on the BSS are regarded as a screener for suicidal ideation and assess 
one’s desire to live, desire to die, reasons to live and reasons to die, and suicidal ideation.  The 
remainder of the BSS assesses the duration and frequency of suicidal ideation, ambivalence 
regarding suicidal ideation, reasons for living / deterrents for suicide, suicide plan / opportunity 
to enact plan, expectations for following through after an attempt, preparations that have been 
made to ready for a suicide, past suicide attempts, and wish to die during past suicide 
attempts.  It should be noted that the psychiatrist responsible for the assessment of the patient 
is responsible for performing a more detailed assessment of any patient showing an increase 
in BSS score.  The BSS will be given at screening, weekly during acute treatment and taper 
phases and then monthly during the follow-up phase. 
Suicidal ideation, hopelessness, agitation, aggression, and depressive symptoms can also be 
derived from the HRSD and the MADRS, which is also being rated on each patient.  The 
advantages of the HRSD and the MADRS are that they are interviewer-scored scales that 
focus not only on ideation, but also on psychotic symptoms, and somatic symptoms.  Thus, 
this study, in contrast to the other multisite trials of rTMS, will not only be different because of 
the population (veterans with TRMD) that it treats, but also because it incorporates five scales 
that enable evaluation of both ideation and intent (CSSRS and BSS), hopelessness (BHS), 
and mood, psychotic, and somatic symptoms (HRSD, MADRS). 
19.  Health Services: Veterans RAND 36 Item Health Survey (VR-36).  The VR-36 (formerly 
known as the SF-36V) is a self-administered survey that measures eight dimensions of health: 
physical functioning, role limitations due to physical health, bodily pain, general health 
perceptions, vitality, social functioning, role limitations due to emotional problems, and mental 
health. It yields scale scores for each of these eight health domains, and two summary 
measures of physical and mental health: the Physical Component Summary (PCS) and Mental 
Component Summary (MCS). The VR-36 includes two additional items that assess how much 
physical and emotional health have changed over the previous year. The VR-36 is a generic 
measure, as opposed to one that targets a specific age, disease, or treatment group. Thus, it 

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has been useful in assessing the health of general and specific populations, comparing the 
relative burden of diseases, differentiating the health benefits produced by a wide range of 
treatments, and screening individual patients. The applicability of the VR-36 is apparent from 
its widespread use.  
20. State-Trait Anger Expression Inventory -2 (STAXI-2).  The STAXI-2 is a 57-item self-
report measure of the experience, expression, and control of anger.  The measure consists of 
six scale, five subscales, and Anger Expression Index which provides a measure of total anger 
expression.  The STAXI-2 is frequently included in risk assessments for violence and will be 
used as such in the current protocol. 
21. Blessed Orientation Memory Concentration Test (BOMC).  The BOMC (Katzman,
Brown, Fuld, Peck, Schechter, & Schimmel, 1983) is a 6-item screening measure of cognitive 
impairment which takes approximately 5 minutes to administer.   The measure consists of 3 
orientation questions, listing months backwards, a name and address memory phrase, and 
counting backwards from 20 to 1. This measure is fairly sensitive to milder levels of cognitive 
impairment. 
22.
Neuropsychological Battery.  We propose to use a battery that is sensitive to the
potential cognitive effects of rTMS.  rTMS may improve cognitive function as depression is 
lifted, or it could have the potential for impairing function.  A battery has been designed to be 
sensitive to such potential effects and has been used in previous studies of the effectiveness 
of rTMS.  We propose to use measures that have been used in previous studies of rTMS as 
they have proven to be sensitive and it will also provide a basis for comparison of the VA 
patients entering this study with patients who have participated in other studies of rTMS.   
The cognitive assessments will be administered at screening, at the end of the acute treatment 
phase and at the end of the 24 week follow-up phase.  These measures are widely used in the 
literature and have been shown to be effective when working with severely depressed patients  
Testing will include measures of Executive Function, Attention, Memory, Visuospatial Ability, 
Processing Speed, Psychomotor Function, and premorbid intelligence.   
Executive functioning will be assessed using the Controlled Oral Word Association (COWA) 
Test, which is a test of verbal fluency.  Participants are asked to produce as many words that 

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begin with a specific letter (F, A, or S) as they can within one minute.  The participant is then 
asked to name as many animal names as possible within one minute (Spreen and Strauss, 
2006).   
Attention will be assessed using the Stroop Color and Word test (Golden, 1978).  This 
measure consists of three pages: a Word page with 100 color words printed in black ink; a 
Color page with 100 X’s printed in colored ink; and a Color-Word page that contains words 
from the Word page printed in colors (the word and the color do not match).  Participants are 
asked to read as many words or name as many colors as possible in 45 seconds.   
The Rey Auditory-Verbal Learning Test (RAVLT; Rey, 1964; Lezak et al., 2004) will be 
used to assess verbal learning and memory.  The measure consists of 15 nouns that are read 
aloud for five trials.  After each trial, the participant is asked to recall as many words as they 
can from the list.  Another list of words, an interference list, will be read after the fifth trial and 
the participant will be asked to recall the words from that list.  Immediately after that recall, the 
participant will be asked to recall as many words from the original list of 15 nouns.  This is then 
followed by a 20 minute delay, during which other measures of the cognitive assessment will 
be administered.  The participant will be asked to recall the original list of 15 words after this 20 
minute delay.  Finally the participant will be asked to identify the original 15 words after being a 
read a story that contains all of the original 15 words. 
The Judgment of Line Orientation (JLO; Benton et al., 1994) will be used to assess 
visuospatial ability.  There are two alternate forms that each consist of 30 items with an 
additional 5 practice items.  Items are presented in a spiral bound booklet with stimuli 
appearing in the upper part of the booklet and the multiple choice card appearing in the lower 
part.  The participant is asked to indicate on the multiple choice card the lines that match the 
direction of the lines on the stimulus card.   
Processing speed will be assessed using the Symbol Digit Modalities Test (SDMT; Smith, 
1991).  Participants are presented with a coding key consisting of nine abstract symbols.  They 
must scan the coding key and record the corresponding number as quickly as possible.  The 
participants are given 90 seconds to complete the task. 
Psychomotor functioning will be assessed using the Trail Making Test: Parts A and B (TMT; 
Reitan & Wolfson, 1993).  In Part A, the participant is asked to connect, in order, 25 encircled 

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numbers that are dispersed randomly on a page.  The participant is then asked to connect 25 
encircled numbers and letters in an alternating order in Part B.  Both Part A and Part B include 
practice exercises to ensure the participant understands the nature of the task.  All tasks are 
timed. 
The North American National Adult Reading Test (NAART; Blair & Spreen, 1989) will be 
used as an estimate of premorbid intellectual functioning.  This measure consists of 61 items 
that are presented in two columns on a page for the participant to read.  Participants are asked 
to read each word aloud as the examiner marks the errors on a score card. 
All of the measures in the cognitive assessment are paper and pencil measures that will be 
administered by research staff.  Staff will be trained in the proper administration and scoring of 
the cognitive assessment.  
The cognitive assessment is expected to last approximately one hour at screening as well as 
at each follow-up.  
23. Control Questionnaire.  A questionnaire will be used before and after the first treatment
session, and at the end of the final study visit to elicit patient perception of whether they were 
on active or sham rTMS treatment.  
H. Adverse Events (AEs) and Adverse Device Effects (ADEs) 
1. Adverse Device Effect (ADE) and Adverse Event (AE)
Definitions 
An Adverse Device Effect (ADE) is defined by 21 CFR 812.3(s) and CSP Global Standard 
Operating Procedure (SOP) 3.6 as any adverse effect/event caused by or associated with the 
use of a device. 
An Adverse Event (AE) is defined by the ICH for Clinical Safety Data Management and CSP 
Global SOP 3.6 as any untoward physical or psychological occurrence in a human subject 
participating in research. The AE does not necessarily have to have a causal relationship with 
the pharmacological product, study intervention or assessment. An AE can, therefore, be any 
unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease 
associated with the use of a medicinal (investigational) product. 

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Reporting 
In CSP #556, collecting and recording all ADEs and AEs will begin at the time the patient signs 
the informed consent form and will continue throughout the follow-up phase. All events will be 
recorded on the appropriate case report form.  
Relatedness involves an assessment of the degree of causality between the study intervention 
and the event.  Site investigators will be asked to provide an assessment of relatedness.  The 
assessment provided by the site investigator is part of the information used by the sponsor to 
determine if the adverse event or effect presents a patient safety concern.  Pursuant to CSP 
Global SOP 3.6, an ADE is deemed to be associated with the use of the study device if there is 
“a reasonable possibility that the experience may have been caused by the device or by 
participation in the trial.” Thus, all adverse events or effects with a reasonable causal 
relationship to the rTMS treatment should be considered “related”.  A definite relationship does 
not need to be established.  The following levels of relatedness will be used in CSP #556: 
Not attributed to the rTMS treatment 
Possibly attributed to the rTMS treatment 
Attributed to the rTMS treatment  
2.  Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)  
Definitions  
Serious Adverse Events (SAEs) are a subset of adverse events and are defined by the ICH for 
Clinical Safety Data Management and CSP Global SOP 3.6 as any untoward medical 
occurrence that; 
Results in death  
Is life-threatening  
Requires inpatient hospitalization or prolongation of existing hospitalization 
Results in persistent or significant disability or incapacity  

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Is a congenital anomaly/birth defect or 
Any other condition that, based upon medical judgment, may jeopardize the subject and 
require medical or surgical treatment to prevent one of the above outcomes 
In addition, due to the potential increased risk of rTMS among depressed patients, seizures 
(not including syncope), suicide attempts, and any patient reports of significant hearing loss 
are considered Serious Adverse Events for the purpose of CSP #556 regardless of whether 
these events meet any of the above criteria.  Participants will be assessed for subjective 
hearing problems during Screening, near midpoint of Acute Treatment Phase, End of Acute 
Treatment, and at the Final Follow-up Visit.  
An Unanticipated Adverse Device Effect (UADE) is defined by CSP Global SOP 3.6 as:  “Any 
serious adverse effect on health or safety or any life-threatening problem or death caused by, 
or associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application, or any other 
unanticipated serious problem associated with a device that relates to the rights, safety or 
welfare of patients”.  For this study an UADE is considered a category of SAE, which will be 
reported on the same form. 
Collecting and Recording 
For CSP #556, all SAEs and UADEs will be recorded on the SAE form, regardless of cause. 
The site investigator will be asked to determine whether the serious adverse event is related 
to: 
rTMS Device 
rTMS treatment 
Disease progression of depression 
Medications used to treat depression 
Collecting and recording SAEs/UADEs will begin at the time the patient signs the informed 
consent form and will continue throughout the follow-up phase. For a patient who ends study 
participation prior to the study’s completion date, unresolved SAEs will be monitored and 

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reported for 30 days after the  “End of Study” date for that patient. In addition, the investigator 
must collect all SAEs reported to them for a period of 30 days after the study’s completion. 
There are additional reporting requirements beyond using the CSP #556 policy and forms. 
Sites are responsible for submitting all information required by VA Central IRB policy. Please 
visit the VA CIRB website at http://www.research.va.gov/vacentralirb/ for  current policies, 
instructions and forms.  
Specific VA Central IRB links 
a. What must be reported to the VA Central IRB: 
http://www.research.va.gov/vacentralirb/policies.cfm#4 
b. Table of Reporting Requirements to the VA Central IRB: 
http://www.research.va.gov/programs/pride/cirb/CIRB-Table-of-Reporting-
Requirements.pdf 
3.  Expedited Reporting of Serious Adverse Events (SAEs) and Unanticipated Adverse Device 
Effects (UADEs) 
The CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC or PCC) will be 
responsible for initially evaluating all serious adverse events for patient safety concerns and 
will confer with the Study Chair (or another physician member of the Executive Committee if 
the Study Chair is unavailable) as required during this evaluation process. After being 
reviewed by the Study Chair, the PCC Director and the CSPCC Director, any event deemed to 
be related, serious and unexpected will be reported to CRADO, study investigators, and  FDA. 
Expedited Reporting by sites to the Study Sponsor (CSP):  All Serious Adverse Events (SAEs) 
which includes Unanticipated Adverse Device Effects (UADEs) require prompt reporting, within 
72 hours of the site investigator being made aware of the event. The SAE reports will be 
forwarded within 72 hours of discovery of an SAE by the study site to Perry Point CSPCC who 
will immediately notify the CSPCRPCC and the Chairman’s Office. If the SAE is not resolved at 
the time the event is reported, the site must monitor and provide SAE follow-up information at 
least every 30 days until the SAE becomes resolved. The site must handle requests for SAE 
Follow-up information in the same prompt manner that the original SAE reports are handled 

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Expedited Reporting by the Sponsor to the FDA:  The Chairman and Study Pharmacist will 
review the SAE report to assess completeness of documentation and to determine whether the 
SAE requires expedited reporting to the FDA.   
Specifically, if an event meets the criteria for unexpectedness (i.e., not previously reported), 
seriousness (by definitions in section H.2.), and relatedness, it will be reported to the FDA 
within 10 working days  for UADEs and within 7 calendar days for unexpected SAEs (Safety 
Reports) of the sponsor (Cooperative Studies Program) receiving the report as required by 
regulation.    
4. Data Monitoring Committee (DMC) Reporting of Adverse Events, Adverse Device Effects,
Serious Adverse Events, and Unanticipated Adverse Device Effects. The Clinical Research 
Pharmacist and the Study Biostatistician will generate tabulations of AEs and SAEs and 
present a summary of these to the DMC on a schedule set by the DMC. The DMC will also 
determine when they should be unblinded to treatment assignment for the reviewing of 
adverse event data. The DMC will advise the CSP Director concerning whether the study 
should continue or be stopped for safety reasons. 
5. Role of the Site Investigator in Adverse Event Monitoring
The site investigator (as well as other site personnel) will be responsible for following adverse 
event and adverse device effects reporting requirements. These responsibilities include: 
a. Reviewing the accuracy and completeness of all adverse events/device reports;
b.
Knowing
and 
complying 
with 
the 
VA 
CIRB 
(accessible 
at 
http://www.research.va.gov/vacentralirb/) and VHA Handbook 1058.01 Research 
Reporting 
Compliance 
Requirements 
section 
6 
(accessible 
at 
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3116) 
reporting 
requirements for unanticipated problems. 
The VA Central IRB has reporting 
requirements separate from and beyond Sponsor reporting requirements. See the link 
above for the Table of Reporting Requirements in Section VI.H.2; 
c. Reporting to the VA Central IRB safety issues reported to the site by the sponsor;

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d.  Closely monitoring research participants at each study assessment visit for any new 
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) 
which includes Unanticipated Adverse Device Effect (UADE).  
6.  The Study Sponsor (Perry Point CSPCC, CSPCRPCC, and Study Chair) is responsible for 
the following procedures: 
a. The Study Pharmacist promptly reviews newly submitted SAE reports to assess 
completeness of documentation and to determine whether the SAE requires expedited 
reporting to FDA.  SAE reports which may require further reporting to FDA are brought 
to the attention of the Chair’s Office for further medical advice. 
b.   The Perry Point CSPCC tracks receipt of follow-up reports of unresolved SAEs. 
c.   SAE reports that warrant immediate notification to VA Central Office are handled 
CSPCRPCC forwarded through the Directors of the Perry Point CSPCC and 
CSPCRPCC to VA Central Office. 
d.   The CSPCRPCC is sent electronic files of adverse events reported semiannually 
and serious adverse events reported quarterly for assignment of MedDRA codes. 
e.   Tracking of unresolved SAEs by the Sponsor ceases 30 days after the patient 
completes the study or withdraws consent to be followed. 
I. Dropouts and Follow-up Procedures 
This is an “intent-to-treat” protocol and any data of patients who are randomized to treatment 
will be retained for data analyses.  As patients will remain under the care of their primary VA 
psychiatrist before, during and after participation in this study, the patient’s primary VA 
psychiatrist will remain central to the recruitment, participation and follow-up processes.  
Throughout a patient’s participation in the study, the site investigator will communicate with the 
patient’s primary VA psychiatrist to discuss the patient’s condition, reactions and any clinically 
significant adverse events.  If a patient drops out or leaves the study for any reason or is 
suspended from the study for breaking study rules, every attempt will be made to contact the 
patient and complete a Termination Form.   

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J. Missed Visits and Study Termination 
If a patient decides to withdraw their consent, a Termination Form will be completed.  The 
Termination Form will include questions regarding the reason for termination and the patient’s 
impression of the efficacy of the treatment to that point.  If a patient is lost to follow-up or fails 
to come to clinic, the patient’s primary VA psychiatrist will be informed.   
The patient may be terminated from the study at any time if the SI deems that the patient has 
not been following the protocol.  This will generally be done only when the protocol violation 
significantly increases the risk associated with continuing to participate in the study.  A 
Termination Form will be completed.  Patients who are terminated prior to the end of the acute 
treatment phase will be considered treatment failures. 
Any female participant who becomes pregnant during the acute treatment phase of the study 
will discontinue the study treatments for safety reasons as the effects of rTMS on unborn 
fetuses is not known at this time and she will immediately enter the follow-up phase. Any 
female participant who gets pregnant during the follow-up phase of the study will continue to 
be followed-up in accordance with the protocol and complete all assessments.  Women who 
become pregnant at any time during the study will be asked to sign a release of information in 
order for the study staff to access the medical records for the outcome of the pregnancy.  
Women who become pregnant during participation will be referred to an OB/GYN clinic.       
K. Follow-up Procedures for Non-remitters and Non-responders 
Following the 4-11 week acute phase, all non-remitting and non-responding rTMS patients 
(defined as HRSD score percent change from screening less than 50%) will be provided 24 
weeks of follow-up.  Patients will remain under the care of their primary VA psychiatrist before, 
during and after participation in this study.  Their primary VA psychiatrist will adjust 
medications in compliance with the protocol, which allow adjustments by the psychiatrist as 
clinically indicated after the acute treatment phase.   
L. Protocol Violations 
All protocol violations will be promptly reported to the study sponsor on the form developed for 
such reporting. In addition, protocol violations which meet the CIRB’s criteria for reporting (see 

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VA CIRB Form 129 Report of Protocol Deviations, Violations, and/or Noncompliance) must be 
reported to the CIRB as specified in that document. 
M. Participant Compensation 
Participants are compensated for the purpose of their time and effort put forth. Participants 
involved at any point up to week 1 of treatment reach payment #1 of $40, treatment week’s 2-6 
participation are payment #2 of $300, follow-up visits 1-6 equal payment #3 of $60 for a total of 
up to $400 per participant.  Participants may reach a follow up stage after only 4 weeks of 
treatment; they will still earn the payment 2 of $300 and will then go into the follow up phase. 
Some individuals will reach follow up at earlier stages than others, which will not vary the 
amount of payment.   
If a subject terminates early from one of the three stages, they will be paid the amount 
equivalent to the stage they are in, i.e., if they are in treatment week 3 and terminate, they will 
receive payment #1 and payment #2.  
N. Genetics 
Section Removed. 
VII. DATA MANAGEMENT AND CASE REPORT FORMS 
A.  Assessments, Case Report Forms (CRFs) and their Frequency of Administration and 
Collection   
Please refer to Table 2 in Protocol section VI.G for a list of assessments, CRFs, and their 
frequencies of administration and collection.  
B.  Data Collection and Data Entry 
Based on source documents collected at the study sites, data will be collected and then 
entered at the site using electronic data capture (EDC).  The VA Cooperative Studies Program 
Coordinating Center (CSPCC) at Perry Point will develop the EDC templates.  CSPCC will 
function as the centralized data management center for the study. The medical record, 
laboratory reports and all related documents will be the source of verification of data entered.  
Data should be entered on an ongoing and regular basis throughout the study and in 

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accordance with the instructions in the study operations manual.  The SI is responsible for 
maintaining accurate, complete and up-to-date records for each participant.  The SI is also 
responsible for maintaining any source documentation related to the study, including any films, 
tracings, computer discs or tapes.   
CSPCC will be responsible for the validation of the clinical database, ensuring data integrity, 
and for the training of all participating staff on applicable data management procedures. 
InfoPath will be utilized in this clinical trial.  Any discrepancies (i.e., missing data, range 
validation, cross check) that are discovered during the verification process will be flagged with 
quality control notes and clinical sites will be required to either correct or confirm flagged 
entries.  The CSPCC will send Quality Control Reports to the Chairman’s Office and to the 
participating sites on a monthly basis.  These reports will summarize the quality and quantity of 
the data that each site has submitted. 
When the study is completed and all data have been entered into the clinical database and the 
database has been checked for quality assurance and is locked, the CSPCC statisticians, in 
accordance with the Analytical Plan Section of this protocol, will perform statistical analysis of 
the data.  Periodically, during the study, CSPCC will prepare various types of summary reports 
of the data so that progress of the study can be monitored.  These reports will be prepared for 
the Data Monitoring Committee (DMC) and others, as appropriate. 
C.  Study Documentation and Records Retention 
Study documentation includes all CRFs, quality control notes, workbooks, source documents, 
monitoring logs and appointment schedules, sponsor-investigator correspondence and 
regulatory documents (e.g., signed protocol and amendments, IRB correspondence and 
approved consent form and signed informed consent forms, Statement of Investigator form, 
and clinical supplies receipt and distribution records).  
Source documents include all recordings of observations or notations of clinical activities and 
all reports and records necessary for the evaluation and reconstruction of the study.  Thus, 
source documents include, but are not limited to laboratory reports, audiology reports, patient 
diaries and progress notes, hospital charts or pharmacy records and any other reports or 
records of any procedure performed in accordance with the protocol. 

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Whenever possible, the original recording of an observation should be retained as the source 
document; however, a photocopy is acceptable provided that it is a clear, legible, and exact 
duplication of the original document. 
Research records for all study participants including medical history and physical findings, 
laboratory data, and results of consultations with the primary care VA psychiatrist are to be 
maintained by the investigator in a secure storage facility for 3 years after the end of the study 
or until notified by CSPCC.  These records are to be maintained in compliance with IRB, State 
and Federal requirements, whichever is longest. Exceptions to the 3-year retention 
requirement can be found in 45 CFR 74.53 and 92.42  (e.g., if any litigation, claim, financial 
management review, or audit is started before the expiration of the 3-year period, the records 
must be retained until all litigation, claims, or audit findings involving the records have been 
resolved and final action taken). It is the investigator’s responsibility to retain copies of the 
completed CRFs until notified in writing by CSPCC that they can be destroyed.  In all 
instances, the site must get permission from CSPCC prior to disposition of any study 
documentation and materials.  
All records with identifiers will be stored indefinitely in accordance with the VA Records Control 
Schedule. 
D.  Data Security Plan 
All data collected for this study will be handled and used in compliance with both the CSP and 
the Perry Point CSPCC data security plans.  All patient level data will be treated as protected 
health information.  Data will be transmitted from participating sites using secure servers.  
Study personnel at CSPCC, CRPCC, and at participating sites will be required to complete 
annual training courses.  These courses will cover good clinical practices, human subjects’ 
protection, cyber security, and privacy policy.  Any data security breaches will be immediately 
reported.  Access to patient level data at CSPCC or CRPCC, will be obtained through user 
accounts which will be protected by strong passwords.  File protections will be used to limit 
access to members of the study group.  Patient level data will never be stored on portable 
storage devices unless it is encrypted, explicitly authorized, and use specific. 
 

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VIII. BIOSTATISTICAL CONSIDERATIONS
A.  Sample Size 
The primary hypothesis of the study is that in VA patients with TRMD, rTMS will result in a 
greater remission rate at the end of acute treatment than sham rTMS.  The primary outcome 
measure in this study is success or failure to achieve remission from depression as defined by 
a score on the Hamilton Rating Scale for Depression (HRSD24) of 10 or less.  The primary 
analysis will be done as an “intent-to-treat” analysis, i.e. patients will be analyzed in the groups 
to which they were randomized and drop-outs will be considered treatment failures.  The 
primary hypothesis will be addressed using a logistic regression model with PTSD diagnosis, 
history of substance abuse, and site as covariates.   
Based on review of the studies reported in the Introduction Section, the Planning Committee 
felt that a 10% difference between treatments would be of clinical relevance given the severity 
of the illness.  With a sample size of 180 per group, the proposed study will have a power of 
81% to detect an absolute difference between groups of 10% in the percentage of those 
participants who remit (6% sham and 16% rTMS).  Thus, a total of 360 patients will be 
randomized.  This goal of 360 patients, larger than any previous study, also provides a 
measure of protection should some assumptions be wrong. 
B.  Analysis Plan 
1. Site Effects and Baseline Comparability
Site effects will be tested using a logistic regression analysis examining the effect for 
Treatment in a model that includes Site and Site x Treatment interaction.  Baseline 
comparability among the treatment groups will be evaluated with respect to such 
variables as demographics (e.g., age, gender, race), baseline values of outcome 
measures (e.g., the HRSD, QOL measure(s), suicidality, etc.), antidepressant currently 
being used, etc.  Chi-square and analysis of variance techniques, as appropriate, will be 
used to determine any differences in distribution of the variables across the treatment 
groups.  Any variable that appears to be different between the groups (p< 0.10) will be 
evaluated to determine whether such imbalances had any effect on conclusions.   

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2.  Analysis of Primary Outcome Measure 
The primary outcome measure in this study is success or failure to achieve remission 
from depression after a maximum of 30 sessions of rTMS or sham treatment.  
“Remission” is defined by a score on the HRSD24 of 10 or less after a maximum of 30 
sessions of treatment.  The primary analysis will be done as an “intent-to-treat” analysis, 
i.e. patients will be analyzed in the groups to which they were randomized, and patients 
who dropout before completing the Acute Treatment Phase will be considered treatment 
failures for the primary analysis on remission rates.  The primary analyses and several 
secondary analyses will be conducted on outcome measures such as “remission” and 
“response” which are binary and defined by specific criteria.  Logistic regression models 
with PTSD diagnosis, history of substance abuse, and site as covariates will be used for 
these analyses.   
C.  Additional Analyses 
In addition to the main analysis using the entire randomized or “intent-to-treat” cohort, logistic 
regression models will be used for “completers” and also for “fully compliant” subjects to 
provide further information about treatment effects.  For example, it would be expected that if 
rTMS had a significant clinical effect, its effect would appear greater in “completer” and “totally 
compliant” cohorts, than in the entire randomized cohort.  Other analyses will be performed on 
secondary measures to further provide useful clinical information.   
Some secondary outcome measures, such as sustained response rate (“recovery”) and 
response on secondary outcome measures, can also be analyzed using logistic regression 
models.  Other potential secondary analyses include continuous variables such as:  change in 
suicidality, change in cognitive function and change in quality of life (QOL).  The effect of rTMS 
on such continuous measures will be determined using random regression and similar 
techniques that maximize the use of available data in repeated measures designs.   
Potential moderators of treatment response also will be analyzed using multivariate analysis of 
variance or regression techniques.  In addition, exploratory analyses will be performed using 
signal detection techniques (Receiver Operator Characteristics or ROC) to attempt to identify 
novel moderators predictors of response.  The following gives examples of some potential 

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analyses that may be carried out that use random regression techniques, which may be more 
sensitive to change than the logistic regression analyses.   
a. Random regression approach to efficacy analyses
Random regression models will be used to test and evaluate treatment efficacy (see 
e.g., Gibbons et al., 1993).  Such models trace the individual trajectories over time and,
in effect, use available information to impute any missing data for comparable subjects.  
They thus compare the groups on a parameter describing the trajectory (e.g., the 
subject’s response rate over time).  This method not only minimizes loss of power and 
bias due to dropouts (for analytical purposes there are none), but also amplifies the 
reliability of measures using repeated measures per subject and thus usually increases 
power.   
Short-Term Efficacy (Baseline to End of Acute Treatment).  This approach can be used 
to replicate and enhance the understanding of the main analyses.  Data to be entered 
into the random regression analyses will include those collected at baseline and after 
sessions 10, 20 or possibly 30 if the patient receives treatment at that time.  We will use 
a linear model on ln(t+1) to model the typical “fish hook” shape of the response 
trajectory, assuming an autoregressive covariance structure within individuals with 
treatment group as the independent variable.  The primary outcome measure will be the 
slope of HRSD change.  This random regression parallel of the primary analyses will 
provide complementary information to assess if rTMS is superior to sham rTMS.  
Secondary random regression analyses also will be performed on each of the other 
outcome measures.  The effect of site will also be examined as in the primary analyses.  
Longer-term efficacy (End of Treatment to End of Follow-up).  Data to be entered into 
analyses will include those collected from weeks 4 to 24 of follow-up, and analytic 
techniques will parallel those described above.  This will allow a comparison of loss of 
treatment effect from the end of the treatment to the end of follow-up, i.e. it will address 
questions of pattern of “recovery” and “recurrence.”   

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b. Random regression approach to individual differences in response 
(Moderators) 
Multiple regression analyses will be performed to determine if, as hypothesized, there 
will be individual differences in the efficacy of treatment depending upon specific 
predictors.  This analysis will be done by adding the predictor variable and its interaction 
with treatment to the Random Regression Model used above.  A significant interaction 
indicates a differential effect size depending on predictor status.  Separate predictor of 
response analyses will be performed for each set of outcome data.  These analyses are 
used to determine in whom or under what conditions improvement occurs.  For 
example, we expect that younger age will predict a better response to rTMS than to 
sham rTMS.  The initial measures to be used in these analyses will be severity of 
symptoms at baseline, type of comorbidity (PTSD, substance abuse, or both), duration 
of illness and prior treatment resistance.   
In these exploratory analyses, alternative measures might prove to have different 
abilities to predict response to rTMS.  Our consultant, Dr. Kraemer is an expert in the 
use of signal-detection methods to make such determinations (Kraemer, 1992).  
Because of the potential that collinearity may be a problem among potential moderators 
and mediators, Dr. Kraemer proposes that any examination of effects of the proposed 
predictor variables be corrected for the potential effect of initial level of severity of 
depression.   
D.  Assessing Size of Treatment Effect 
Although data analyses can indicate the statistical significance of results, a statistically 
significant result does not in and of itself imply that a finding is useful in a practical sense.  
Therefore, in addition to testing for statistical significance, we will convey practical significance 
by reporting treatment effect sizes and their confidence intervals (Kraemer & Kupfer, 2006).  
We believe that such evaluations will yield conclusions that are directly relevant to the 
development of treatment programs of the type proposed here.  

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E.  Supplemental Statistical Analyses 
We will examine the degree of convergent validity between depression measures that are 
gathered on the same days. The analyses proposed are not presented as a complete list of all 
analyses likely to be performed.  They simply provide a brief outline of the major statistics that 
will be obtained.   
F.  Economic Analysis 
We will collect and report information on the incremental health care cost of rTMS based on its 
implementation at multiple VA medical centers (see Appendix M). Specifically, we will estimate 
the incremental per patient program (or direct) cost of rTMS relative to usual care over the 
course of an rTMS treatment (lasting no more than 11 weeks for most study participants) in our 
proposed implementation).  Sensitivity analyses will be used to derive upper and lower 
estimates of resource use and incremental costs.  
Although the costs and benefits of rTMS could be substantial in magnitude, we believe a full 
cost, cost-effectiveness, or cost-benefit study would be premature during this initial phase of 
effectiveness testing.  rTMS could either increase or decrease specialty mental health 
treatment costs depending on the magnitude of any cost-offset. It also could bring about 
significant societal benefits by preventing suicide and lowering depression-related morbidity.  
In a full evaluation, these and other potential benefits of rTMS would be weighed against direct 
and indirect costs.  The sham control design does not allow for natural economic comparison 
to treatment as usual, and many of the economic benefits (or costs) resulting from treatment 
may emerge beyond the proposed study period (9 to 17 weeks).  Therefore, in the current 
study, economic analyses will focus primarily on the direct treatment and implementation costs 
and cost-consequences.  We will, however, conduct a preliminary and limited study of its 
incremental effects on cost per sustained remission using comparisons of clinical outcome at 
24-weeks post-treatment across the two treatment arms as our measures of incremental 
effectiveness (see Appendix M). We believe these estimates will provide important preliminary 
evidence on the potential cost-effectiveness of rTMS treatment. 

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IX. QUALITY ASSURANCE PROCEDURES 
A.  Rater Training 
To insure the validity and the integrity of this research study, a formalized training program will 
be provided to the appropriate staff who will be conducting key assessments and for the staff 
who will be administering the rTMS treatments. Both pre-study and annual certification will be 
required.   
B.  Good Clinical Practices (GCP) 
The Site Monitoring, Auditing and Resource Team (SMART) is responsible to assure that 
participating sites conduct the study in compliance with Good Clinical Practices.  SMART 
consists of the Good Clinical Practices (GCP) Monitoring Group (GCPMG) and the GCP 
Standards and Resource Group (GCPSRG).  GCP Monitors will visit participating sites 
annually to monitor investigator records and practices as described in the Monitoring Plan to 
be prepared for this trial.  To promote GCP in the trial, SMART will also develop written GCP 
guidance and tools specifically for the trial and provide training in the use of these materials 
and in the principles of GCP at the start of the trial.  Training is provided at the kick-off meeting 
and during GCP implementation visits made by SMART to each site at the start of subject 
enrollment. Finally, GCP Auditors may visit sites at any time throughout the trial to assess 
GCP compliance as requested by Perry Point CSPCC, or other members of the study 
management and monitoring teams. 
In summary, SMART will accomplish the following:  
1. Prepare a written Monitoring Plan for review and concurrence of Perry Point CSPCC 
Director and Study Chairman. 
 2. Prepare and provide sites with GCP tools and guidance to aide in organizing files and 
maintaining records in compliance with the protocol and GCP. 
 3. Present GCP training at the study kick-off meeting. 
 4. Conduct site GCP implementation visits to participating sites to aid in implementing 
the training, practices and tools provided by Perry Point CSPCC and SMART. 

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5. Conduct routine monitoring visits to each participating site at least annually as
directed by the study’s Monitoring Plan. 
6. Conduct a closeout-monitoring visit to each site at the end of the study to assure
completion of all study tasks and appropriate archiving of study records. 
7. Perform independent quality assurance audits at selected sites as requested by Perry
Point CSPCC and other members of the study management and monitoring teams if 
approved by the Directors of CSPCC and CSPCRPCC. 
X.  STUDY MANAGEMENT, MONITORING AND TRAINING 
A.  Study Management 
The Site Investigator, the TMS Treater and the Study Coordinator at each of the participating 
sites will conduct the daily activities of the study.  The Study Chairman’s Office, the 
Cooperative Studies Program Coordinating Center (CSPCC), and the Cooperative Studies 
Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) will provide 
leadership and guidance to the local sites, as well as performing their assigned tasks, as 
described below: 
1.
Office of the Chairman.  The Chairman’s Office, located at the Palo Alto VA
Medical Center, will coordinate and administer all aspects of the study and will closely 
monitor the progress of the study.  This office will provide leadership for the study and 
will be in routine contact with the participating sites to ensure that the study is performed 
in accordance with the protocol and to encourage the local study team to keep 
enrollment and visit activities on schedule.  The Chairman will preside over all Study 
Group Meetings and will represent the study, along with the Study Biostatistician and 
the pharmacist (as needed) at all meetings of outside review committees.   
2. CSPCC.  The CSPCC, located in Perry Point, Maryland, will provide administrative,
data management and statistical support for the study.  CSPCC staff will provide 
guidance on completion of forms and data quality queries.  They will develop editing 
software and manage the study database.  All reports generated during the ongoing 
phase of the study and the final statistical analyses will be the responsibility of the 
CSPCC.  In tandem with the Chairman, CSPCC will monitor study progress to ensure 

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that the study is proceeding as scheduled.  A CSPCC study team dedicated to this 
study has already been established.  This team is headed by the Study Biostatistician 
and will include the Project Manager, the Statistical Programmer, the Database 
Programmer and two Computer Assistants. 
3. CSPCRPCC. The CSP Clinical Research Pharmacy Coordinating Center 
(CSPCRPCC) manages the pharmaceutical aspects of multi-center pharmaceutical and 
device clinical trials including patient safety monitoring. CSPCRPCC acts as a liaison 
between the study participants, the FDA and the manufacturers of the study drug(s) or 
device(s) in all VA Cooperative Studies that involve drugs or devices. The CSPCRPCC 
develops Drug or Device Treatment and Handling Procedures: obtains and distributes 
the study drug(s) or device(s); prepares a Drug or Device Information Report for each of 
the study drugs to assist in the Human Rights Committee Review; and provides advice 
and consultation about drug or device-related matters during the study. CSPCRPCC is 
responsible for monitoring and reporting the safety of trial participants through the 
review, assessment, and communication of adverse events and serious adverse events 
reported by study personnel with reviewing responsibilities occur through ongoing 
communication with the Study Chairman, Executive Committee, Data Coordinating 
Center, and CSP Central Office. The reporting activities include the filing of regulatory 
documents involving adverse events with the FDA and manufacturers to meet federal 
regulations and CSP policies. In conjunction with the Data Coordinating Center, the 
CSPCRPCC trends and analyzes safety data in order to prepare reports for various 
committees including the Data Monitoring Committee (DMC), Institutional Review 
Boards (IRBs), Study Executive Committee(s), and study investigator meetings.  
4. Participating Sites.  All participating sites must be a VA Health Care System facility 
that agrees to adhere to the study protocol, meet the recruitment target of the study and 
provide full administrative support, including adequate clinic space and any necessary 
equipment.  Each site is expected to be able to enroll at least 40 patients during the 
three year enrollment period or until full study enrollment is achieved. 
5. Site Investigator (SI).  The SI from each of the participating sites must 
enthusiastically support the study and be willing to devote sufficient time and energy to 
ensure that the study’s goals are met.  The SI must have at least a 5/8 VA appointment 

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and be a physician in good standing and be board-certified in Psychiatry and/or 
Neurology.  The SI will assume responsibility for the following aspects of the study: 
Meet recruitment goals and ensure timely follow-up of participants. 
Ensure the integrity of the study protocol and the data collected from his/her site. 
Provide ongoing supervision to study staff and ensure that the study staff is sufficiently 
trained to administer the assessment tools as well as the rTMS device. 
Provide for adequate coverage for the study in the absence of any study staff. 
Obtain initial and continuing reviews by the local Human Subjects Subcommittee/IRB 
and the local Research and Development (R&D) Office; will submit all written approvals 
to the CSPCC in a timely manner. 
TMS Treater (TT): Nurse Practitioner (NP), Registered Nurse (RN), or Physician 
Assistant (PA).  A full-time NP, RN or PA, preferably one experienced in mental health 
and/or research, will be recruited for the study and will function under the supervision of 
the SI.  The NP, RN, or PA will screen patients, obtain medical histories, perform 
physical examinations, and conduct structured assessments including the ATHF.  The 
NP, RN, or PA will be BCLS certified and will be trained and fully credentialed to 
administer the rTMS treatments. If a site is unable to recruit or retain a NP, RN, or PA 
for this study, the SI will contact the Study Chairman to discuss other potential staff who 
would possess the appropriate skills and credentials for this position. 
Study Coordinator (SC).  A full-time SC, preferably one who is experienced in TRMD 
and clinical trials, will be recruited for the study and will be under the direct supervision 
of the SI.  The SC will recruit and randomize patients into the study, perform 
assessments including the SCID, HRSD, the MADRS, the CSSRS, the BSS, the BHS, 
the BDI, the neuropsychological battery and the Health Services assessments.  The SC 
will perform other administrative tasks including completion of case report forms, 
correction of edits and data clarification requests.  The SC will also contact study 
participants with appointment reminders and for follow-up as needed. 

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B.  Monitoring 
A number of groups will be charged with monitoring the various aspects of the study.  These 
groups include the Study Group, the Executive Committee, Data Monitoring Committee, the 
Site Monitoring, Auditing and Resource Team (SMART) and the Cooperative Studies Scientific 
Evaluation Committee (CSSEC).  With the exception of CSSEC, each of these committees will 
meet at the beginning of patient intake, six to nine months later, and yearly thereafter. CSSEC 
may review the study at its midpoint.  This monitoring will not preclude the annual monitoring 
that the local R&D Committee and Human Subjects Subcommittee/IRB must also perform. 
1.  Study Group   
The study group consists of all participating SIs, TTs and SCs as well as staff from the 
Chairman’s Office, CSPCC, and CSPCRPCC.  This group meets annually to discuss 
the plans/progress of the study, as well as to identify any problems encountered during 
the conduct of the trial.  No outcome data are presented to this group. 
2.  Executive Committee   
The Executive Committee is the management and decision-making body for the 
operational aspects of the study.  This committee is chaired by Dr. Jerome Yesavage, 
and includes the Study Biostatistician, the CRP, a minimum of three SIs and outside 
consultants, if necessary.  This committee monitors the performance of participating 
sites and quality of data collected.  The Executive Committee formulates plans for 
publications and oversees the publication and presentation of all data from the study.  
Permission from this committee must be granted before any study data may be used for 
presentation or publication.  This group also does not receive outcome data during the 
course of the study.  Executive Committee decisions that need to be made between 
regularly scheduled meetings will be made during periodic phone conferences.    
3.  Data Monitoring Committee (DMC)   
The DMC is a group of outside experts in the area of TRMD, clinical trials and 
biostatistics that reviews the progress of the study and monitors patient enrollment, 
outcomes, adverse events, and other issues related to patient safety.  The DMC makes 
recommendations to the CSP Director as to whether the study should continue or be 

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modified or terminated.  The DMC can consider patient safety or other circumstances as 
grounds for early termination, including either compelling internal or external evidence 
of treatment differences or infeasibility of addressing the study hypotheses (e.g., poor 
patient intake, poor adherence to the protocol).  The DMC will meet annually to review 
data reports prepared by the CSPCC.  At the six-month interval between the annual 
meetings, the DMC will receive a data report for their review.  Any member of the DMC 
can ask for a meeting of the group if he/she feels that it is necessary, based upon the 
data. This group will receive outcome data during the course of the study. 
 In order for the DMC to make its recommendation for continuation of the study, it will be 
necessary for them to see the analyses for the primary outcome measure every time 
that the report is run and it is possible to calculate the primary outcome measure. 
Periodic monitoring of interim results can significantly affect the probability of making an 
incorrect decision.  A number of formal techniques have been developed for interpreting 
interim results. At the organizational meeting, the DMC will select the technique that it 
wants to use to monitor the study. Suggested techniques are the Haybittle-Peto and 
Lan-DeMets group sequential boundaries. For the Haybittle-Peto method, a constant z-
statistic is used as the monitoring boundary. The Lan-DeMets procedure produces 
decision boundaries that are quite conservative over the first several looks and then 
gradually converges to the nominal alpha levels as the final look is approached.  Figure 
3 gives an example of the Lan-DeMets boundaries for five looks at an alpha level of 
0.05. 

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4.  Human Rights Committee (HRC)   
The Human Rights Committee (HRC) will conduct annual site visits to ensure that 
patients’ rights and safety are being properly protected.   
5.  Internal Reviews   
The Study Chairman, the Study Biostatistician, the CRP and the CSPCC Project 
Manager will communicate regularly and frequently to review study status.  Discussion 
items will include overall and site-specific enrollment, regulatory issues, protocol 
compliance and data completeness and quality.  Action plans to deal with identified 
problems will be developed. 
6.  Site Monitoring, Auditing and Resource Team (SMART)   
The Site Monitoring, Auditing and Resource Team (SMART) will conduct monitoring 
visits to each participating site to monitor investigative records and practices to ensure 
sites are in compliance with both the study protocol and GCP.  These site visits will 
occur annually or more frequently if directed by the study’s Monitoring Plan.  
Independent quality assurance audits will also be conducted at selected sites, if 
needed. 
-6
-4
-2
0
2
4
6
1
2
3
4
5
Z Test Statistic Value 
Looks 
Figure 3.  Lan De - Mets Group Sequential Monitoring Boundaries 

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7. Special Procedures for Monitoring of Substance Abuse
Under the exclusion criteria, we have listed substance abuse within the previous 90 
days because evaluating withdrawal symptoms or cravings in the context of a 
depression study complicates the evaluation.  Furthermore, alcohol withdrawal, cocaine 
and stimulant abuse, and barbiturate withdrawal are all associated with an increased 
risk of seizures.  More critically, actively abusing drugs or alcohol is associated with a 
higher risk of completed suicide.  Thus, beginning to abuse alcohol or drugs could well 
be a prelude to a completed suicide and must be immediately addressed. 
Prior to study randomization, all potential participants will submit to both an alcohol test 
and a urine drug toxicology screen.  Those that have positive results on either of these 
tests will be excluded from participation.  For those that are eligible for participation, 
they must also complete alcohol tests and urine drug toxicology screens at randomly at 
the following time points: 
1)
Acute Treatment Phase: 2nd, 4th, and 6th (if still in acute treatment) weeks
2)
Taper Phase: 2nd week
3)
Follow-Up Phase: 1st, 3rd, and 5th months
Throughout the study, site staff will also monitor participants’ use of substances 
including alcohol, OTC medication, opiates, and street drugs for possible abuse through 
the use of self-report measures.  Prior to each treatment session, study staff will ask 
participants if they have used any substances in the past 24 hours and if so, how much 
was used.  Study staff will further monitor participants’ alcohol and other substance use 
with weekly administrations of the Alcohol / Drug of Choice Timeline Followback Method 
(TLFB) (Sobell and Sobell, 1992) during the acute and taper phases of treatment, and 
monthly administrations of the TLFB during the follow-up phase.  The TLFB is a self-
report measure of recent drinking behavior or substance abuse.  Using a calendar, the 
patients will retrospectively estimate their daily consumption of alcohol and other 
substances over the past 7 days prior to the interview. This will enable the study staff to 
quantify the amount of substances patients are using, therefore tracking changes in 

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these amounts and addressing problematic substance use at the earliest possible 
instance. This tool is used for monitoring purposes during the study, not for enrollment. 
Participants will also complete the MAST and DAST during screening, at the end of 
acute treatment, and at the end of the follow-up phase.  
Use of substances is not prohibited during study participation; however, participants are 
discouraged from consuming more than one alcoholic drink per day during their 
participation.  If it is determined that a participant is abusing substances, study staff will 
alert the SI.  At that time, the SI will evaluate the situation and determine if it is 
appropriate for the participant to continue.  The Site PI will use the “VA/DoD Clinical 
Practice Guideline for Management of Substance Use Disorders” (The Management of 
Substance Use Disorders Working Group, 2009) as a reference in the evaluation of the 
situation. 
Additionally, during the informed consent process, participants must agree to allow 
study staff to contact their primary mental health provider should the participant begin to 
abuse substances during the course of their participation in the treatment trial.  Potential 
participants that do not agree to this portion of the informed consent will not be allowed 
to enroll. 
If at any point someone presents for treatment and is visibly intoxicated, study staff will 
follow their local VA policy regarding the assessment of intoxication and behavior risk.  
From that point forward, the participant will be excluded from participation in the study 
and coded as a treatment failure.   
To summarize, stopping criteria for treatment will include: 
1. Alcohol use greater than one glass of wine/day or equivalent. Use of alcohol 
when patient has been warned of serious medication/alcohol interactions, will 
also fit this criteria.  If patients are found to be noncompliant with this, the Site 
Investigator will decide whether to administer treatment and evaluate the 
patient’s appropriateness for continued participation. 
2. Abuse of illegal drugs. If patients are found to be noncompliant with this, the Site 
Investigator will decide whether to administer treatment and evaluate the 

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patient’s appropriateness for continued participation.  An exception to this will be 
patients who used marijuana up until the past 30 days. Ongoing THC abuse will 
change the status to “discontinued from the study”. 
3. Abuse or misuse of prescribed psychiatric medications will also result in either
withdrawal from the study or inclusion as a noncompliant patient.
8. Special Procedures for Safety of Potentially Suicidal or Dangerous Patients
Appropriate and frequent assessment of suicidality is important when working with 
severely depressed individuals.  Our approach to this is comprehensive in nature and 
includes multiple clinical interviews (CSSRS and HRSD) as well as self-report measures 
(BSS and BHS) that are given at baseline, weekly during acute treatment and the taper 
phases, and monthly during the follow-up phase.  The following criteria will be used for 
the assessment of suicidality:  
Baseline 
a)
CSSRS: the endorsement of items 4 or 5, indicating Active Suicidal Ideation with
Some Intent to Act, without Specific Plan or Active Suicidal Ideation with Specific Plan 
and Intent, OR the endorsement of an Actual Attempt, an Interrupted Attempt, an 
Aborted Attempt, or Preparatory Acts or Behaviors in the 6 months prior to assessment 
will trigger a clinical evaluation by the Site Investigator, the patient’s primary mental 
health provider, or a mental health emergency clinician. 
b)
HRSD: a score of 2 or greater on items 10 (Anxiety-Psychic) or 11 (Anxiety-
Somatic) or a score of 4 on item 9 (Agitation) IN combination with a score of 3 or greater 
on item 3 (Suicide) will trigger a clinical evaluation by the Site Investigator, the patient’s 
primary mental health provider, or a mental health emergency clinician. 
c)
MADRS: A score of 4 or greater on item 10 (Suicide Intent) of the MADRS will
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 

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d)      BSS: any positive response to an item on the BSS could indicate suicidal ideation 
thus triggering a clinical evaluation by the Site Investigator, the patient’s primary mental 
health provider, or a mental health emergency clinician. 
e)     BHS: A score of 9 or greater indicating moderate hopelessness on the BHS will 
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
f)     STAXI-2: Scores above the 75th percentile or below the 25th percentile on the 
STAXI-2 will trigger an assessment of danger to self or danger to others. 
 Acute Treatment and Taper Phases 
a)      CSSRS: the endorsement of items 4 or 5, indicating Active Suicidal Ideation with 
Some Intent to Act, without Specific Plan or Active Suicidal Ideation with Specific Plan 
and Intent, OR the endorsement of an Actual Attempt, an Interrupted Attempt, an 
Aborted Attempt, or Preparatory Acts or Behaviors since the last assessment will trigger 
a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
b)      HRSD: a score of 2 or greater on items 10 (Anxiety-Psychic) or 11 (Anxiety-
Somatic) or a score of 4 on item 9 (Agitation) IN combination with a score of 3 or greater 
on item 3 (Suicide) will trigger a clinical evaluation by the Site Investigator, the patient’s 
primary mental health provider, or a mental health emergency clinician. 
c)      MADRS: A score of 4 or greater on item 10 (Suicide Intent) of the MADRS will 
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
d)      BSS: any positive response to an item on the BSS could indicate suicidal ideation 
thus triggering a clinical evaluation by the Site Investigator, the patient’s primary mental 
health provider, or a mental health emergency clinician. 
e)     BHS: A score of 9 or greater indicating moderate hopelessness on the BHS will 
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 

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f)
STAXI-2: Scores above the 75th percentile or below the 25th percentile on the
STAXI-2 will trigger an assessment of danger to self or danger to others. 
Follow-up Phase 
a)
CSSRS: the endorsement of items 4 or 5, indicating Active Suicidal Ideation with
Some Intent to Act, without Specific Plan or Active Suicidal Ideation with Specific Plan 
and Intent, OR the endorsement of an Actual Attempt, an Interrupted Attempt, an 
Aborted Attempt, or Preparatory Acts or Behaviors since the last assessment will trigger 
a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
b)
HRSD: a score of 2 or greater on items 10 (Anxiety-Psychic) or 11 (Anxiety-
Somatic) or a score of 4 on item 9 (Agitation) IN combination with a score of 3 or greater 
on item 3 (Suicide) will trigger a clinical evaluation by the Site Investigator, the patient’s 
primary mental health provider, or a mental health emergency clinician. 
c)
MADRS: A score of 4 or greater on item 10 (Suicide Intent) of the MADRS will
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
d)
BSS: any positive response to an item on the BSS could indicate suicidal ideation
thus triggering a clinical evaluation by the Site Investigator, the patient’s primary mental 
health provider, or a mental health emergency clinician. 
e)
BHS: A score of 9 or greater indicating moderate hopelessness on the BHS will
trigger a clinical evaluation by the Site Investigator, the patient’s primary mental health 
provider, or a mental health emergency clinician. 
f)
STAXI-2: Scores above the 75th percentile or below the 25th percentile on the
STAXI-2 will trigger an assessment of danger to self or danger to others. 
If a patient is determined to be suicidal, either based on the CSSRS, HRSD, MADRS, 
BSS, BHS, STAXI-2, clinical evaluation, or by statements made by the patient, a clinical 
evaluation will be immediately conducted by the Site Investigator, by the patient’s 
individual mental health provider, or a mental health emergency clinician.  The patient 

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will not be left alone until the evaluation has been completed and a decision made about 
disposition in conjunction with the Chief of Mental Health Outpatient Clinic or the Mental 
Health Emergency clinician. 
 A common practice is to stop a treatment if a patient makes a suicide attempt. Because 
this may occur early in treatment, before a patient is adequately treated, we would elect 
to continue treatment with the patient in an inpatient unit if the patient agrees to 
continue the trial.  Discharge would be based on the patient’s ability to adhere to a 
modified safety plan (listing behaviors and strategies in the event of increasing suicidal 
impulses, including returning to the ER).  Monitoring of suicidal behavior within the VA is 
subject to national and local medical center directives.  This protocol is designed to 
follow all such directives and not to preclude any.   The suicide assessment and 
management plan must follow the established written plan of the site institution’s guide 
from their mental health service. 
 For all patients enrolled in the study, we will develop a safety plan agreed upon with the 
primary mental health provider and the patient as a condition of participation in the 
study.  All safety plans will be created according to the VA manual, “Safety Plan 
Treatment Manual to Reduce Suicide Risk: Veteran Version” (Stanley and Brown, 
2008).  This plan will include support from the VA, family contacts and friends, and other 
people the patient trusts.  The safety plan will also incorporate the VA national suicide 
hotline resource phone number:  1-800-273-TALK (8255) as a support outlet. Failure of 
the patient to comply with the safety plan will require stopping study treatments and 
aggressively treating the suicidality.  
Similarly, as a condition of participation, we will insist that patients with a history of 
suicidality have all firearms either removed from their residence or placed under lock 
and key, including trigger locks, with guns and ammunition locked separately and the 
keys given to another family member or friend.  Suicide is an impulsive act and since 
our patients know how to use firearms effectively, the decision to make a suicide 
attempt will more likely be fatal if a firearm is available.  Thus, another stopping point for 
persons with a history of suicidality will be a violation of the firearms agreement and/or 
the procurement of a new firearm during the study. 

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A certain percentage of seriously depressed patients will actually have a bipolar II or 
even bipolar I disorder which is undiagnosed, often because the patient sees the 
hypomania as “normal” or even optimum functioning. The onset of acute mania or a 
mixed state, both of which carry a significant risk of suicide, will also necessitate 
discontinuing study treatments and beginning appropriate treatment for bipolar disorder. 
Another way we are attempting to decrease the suicide risk to the patient is to enable 
the patient to continue in treatment with his/her primary mental health provider and to 
continue taking all medication except those which would convey an increased risk of 
seizures (which would likely have resulted in the patient’s having been excluded).  
Should the patient drop out of outpatient treatment or if we receive information from the 
primary mental health provider that the patient is imminently suicidal, we will institute 
appropriate safety measures and discontinue study treatments if a major change in 
medication or treatment is necessary. Similarly, any patient who is so imminently 
suicidal (or homicidal) that s/he would require involuntary treatment, would no longer 
meet criteria for continuing study treatments.  Once the suicidal patient has regained 
capacity (i.e., is no longer involuntarily hospitalized), if the patient so desires and 
treatment is not contraindicated, s/he may be re-consented and may resume treatment 
sessions.  
If after 100 patients are enrolled 3% of the total enrolled participants have a completed 
suicide or 6% have attempted suicide, enrollment will be suspended pending an 
analysis of the SAE data by the DMC.  The DMC will review all reports of suicides and 
suicide attempts carefully to determine whether suicide risks are excessive.  If so, 
recommendations for restart of study enrollment may entail modifications to procedures 
which would be subject to IRB and FDA approval.  If risk of suicide is not deemed 
excessive, the study will be restarted without modifications. All suicide attempts and 
completions will be considered SAEs, and as such, will be reported to the study 
executive committee, Central IRB, and the DMC by the Clinical Research Pharmacist 
and Study Biostatistician.  The DMC will monitor all SAEs regularly (at least every 6 
months) throughout the study and assess potential for increased risks to patients. The 
DMC may also impose requirements for more frequent monitoring of SAEs.  We 
recognize that study termination or modification based on serious adverse events, such 
as suicide attempts, ultimately rests with the DMC, the Central IRB, and the study 

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executive committee and that more stringent stopping points may be initiated during the 
study.  
9. Special Procedures for the Monitoring of Seizures
If at any point during study participation, a participant has a seizure (not including 
syncope), that participant will be withdrawn from the study treatments immediately (they 
will still be followed for protocol assessments).  All seizures (not including syncope) will 
be considered serious adverse events, and as such, will be reported to the DMC by the 
Clinical Research Pharmacist and Study Biostatistician.  We will suspend enrollment if 
10 participants experience a seizure (not including syncope) during study participation, 
and request that the DMC evaluate the SAE data, to determine if enrollment of new 
patients should be resumed without protocol changes, if protocol modifications should 
be made before resuming enrollment, or if the study should be terminated. In the event 
a patient on bupropion has a seizure associated with TMS treatment, enrollment and 
treatment of patients on any dose of bupropion will be suspended pending evaluation by 
the study Executive Committee and DMC as to (a) whether the event was a true seizure 
or merely syncope (b) whether the patient was receiving active treatment and (c) other 
circumstances that might have contributed to the seizure.  Bupropion use could be 
reinstated if the Executive Committee, DMC, CIRB, and FDA agree that such action is 
appropriate. We recognize that study termination or modification based on serious 
adverse events, such as seizures, ultimately rests with the DMC and the study 
executive committee and that more stringent stopping points may be initiated during the 
study.   
C.  Training 
Prior to the initiation of the study, a kick off meeting of the Study Group will be held.  This 
meeting will include discussions of the study protocol, clinical and administrative details of the 
study, the roles/responsibilities of the SI and of the participating sites, assessment of workload, 
the informed consent process, regulatory issues and recruitment goals.   
In conjunction with the kick-off meeting, training sessions will be held for the study staff. 
Training will include the correct use of all data collection forms, study definitions, recruitment 
strategies, and techniques of conducting patient assessments and rTMS treatment 

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administrations (Appendix O).  Particular problems and unique features of evaluating and 
following patients with TRMD will be discussed.  Potential barriers to successful study 
implementation will be identified as well as resolution techniques.  The goal of this meeting is 
to ensure that all staff is thoroughly familiar and comfortable with the essential aspects of the 
study. A GCP training course will also be held in conjunction with the kick-off meeting to 
ensure all study personnel are familiar with the principles of good clinical practices.  
XI. RESEARCH RESULTS & CONFIDENTIALITY
A.  Confidentiality 
During this research study, personal information (name, address, social security number, date 
of birth) and health information, will be collected by VA research personnel, and used for the 
scientific goals of the research study.  The information collected will be kept confidential as 
required by law.  This does not prevent the researchers from disclosing voluntarily, without the 
patient’s consent, information that would identify the patient if there is reason to believe they 
are experiencing suicidal or homicidal tendencies.  Any reports or publications resulting from 
this study will not include any information that could identify the patient.  Study codes will be 
used for all study reports generated to help maintain confidentiality.  
A Certificate of Confidentiality has been obtained from the Food and Drug Administration 
(FDA).  This helps protect participant privacy by allowing investigators to refuse to release 
personal and other research information outside of the research study, even by a court order.  
By law, information can still be released in cases of suspect child abuse, elder abuse, intent to 
harm oneself or others, or if the participant has an infectious disease for which State or 
Federal law requires reporting.  The Certificate of Confidentiality does not prevent the 
participant or a participant’s family from releasing data about the participant or his/her 
involvement in this study.   
B.  Publication of Research Results 
The policy of the Cooperative Studies Program is that outcome data will not be revealed to the 
participating investigators until the data collection phase of the study is completed.  This policy 
safeguards against possible biases affecting the data collection.  The regular and ex-officio 
members of the Data Monitoring Committee will be reviewing the outcome results to ensure 

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that the study will be terminated if a definitive answer is reached earlier than the scheduled 
end of the study. 
All presentations and publications from this study will follow CSP policy as stated in the CSP 
Guidelines.  The presentation or publication of any or all data collected by participating 
investigators on patients entered into the Department of Veterans Affairs Cooperative Study is 
under the direct control of the study’s Executive Committee.  This is true whether the 
publication or presentation is concerned with the results of the principal undertaking or is 
associated with the study in some other way.  No individual participating investigator has any 
inherent right to perform analyses or interpretations or to make public presentations or seek 
publication of any or all of the data other than under the approval of the Executive Committee. 
The Executive Committee has the authority to establish one or more publication committees, 
usually comprised of subgroups of participating investigators and some members of the 
Executive Committee, for the purpose of producing manuscripts for presentation and 
publication.  Any presentation or publication, when formulated by the Executive Committee or 
its authorized representatives, should be circulated to all participating investigators for review, 
comments, and suggestions, at least four weeks prior to submission of the manuscript to the 
presenting or publishing body. 
All publications must give proper recognition to the Study’s funding source, and should list all 
participants in the study.  If an investigator’s major salary support and/or commitment are from 
the VA, it is obligatory that investigators list the VA as his/her primary institutional affiliation. 
Submission of manuscripts or abstracts must follow the usual VA policy; ideally, a subtitle 
states, “A Department of Veterans Affairs Cooperative Study.”  The CSP also requires that 
every manuscript be reviewed and approved by the CSPCC Director prior to submission as a 
final quality control step.  Mechanisms for appeal by a dissatisfied investigator will follow 
procedures defined by the VA Office of Research and Development. 
Participation in Department of Veterans Affairs Cooperative Studies is voluntary.  Any 
investigator who cannot accept these operation guidelines regarding publication policy should 
not volunteer to participate in the study. 

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C.  Planned Publications 
Following completion of the study, a manuscript will be prepared for the primary outcome.  This 
manuscript will describe the effect of rTMS on various measures of depressive symptoms.  
Additional manuscripts may be prepared to report on secondary outcome findings, including 
effects of rTMS on suicidality, cognitive function and quality of life. 
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repetitive transcranial magnetic stimulation in depression: preliminary report. Neuropsychiatry 
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51:602-3. 

APPENDIX A 
HUMAN RIGHTS ISSUES  

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HUMAN RIGHTS COMMITTEE MINUTES and 
INFORMED CONSENT FORMS 
HRC Minutes dated 08/11/2005 
HRC Minutes dated 09/16/2005 
HRC Minutes dated 09/28/2005 
HRC Minutes dated 03/20/2007 
HRC Minutes dated 05/15/2007
HRC Minutes dated 03/19/2009 
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A Comment on Informed Consent 
 
It is the responsibility of study staff to protect veterans and ensure that 
their participation is based upon an sufficient understanding of the study.  
Thus, informed consent is one of the pillars of ethical human subjects 
research.  Study staff are obligated to work with veterans so that they 
have the opportunity to make an informed decision as to whether or not 
to participate in research.  A key component in the informed consent 
process is the dialogue between the study staff and the veteran.   
 
As an additional safeguard to ensure that all participants are making 
an informed decision is the inclusion of a quiz at the conclusion of the 
informed consent document.  This Attachment item, true/false quiz 
addresses major points from the informed consent document and serves 
as a point of discussion between study staff and the veteran.  Should a 
veteran answer any of the items incorrectly, study staff must use this 
opportunity to more fully discuss that information from the informed 
consent with the veteran.  This discussion should continue until study 
staff are satisfied that the veteran is clear on the issue at hand.  Thus 
this is not a pass/fail test and no data will be collected from this 
document.   
 
There may be instances when study staff question a “consent 
capacity.”  Should this occur, study staff are to follow their local VAs 
guidelines for the assessment of capacity to consent to participate in 
research.  If the local VA does not have such guidelines, study staff will 
receive guidance from the Chairman’s Office as to how to proceed with 
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such an evaluation.  Key components of consent capacity assessment 
including components of the research such as the study purpose, 
experimental components, associated risks and benefits, voluntary 
nature of participation and alternatives to participation. The determination 
of whether a prospective subject is capable of providing informed 
consent is based on a consideration of relevant study factors and an 
individual’s consent capacity. 
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V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _  
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _  
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y     
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
F O R V A C E N T R A L I R B U S E O N L Y  
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
L SI A p pr o v al D at e:    n/ a 
L SI V erifi c ati o n D at e:     n/ a  
I N T R O D U C TI O N 
Y o u ar e b ei n g i n vit e d t o t a k e p art i n a r e s e ar c h st u d y t h at i s b ei n g f u n d e d b y t h e D e p art m e nt of 
V et er a n s Aff air s.  B ef or e y o u d e ci d e t o t a k e p art, it i s i m p ort a nt f or y o u t o k n o w f o ur t hi n g s.  
W 
h y t h e r e s e ar c h i s b ei n g d o n e.  W 
h at it will i n v ol v e.  W 
h at t h e p ot e nti al ri s k s ar e.  W 
h at t h e 
p ot e nti al b e n efit s ar e.    
R e a d t h e i nf or m ati o n b el o w cl o s el y.  Di s c u s s it wit h f a mil y a n d fri e n d s if y o u wi s h.  A s k st u d y 
st aff a b o ut a n yt hi n g t h at i s n ot cl e ar or if y o u w o ul d li k e m or e d et ail s.  T a k e y o ur ti m e t o d e ci d e. 
If y o u d o d e ci d e t o t a k e p art, y o ur si g n at ur e o n t hi s c o n s e nt f or m will s h o w t h at y o u r e c ei v e d all 
of t h e i nf or m ati o n b el o w.  It will al s o s h o w t h at y o u w er e a bl e t o di s c u s s a n y q u e sti o n s a n d 
c o n c er n s y o u h a d wit h a m e m b er of t h e st u d y t e a m. 
Y o u will b e a s k e d t o a n s w er q u e sti o n s ( Att a c h m e nt # 1)  a b o ut t h e i nf or m ati o n i n t hi s c o n s e nt 
f or m t o s h o w t h at y o u u n d er st a n d it. 
Y o u will r e m ai n u n d er t h e c ar e of y o ur pri m ar y V A p s y c hi atri st b ef or e, d uri n g a n d aft er 
p arti ci p ati o n i n t hi s st u d y. 
T E R M S 
T h er e ar e s o m e t er m s y o u m a y n e e d t o k n o w w hil e r e a di n g t hi s c o n s e nt f or m: 
r T M S ( r e p etiti v e Tr a n s cr a ni al M a g n eti c Sti m ul ati o n) :  r T M S u s e s bri ef p ul s e s of m a g n eti c 
e n er g y t o sti m ul at e n er v e c ell s i n t h e br ai n.     
TR  M D ( Tr e at m e nt R e si st a nt M aj or D e pr e s si o n) :  M aj or D e pr e s si o n i s a s eri o u s p s y c hi atri c 
ill n e s s.  S o m e of t h e s y m pt o m s ar e f e eli n g s a d or bl u e, h o p el e s s, h el pl e s s, a n d w ort hl e s s.  
O t h er s y m pt o m s ar e pr o bl e m s sl e e pi n g, c h a n g e s i n a p p etit e, g uilt, a n d t h o u g ht s of d e at h.  
TR  M D i s a t y p e of d e pr e s si o n w h er e dr u g s h a v e n ot w or k e d v er y w ell. 
S h a m Tr e at m e nt:  I n s h a m tr e at m e nt s, t h e d o ct or or n ur s e g o e s t hr o u g h t h e m oti o n s wit h o ut 
a ct u all y tr e ati n g.   T hi s will l o o k, f e el a n d s o u n d li k e t h e r e al tr e at m e nt b ut will n ot sti m ul at e t h e 
br ai n. T hi s i s li k e u si n g a pl a c e b o.  A pl a c e b o i s a pill t h at l o o k s li k e a r e al pill b ut d o e s n ot 
c o nt ai n t h e r e al dr u g.  T h e s h a m tr e at m e nt will b e u s e d b y a b o ut h alf t h e p arti ci p a nt s. 
r T M S m a c hi n e:  A n r T M S m a c hi n e i s a d e vi c e t h at c a n d eli v er a hi g h n u m b er of m a g n eti c 
p ul s e s p er s e c o n d.  T h e m a g n eti c p ul s e s ar e d eli v er e d t hr o u g h c oil s t h at ar e e n c a s e d i n pl a sti c. 
T h e m a c hi n e c o n si st s of a c o m p ut er c o n s ol e, m u c h li k e a d e s kt o p c o m p ut er, c o n n e ct e d t o a 
'  w a n d' .  T h e w a n d i s c oll e cti o n of wir e s wr a p p e d i n pl a sti c.  T hi s w a n d i s n ot m a g n eti c w h e n 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 2 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _  
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _  
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y     
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
F O R V A C E N T R A L I R B U S E O N L Y  
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
L SI A p pr o v al D at e:    n/ a 
L SI V erifi c ati o n D at e:     n/ a  
t h er e i s n o el e ctri cit y g oi n g t hr o u g h it.  W 
h e n t h e m a c hi n e s e n d s el e ctri cit y t hr o u g h t h e w a n d, 
t hi s cr e at e s a p o w erf ul b ut t e m p or ar y m a g n eti c fi el d t h at tr a v el s t hr o u g h s ki n a n d b o n e s.  D uri n g 
r T M S s e s si o n s, y o u sit i n a c o mf ort a bl e c h air n ex t t o t h e c o n s ol e, a n d t h e w a n d r e st s o n y o ur 
h e a d.  T h e w a n d i s u s e d t o f o c u s t h e m a g n eti c p ul s e s o n c ert ai n p art s of t h e br ai n. 
B A C K G R O U N D A N D P U R P O S E 

T h e p ur p o s e of t hi s st u d y i s t o fi n d o ut if r T M S h el p s p e o pl e wit h d e pr e s si o n w h o h a v e
n ot b e e n h el p e d b y m e di c ati o n or w h o h a v e n ot b e e n h el p e d e n o u g h b y m e di c ati o n.  A
m a g n eti c c oil will b e pl a c e d o n y o ur h e a d.  T hi s c oil u s e s s h ort p ul s e s of m a g n eti c
e n er g y t o sti m ul at e t h e p art of y o ur br ai n b el o w t h e c oil.

T h er e h a v e b e e n m or e t h a n 7 0 r e s e ar c h st u di e s u si n g r T M S, a n d s o m e d e vi c e s,
i n cl u di n g o n e si mil ar t o w h at i s u s e d i n t hi s st u d y, ar e a p pr o v e d b y t h e F D A f or t h e
tr e at m e nt of d e pr e s si o n.  H o w e v er, t h e d e vi c e a n d tr e at m e nt pr ot o c ol a s u s e d i n t hi s
st u d y i s still c o n si d er e d ex p eri m e nt al.  W 
e h o p e t o l e ar n w h et h er or n ot r T M S h el p s
p e o pl e w h o h a v e m aj or d e pr e s si o n t h at h a s n ot b e e n h el p e d b y dr u g s.  Y o u h a v e b e e n
s el e ct e d a s a p o s si bl e p arti ci p a nt b e c a u s e y o u h a v e d e pr e s si o n t h at d o e s n ot a p p e ar t o
h a v e b e e n h el p e d b y dr u g s.

T hr e e h u n dr e d a n d six t y v et er a n s at ar o u n d 9
 V A M e di c al C e nt er s a cr o s s t h e U nit e d
St at e s will b e i n t hi s st u d y.  A b o ut 4 0 will c o m e fr o m e a c h m e di c al c e nt er.

T hi s st u d y will b e c o n d u ct e d a n d s p o n s or e d b y t h e D e p art m e nt of V et er a n s Aff air s.
D U R A TI O N O F T H E R E S E A R C H   
T h e e ntir e st u d y will l a st a b o ut 3 . 5 y e ar s. Y o u will b e i n t h e st u d y a b o ut 3 9  w e e k s. 
S T U D Y P R O C E D U R E S 
If y o u d e ci d e t o t a k e p art i n t hi s st u d y, t hi s i s w h at will h a p p e n.  T hi s st u d y h a s 3  p h a s e s: 
s cr e e ni n g ( 2-4  w e e k s) , i nt er v e nti o n ( 4 - 1 1 w e e k s) , a n d f oll o w- u p ( 24  w e e k s) .  
1. S C R E E NI N G P H A S E
If y o u a gr e e t o b e i n t hi s st u d y, y o u will c o m pl et e a n u m b er of t e st s t o m a k e s ur e t h at y o u ar e 
h e alt h y e n o u g h.  Y o u will r e a d  a n d si g n t hi s i nf or m e d c o n s e nt f or m b ef or e y o u b e gi n t h e 
s cr e e ni n g p h a s e.  T h e s cr e e ni n g p h a s e will t a k e 7  t o 8  h o ur s t o c o m pl et e.  It m a y b e d o n e i n 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 3 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
o n e d a y or o v er s e v er al d a y s.  T h e s cr e e ni n g p h a s e will l a st b et w e e n 2 a n d 4  w e e k s aft er 
si g ni n g t h e i nf or m e d c o n s e nt f or m. 
D uri n g t h e s cr e e ni n g p h a s e a n d b ef or e y o u ar e gi v e n a n y r T M S tr e at m e nt s, t h e f oll o wi n g will 
h a p p e n:  
 
  
Y o u will b e gi v e n a p h y si c al ex a mi n ati o n.  A cli ni ci a n will a s s e s s y o ur m e di c al hi st or y, 
a n d will a s k q u e sti o n s a b o ut y o ur m e nt al h e alt h, y o ur i n c o m e a n d li vi n g sit u ati o n, y o ur 
m o o d, y o ur c urr e nt d e pr e s si v e s y m pt o m s a n d a n y f e eli n g s or t h o u g ht s of s ui ci d e. 
  
St u d y st aff will r e vi e w wit h y o u a n y dr u g s ( pr e s cri pti o n s, “ n at ur al f o o d pr o d u ct s” a n d 
“ o v er t h e c o u nt er”) t h at y o u are t a ki n g or h a v e t a k e n i n t h e p a st.  D uri n g t h e st u d y, y o u 
will n ot b e a bl e t o t a k e a n y dr u g s k n o w n t o gr e atl y i n cr e a s e t h e ri s k of s eiz ur e s. Y o ur 
pri m ar y V A p s y c hi atri st will a dj u st y o ur dr u g s a s n e e d e d.  
  
Y o u will c o m pl et e s e v er al s elf- a s s e s s m e nt s a b o ut y o ur m o o d ( i n cl u di n g t h o u g ht s of 
s ui ci d e) , y o ur h e alt h, y o ur u s e of al c o h ol a n d ot h er s u b st a n c e s, a n d a n y p o s si bl e 
tr a u m ati c ex p eri e n c e s y o u m a y h a v e h a d.   
 
Y o u will w or k wit h st u d y st aff a n d y o ur tr e at m e nt t e a m t o c o m pl et e a s ui ci d e s af et y pl a n 
pri or t o e nr olli n g i n t h e st u d y.  T hi s i s r eq uir e d of all p arti ci p a nt s.  
  
A bl o o d s a m pl e will b e t a k e n t o c h e c k h o w v ari o u s s y st e m s i n y o ur b o d y, li k e y o ur li v er 
a n d ki d n e y s, ar e w or ki n g.  T h e t ot al a m o u nt of bl o o d i n t h e s a m pl e will eq u al a b o ut 4  
t a bl e s p o o n s.   
  If y o u h a v e a li v er f u n cti o n t e st t h at i s a b n or m al, y o u m a y n e e d t o r et ur n f or a d diti o n al 
t e st s. 
  
Y o u will b e a s k e d t o pr o vi d e a uri n e s a m pl e.  T hi s s a m pl e will b e s cr e e n e d f or t h e u s e of 
dr u g s.  Y o ur uri n e s cr e e n r e s ult s will n ot b e di s cl o s e d t o a n y o n e o ut si d e t hi s st u d y b ut 
p o siti v e r e s ult s m a y r eq uir e t h at y o u b e ex cl u d e d fr o m t hi s st u d y.  If y o u ar e a bl e t o st o p 
u si n g t h e s e dr u g s, y o u m a y b e r e- s cr e e n e d l at er. 
  
Y o u will h a v e a n al c o h ol t e st t o m e a s ur e y o ur bl o o d al c o h ol l e v el.  T hi s will b e f or t h e 
s cr e e ni n g of al c o h ol u s e.  Y o ur r e s ult s will n ot b e di s cl o s e d t o a n y o n e o ut si d e t hi s st u d y 
b ut p o siti v e r e s ult s m a y r eq uir e t h at y o u b e ex cl u d e d fr o m t hi s st u d y.  If y o u ar e a bl e t o 
li mit y o ur al c o h ol c o n s u m pti o n, y o u m a y b e r e- s cr e e n e d l at er.  
  
Y o u will b e pr o vi d e d wit h t h e r e s ult s of t h e s e bl o o d, uri n e, a n d al c o h ol t e st s, if y o u 
r eq u e st t h e m. 
 
Y o u will b e t e st e d wit h a n r T M S c oil i n or d er t o fi n d t h e s etti n g s t h at will b e u s e d f or y o ur 
tr e at m e nt s.  T hi s i s c all e d a “ m ot or t hr e s h ol d” a n d i s t h e a mo u nt of m a g n eti c p o w er 
r eq uir e d t o m a k e y o ur ri g ht t h u m b m o v e b y sti m ul ati n g y o ur br ai n.  W 
e will att a c h p a d s 
t o y o ur ri g ht t h u m b a n d h a n d wit h t a p e a n d n o n- p er m a n e nt sti c k y gl u e.  T h e p a d s will b e 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 4 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
c o n n e ct e d t o a m a c hi n e w hi c h m e a s ur e s t h e m o v e m e nt i n y o ur h a n d.  W 
e will u s e t hi s 
m a c hi n e, c all e d a n el e ctr o m y o gr a p h or E  MG , t o fi n d y o ur m ot or t hr e s h ol d.  
 
2. I N T E R V E N TI O N P H A S E   
 
If y o u a gr e e a n d ar e eli gi bl e t o p arti ci p at e i n t hi s r e s e ar c h st u d y, y o u will b e e nr oll e d i n t h e 
i nt er v e nti o n p h a s e of t h e st u d y.  T hi s p h a s e will l a st u p t o 1 1 w e e k s.  Y o u will c o m e t o t h e 
cli ni c f or 2 0 t o 3 0 s e s si o n s t o r e c ei v e y o ur r T M S tr e at m e nt s.  E a c h s e s si o n will l a st ar o u n d 
o n e h o ur.  2 5  mi n ut e s will c o n si st of t h e a ct u al r T M S tr e at m e nt.  T h er e will n or m all y b e fi v e 
d ail y s e s si o n s p er w e e k, M o n d a y t hr o u g h Fri d a y. Aft er e v er y fift h tr e at m e nt, y o u will m e et 
wit h st u d y st aff t o c o m pl et e st u d y a s s e s s m e nt s t h at will l a st u p t o a n a d diti o n al h o ur.  Aft er 
t h e 2 0t h s e s si o n, y o u will b e e v al u at e d t o d et er mi n e if t h er e h a s b e e n a n y i m pr o v e m e nt i n 
y o ur d e pr e s si o n.  T hi s will d et er mi n e if a n y f ut ur e s e s si o n s ar e n e e d e d.  If y o u n e e d 
a d diti o n al s e s si o n s, y o u will r e c ei v e eit h er fi v e or t e n a d diti o n al s e s si o n s.  Y o ur fi n al s e s si o n 
will r eq uir e ar o u n d 4  h o ur s.   
   
D uri n g t h e i nt er v e nti o n p h a s e, t h e f oll o wi n g will h a p p e n: 
 
  
Y o u will b e r a n d o miz e d t o eit h er a cti v e “r e al r T M S” tr e at m e nt or t o s h a m tr e at m e nt.  I n 
a cti v e tr e at m e nt “r e al r T M S”, bri ef p ul s e s of m a g n eti c e n er g y ar e u s e d t o sti m ul at e n er v e 
c ell s i n y o ur br ai n.  I n s h a m tr e at m e nt, t h e s a m e m a c hi n e i s u s e d b ut t h e n er v e c ell s ar e 
n ot sti m ul at e d.  R a n d o miz ati o n i s a pr o c e s s t h at i s si mil ar t o fli p pi n g a c oi n w h er e o n e 
si d e of t h e c oi n i s a cti v e a n d t h e ot h er si d e i s s h a m.  It i s al s o si mil ar t o dr a wi n g a pi e c e 
of p a p er o ut of a h at w h er e s o m e pi e c e s s a y a cti v e a n d ot h er s s a y s h a m.  T h er e i s a 
5 0: 5 0 c h a n c e of b ei n g r a n d o miz e d t o eit h er tr e at m e nt gr o u p. 
 
 
All p ati e nt s, r e g ar dl e s s of w h et h er t h e y ar e g etti n g a cti v e or s h a m T M S, will h a v e mil d 
el e ctri c al p a d s pl a c e d o n t h e s ki n j u st u n d er n e at h t h e T M S c oil. D uri n g t h e T M S, t h er e 
will b e a sli g ht el e ctri c al c urr e nt p a s si n g t hr o u g h t h e s e p a d s, w hi c h will pr o d u c e a mil d 
ti n gli n g s e n s ati o n.  T h e p ur p o s e of t hi s ti n gli n g i s t o m a k e it h ar d t o t ell w h et h er y o u ar e 
g etti n g t h e a cti v e or s h a m T M S.  
 
 N eit h er y o u n or y o ur st u d y d o ct or will k n o w w hi c h tr e at m e nt y o u ar e g etti n g u ntil t h e 
st u d y i s o v er.  T hi s t y p e of st u d y i s c all e d a d o u bl e bli n d tri al a n d t hi s st u d y t y p e i s b ei n g 
u s e d s o t h at y o ur tr e at m e nt a n d e v al u ati o n w o n’t b e aff e ct e d b y s o m e o n e k n o wi n g 
w h et h er or n ot y o u ar e g etti n g a cti v e “r e al r T M S” or s h a m tr e at m e nt.  T h e st u d y m a c hi n e 
will k n o w w hi c h tr e at m e nt y o u ar e g etti n g s o t h at y o u will r e c ei v e t h e s a m e tr e at m e nt at 
e a c h vi sit.  If y o ur st u d y d o ct or n e e d s t o k n o w w hi c h tr e at m e nt y o u ar e g etti n g, h e or s h e 
will b e a bl e t o g et t h at i nf or m ati o n. 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 5 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
 
   B ef or e t h e fir st tr e at m e nt, w e will a s k y o u w h et h er y o u b eli e v e y o u will r e c ei v e t h e 
a cti v e “r e al r T M S” or t h e s h a m ( i n a cti v e)  tr e at m e nt.  Aft er t h e fir st tr e at m e nt, w e will a s k 
y o u w h et h er y o u b eli e v e y o u r e c ei v e d t h e a cti v e “r e al r T M S” or t h e s h a m tr e at m e nt. 
 
  
Y o u will b e r et e st e d t o fi n d y o ur m ot or t hr e s h ol d o n t h e fir st d a y of e a c h of t h e 5- s e s si o n 
bl o c k s.  Y o u will b e t e st e d wit h a n a cti v e c oil t o fi n d t h e s etti n g s t h at will b e u s e d f or y o u.   
 
  
Y o u will b e a s k e d a b o ut a n y ot h er dr u g s t h at y o u ar e t a ki n g a n d a b o ut si d e eff e ct s t h at 
m a y h a v e o c c urr e d si n c e y o ur l a st vi sit.  T h e s e m a y or m a y n ot b e r el at e d t o t h e st u d y 
tr e at m e nt.  Y o u will al s o b e a s k e d a b o ut t h e a m o u nt of al c o h ol or ot h er s u b st a n c e s y o u 
h a v e c o n s u m e d si n c e y o ur l a st vi sit.  T h e s e q u e sti o n s will b e a s k e d at e v er y s e s si o n. 
 
  
Y o u will b e a s k e d t o pr o vi d e a uri n e s a m pl e s e v er al ti m e s r a n d o ml y d uri n g t hi s p h a s e.  
T hi s s a m pl e will b e s cr e e n e d f or t h e u s e of dr u g s.  Y o ur uri n e s cr e e n r e s ult s m a y b e 
di s cl o s e d t o y o ur pri m ar y m e nt al h e alt h pr o vi d er if w e t hi n k t h at y o u ar e u si n g i n a ri s k y 
m a n n er.  Y o u m a y al s o n ot b e all o w e d t o r e c ei v e y o ur r T M S tr e at m e nt. 
 
  
Y o u will h a v e a n al c o h ol t e st t o d et er mi n e y o ur bl o o d al c o h ol l e v el s e v er al ti m e s 
r a n d o ml y d uri n g t hi s p h a s e.  T hi s will b e f or t h e s cr e e ni n g of al c o h ol u s e.  Y o ur r e s ult s 
m a y b e di s cl o s e d t o y o ur pri m ar y m e nt al h e alt h pr o vi d er if w e t hi n k t h at y o u ar e u si n g 
al c o h ol i n a ri s k y m a n n er.  Y o u m a y al s o n ot b e all o w e d t o r e c ei v e y o ur r T M S tr e at m e nt. 
 
  
Y o u will b e a s k e d a b o ut y o ur p h y si c al a n d m e nt al h e alt h, y o ur u s e of al c o h ol a n d ot h er 
dr u g s, y o ur m o o d, y o ur c urr e nt d e pr e s si v e s y m pt o m s a n d a n y t h o u g ht s or f e eli n g s of 
s ui ci d e. 
 
  
Y o u will c o m pl et e s e v er al s elf- a s s e s s m e nt s a b o ut h o w y o u ar e f e eli n g aft er e v er y 5t h 
s e s si o n. 
 
T h e f oll o wi n g i s a d e s cri pti o n of t h e st u d y pr o c e d ur e:  
  
Y o u will b e a w a k e a n d al ert t hr o u g h o ut t h e tr e at m e nt s e s si o n.  
 
  
Y o u will b e s e at e d i n a c h air.  Y o u will b e pr o vi d e d wit h e ar pr ot e cti o n.  Y o ur h e a d will b e 
pl a c e d i n a h ol d er s o t h at it i s c orr e ctl y p o siti o n e d.  Y o u m a y cl o s e y o ur e y e s d uri n g 
tr e at m e nt b u t n ot f all a sl e e p. 
  

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 6 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
  
A m et al c oil i n a pl a sti c c a s e will b e h el d a g ai n st t h e s c al p o n t h e l eft si d e of y o ur h e a d.  
Y o u will h e ar a cli c ki n g n oi s e a s a f e w m a g n eti c p ul s e s ar e pr o d u c e d.  T h e a d mi ni str at or 
will u s e t h e c oil t o fi n d t h e ar e a i n y o ur br ai n t h at c a u s e s y o ur ri g ht t h u m b t o m o v e.   T hi s 
i s c all e d t h e M ot or T hr e s h ol d (  M T) . 
 
  
P arti ci p a nt s n or m all y n oti c e o nl y a l o u d cli c ki n g n oi s e, a n d ti n gli n g s e n s ati o n o n t h e 
s c al p.   T h e c oil m a y f e el w ar m or h ot a g ai n st y o ur h e a d. 
   
   D e p e n di n g o n t h e tr e at m e nt gr o u p t h at y o u h a v e b e e n a s si g n e d t o, y o u will r e c ei v e 
eit h er a cti v e “r e al r T M S” or s h a m ( i n a cti v e)  tr e at m e nt s. 
 
  
Y o u m a y dri v e y o ur s elf t o a n d fr o m tr e at m e nt s e s si o n s a n d att e n d t o y o ur n or m al d ail y 
t a s k s. 
 
3. F O L L O W- U P P H A S E 
 
Aft er t h e i nt er v e nti o n p h a s e of t h e st u d y, y o u will e nt er a 24
- w e e k f oll o w- u p p h a s e.  If y o ur 
d e pr e s si o n h a s si g nifi c a ntl y i m pr o v e d d uri n g t h e i nt er v e nti o n p h a s e, y o u will r e c ei v e 6 
a d diti o n al tr e at m e nt s e s si o n s d uri n g t h e fir st t hr e e w e e k s ( 3  d uri n g t h e fir st w e e k, 2 d uri n g 
t h e s e c o n d, a n d 1 d uri n g t h e t hir d)  of t h e f oll o w- u p p h a s e.  D uri n g t h e f oll o w- u p p h a s e, y o u 
will m e et wit h st u d y st aff t o c o m pl et e st u d y a s s e s s m e nt s.  T h e a m o u nt of ti m e r eq uir e d t o 
c o m pl et e e a c h m o nt hl y vi sit ( t e sti n g a n d e v al u ati o n)  s h o ul d b e ar o u n d 1 h o ur.  T h e fi n al 
f oll o w- u p vi sit will t a k e a b o ut 4  t o 5 h o ur s.  If y o u ar e u n a bl e t o c o m e i n f or a f a c e t o f a c e 
f oll o w- u p vi sit, t el e p h o n e vi sit s m a y b e arr a n g e d. 
 
D uri n g t h e 24 - w e e k f oll o w- u p p h a s e, t h e f oll o wi n g will h a p p e n:  
 
  
St u d y st aff will a s k y o u a b o ut t h e f oll o wi n g: 
  
A n y dr u g s t h at y o u ar e t a ki n g a n d si d e eff e ct s t h at m a y h a v e o c c urr e d si n c e y o ur 
  
l a st vi sit.   
 
  
Y o ur p h y si c al a n d m e nt al h e alt h, y o ur m o o d a n d y o ur c urr e nt d e pr e s si v e 
 s y m pt o m s.
 
 
  
A n y t h o u g ht s or f e eli n g s of s ui ci d e. 
 
  
Y o u will c o m pl et e s e v er al s elf- a s s e s s m e nt s a b o ut y o ur m o o d, y o ur h e alt h, a n d a n y 
p o s si bl e tr a u m ati c ex p eri e n c e s y o u m a y h a v e h a d. 
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 7 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
  
Y o u will b e a s k e d t o pr o vi d e a uri n e s a m pl e s e v er al ti m e s d uri n g t hi s p h a s e.  T hi s 
s a m pl e will b e s cr e e n e d f or t h e u s e of dr u g s.  Y o ur uri n e s cr e e n r e s ult s m a y b e 
di s cl o s e d t o y o ur pri m ar y m e nt al h e alt h pr o vi d er if w e t hi n k t h at y o u ar e u si n g dr u g s i n a 
ris k y m a n n er.   
 
  
Y o u will h a v e a n al c o h ol t e st t o d et er mi n e y o ur bl o o d al c o h ol l e v el s e v er al ti m e s d uri n g 
t hi s p h a s e.  T hi s will b e f or t h e s cr e e ni n g of al c o h ol u s e.  Y o ur r e s ult s m a y b e di s cl o s e d 
t o y o ur pri m ar y m e nt al h e alt h pr o vi d er if w e t hi n k t h at y o u ar e u si n g al c o h ol i n a ri s k y 
m a n n er. 
 
  
At y o ur fi n al f oll o w- u p vi sit, w e will a s k y o u w h et h er y o u b eli e v e y o u r e c ei v e d t h e a cti v e 
“r e al r T M S” or t h e s h a m tr e at m e nt. 
 
4. F O R A L L S T U D Y P H A S E S 
 
  
Sl e e p i s fr eq u e ntl y di sr u pt e d w h e n p e o pl e ar e d e pr e s s e d.  W 
e r e c o g niz e t h at y o u m a y 
h a v e tr o u bl e sl e e pi n g.  It i s i m p ort a nt f or t h e tr e at m e nt t e a m t o m o nit or t h e a m o u nt of 
sl e e p y o u g et pri or t o e a c h tr e at m e nt s e s si o n.  If st u d y st aff b eli e v e s t h at y o u h a v e n ot 
g ott e n a d eq u at e sl e e p, t h e y m a y c a n c el or r e s c h e d ul e t h at s e s si o n. 
 
 
It i s i m p ort a nt f or st u d y st aff t o b e a w ar e of a n y c h a n g e s i n y o ur m e di c ati o n s d uri n g y o ur 
p arti ci p ati o n i n t h e st u d y.  If t h er e ar e c h a n g e s t o y o ur m e di c ati o n s or y o u t a k e t h e m n ot 
a s pr e s cri b e d pri or t o a tr e at m e nt s e s si o n, st u d y st aff m a y c h o o s e t o c a n c el or 
r e s c h e d ul e t h at s e s si o n. 
 
 
Y o u will i nt er a ct wit h m e m b er s of t h e e ntir e st u d y t e a m.  T hi s i n cl u d e s a p s y c hi atri st or 
n e ur ol o gi st, a n ur s e or p h y si ci a n a s si st a nt r T M S O p er at or, a n d a St u d y C o or di n at or.  
T h e st u d y t a k e s pl a c e at t h e ( i n s ert sit e n a m e)  d uri n g n or m al b u si n e s s h o ur s, M o n d a y 
t hr o u g h Fri d a y, 8 a m t o 4 :3 0 p m.  If a s k e d, w e will pr o vi d e a n ot e f or y o ur e m pl o y er t h at 
y o u w er e r e c ei vi n g m e di c al tr e at m e nt.   W 
e will n ot c o m p e n s at e f or mi s s e d w or k ti m e. 
 
  
Y o u will b e a s k e d a b o ut a d v er s e e v e nt s w h e n e v er y o u ar e s e e n b y st u d y st aff f or 
tr e at m e nt, e v al u ati o n, a n d f oll o w- u p vi sit s.  A n a d v er s e e v e nt i s a n yt hi n g b a d t h at 
h a p p e n s wit h y o u a n d m a y or m a y n ot b e r el at e d t o y o ur p arti ci p ati o n i n t hi s st u d y.  A n 
i n d e p e n d e nt c o m mitt e e will b e t ol d a b o ut all a d v er s e e v e nt s at l e a st o n c e e v er y six  
m o nt h s.  If t h e y b eli e v e t h at a n y a s p e ct of t hi s st u d y i s u n s af e, t h e y will r e c o m m e n d t h at 
c h a n g e s b e m a d e t o eli mi n at e t h e s af et y pr o bl e m.  
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 8 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
R E S P O N SI BI LI TI E S A N D E X P E C T A TI O N S O F S T U D Y P A R TI CI P A N T S 
 
I n or d er t o m ax i miz e t h e p o s si bl e b e n efit s of t h e r T M S tr e at m e nt a n d t o b e st e n s ur e t h e 
s af et y of st u d y p arti ci p a nt s, w e will n o w g o o v er t h e r e s p o n si biliti e s a n d ex p e ct ati o n s of 
p arti ci p ati o n. 
 
  
C o m pl et e y o ur q u e sti o n n air e s a s i n str u ct e d.  Y o u ar e fr e e t o s ki p a n y q u e sti o n s t h at y o u 
pr ef er n ot t o a n s w er. 
 
  
A s k q u e sti o n s a s y o u t hi n k of t h e m. 
 
  T ell t h e i n v e sti g at or or r e s e ar c h st u d y st aff if y o u t hi n k y o u mi g ht b e pr e g n a nt. 
 
  T ell t h e i n v e sti g at or or r e s e ar c h st aff if y o u c h a n g e y o ur mi n d a b o ut st a yi n g i n t h e st u d y. 
 
 
W 
hil e p arti ci p ati n g i n t hi s r e s e ar c h st u d y, d o n ot t a k e p art i n a n y ot h er r e s e ar c h st u d y 
wit h o ut a p pr o v al fr o m t h e i n v e sti g at or s.  T hi s i s t o pr ot e ct y o u fr o m p o s si bl e i nj ur y fr o m 
t hi n g s s u c h a s ex tr a bl o o d dr a wi n g or p ot e nti al dr u g i nt er a cti o n s.  T a ki n g p art i n ot h er 
r e s e ar c h st u di e s wit h o ut a p pr o v al fr o m t h e i n v e sti g at or s m a y i n v ali d at e t h e r e s ult s of t hi s 
r e s e ar c h, a s w ell a s t h at of t h e ot h er st u di e s. 
 
 K e e p y o ur st u d y a p p oi nt m e nt s.  If it i s n e c e s s ar y t o mi s s a n a p p oi nt m e nt, pl e a s e c o nt a ct 
t h e i n v e sti g at or or st u d y st aff t o r e s c h e d ul e a s s o o n a s y o u k n o w y o u will mi s s t h e 
a p p oi nt m e nt. 
 
  It i s i m p ort a nt t h at y o u n ot gi v e f al s e, i n c o m pl et e, or mi sl e a di n g i nf or m ati o n a b o ut 
y o ur m e di c al hi st or y, i n cl u di n g p a st a n d pr e s e nt dr u g u s e, b e c a u s e t hi s c o ul d h a v e 
s eri o u s c o n s eq u e n c e s f or y o ur w ell- b ei n g.   
 
  T h e eff e ct s of al c o h ol a n d s u b st a n c e u s e w hil e u n d er g oi n g r T M S ar e n ot w ell k n o w n at 
t hi s ti m e.  Al c o h ol u s e will b e li mit e d t o 1 al c o h oli c b e v er a g e, d efi n e d a s 1 2 oz . b e er, 5 
oz . wi n e, or 1. 5 oz . h ar d liq u or, a d a y.  Y o u c a nn o t u s e ill e g al s u b st a n c e s, s u c h a s 
m arij u a n a, c o c ai n e, a n d a m p h et a mi n e s, d uri n g y o ur p arti ci p ati o n i n t h e st u d y.  If y o u 
b e gi n t o u s e s u b st a n c e s i n a ri s k y m a n n er d uri n g y o ur p arti ci p ati o n i n t hi s tri al, st u d y 
st aff will n otif y y o ur pri m ar y V A p s y c hi atri st a n d y o u m a y b e r e m o v e d fr o m t h e st u d y.  If 
y o u r e p ort c o n s u mi n g m or e t h a n o n e al c o h oli c b e v er a g e or u si n g s u b st a n c e s pri or t o 
y o ur tr e at m e nt s e s si o n, st u d y st aff m a y c h o o s e t o c a n c el or r e s c h e d ul e t h at s e s si o n. 
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 9 of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
P O S SI B L E RI S K S O R DI S C O M F O R T S 
 
A n y pr o c e d ur e h a s p o s si bl e ri s k s a n d di s c o mf ort s .  T h e pr o c e d ur e s i n t hi s st u d y m a y c a u s e all, 
s o m e or n o n e of t h e ri s k s or  si d e eff e ct s li st e d.  R ar e, u n k n o w n, or u nf or e s e e a bl e 
( u n a nti ci p at e d)  ri s k s al s o m a y o c c ur. Y o u n e e d t o c ar ef ull y c o n si d er t h e f oll o wi n g:    
T h e dr a wi n g of bl o o d m a y c a u s e p ai n, bl e e di n g, br ui si n g, f e eli n g f ai nt a n d, o n r ar e o c c a si o n s, 
i nf e cti o n at t h e sit e of t h e n e e dl e i n s erti o n.  Pr e c a uti o n s will b e t a k e n t o mi ni miz e t h e s e ri s k s.  
T h e t ot al a m o u nt of bl o o d t h at y o u will b e a s k e d t o gi v e d uri n g t h e st u d y i s a b o ut 4  t a bl e s p o o n s. 
 
If y o u ar e t a ki n g a n y dr u g s t h at m a y i n cr e a s e t h e ri s k of h a vi n g a s eiz ur e, y o u will n e e d t o b e 
t a k e n off t h o s e dr u g s b ef or e y o u c a n p arti ci p at e.  Y o u a n d y o ur p h y si ci a n will n e e d t o di s c u s s 
t h e f e a si bilit y of y o ur di s c o nti n ui n g a n y s u c h m e di c ati o n. W it h dr a w al fr o m s u c h dr u g s m a y 
c a u s e di s c o mf ort or ill n e s s.  
  
A f e w p ati e nt s r e c ei vi n g r T M S h a v e h a d s eiz ur e s.  All of t h e r e p ort e d s eiz ur e s r e s ol v e d 
pr o m ptl y o n t h eir o w n a n d n o n e h a d a n y l a sti n g eff e ct s or a d v er s e i m p a ct o n t h e p ati e nt s.  
T h er e i s littl e e vi d e n c e of ri s k of s eiz ur e s u si n g r T M S t h e w a y it will b e u s e d i n t hi s st u d y.    
 
T h er e m a y b e a n i n cr e a s e d ri s k of s eiz ur e s fr o m c o m bi ni n g t h e u s e of b u pr o pi o n a n d r T M S. 
 
I n t h e u nli k el y e v e nt t h at a s eiz ur e d o e s o c c ur, y o u will b e cl o s el y m o nit or e d a n d tr e at e d f or a n y 
m e di c al or p s y c h ol o gi c al c o n s eq u e n c e s.  L a b t e st s will b e dr a w n a n d y o u will b e s e e n b y a 
n e ur ol o gi st a s s o o n a s p o s si bl e.  T h e r o o m s w h er e t h e r T M S st u di e s ar e p erf or m e d ar e f ull y 
eq ui p p e d t o s af el y h a n dl e a s eiz ur e.  Aft er t h e n e ur ol o gi st h a s s e e n y o u a n d d et er mi n e d w h at 
c a u s e d y o ur s eiz ur e, y o u will b e gi v e n a l ett er r e g ar di n g t h e s eiz ur e t o s h ar e wit h y o ur pri m ar y 
h e alt h c ar e pr o vi d er.  If y o u h a v e n o ot h er m e di c al or n e ur ol o gi c al pr o bl e m t h at c a u s e d t h e 
s eiz ur e, t h e l ett er will i n di c at e t h at t h e s eiz ur e d uri n g r T M S d o e s n ot i n cr e a s e y o ur ri s k f or f ut ur e 
s eiz ur e s. 
 
r T M S tr e at m e nt c a n r e s ult i n mil d t o m o d er at e h e a d a c h e s i n a s m a n y a s 3 0 o ut of 1 0 0 of 
p ati e nt s.  S o m e p e o pl e al s o r e p ort di s c o mf ort at t h e sit e of r T M S sti m ul ati o n.  T hi s o c c ur s i n 
ar o u n d 1 5 o ut of 1 0 0 of p ati e nt s.  H e a d a c h e s a n d sit e di s c o mf ort u s u all y r e a dil y r e s p o n d t o 
a c et a mi n o p h e n or i b u pr of e n.  P ai nf ul n e s s i m pr o v e s o v er ti m e or g o e s a w a y.  O ft e n p ati e nt s f all 
a sl e e p i n t h e s e c o n d w e e k w hil e r e c ei vi n g t h e s a m e tr e at m e nt t h at o n t h e fir st d a y w a s r e p ort e d 
a s v er y p ai nf ul. 
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 0  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
T h er e i s a s m all ri s k of d e nt al p ai n wit h r T M S, d uri n g or i m m e di at el y aft er t h e tr e at m e nt.  If t hi s 
o c c ur s, l et y o ur st u d y d o ct or s a n d n ur s e s k n o w a n d t h e y m a y b e a bl e t o m o v e t h e r T M S c oil 
p o siti o n or pr o vi d e y o u wit h a bit e bl o c k t o r e d u c e t hi s p ai n or m a k e it n ot h a p p e n.  
 
r T M S tr e at m e nt m a y pr o d u c e m o v e m e nt or ti n gli n g of t h e ar m, l e g, f a c e or s c al p.  Y o u m a y al s o 
ex p eri e n c e a t e m p or ar y f e eli n g of n u m b n e s s i n t h e f a c e.   
 
D uri n g tr e at m e nt t h e c oil m a y g et w ar m.  It m a y f e el a b o ut t h e s a m e a s a h e ati n g p a d o n l o w or 
m e di u m s etti n g. T hi s m a y b e u n c o mf ort a bl e b ut s h o ul d n ot b e p ai nf ul. 
 
T h er e i s a p o s si bl e ri s k of h e ari n g l o s s d u e t o t h e s o u n d s m a d e b y t h e d e vi c e.  Y o u will w e ar 
e ar pl u g s a n d h e a d p h o n e s d uri n g y o ur r T M S s e s si o n s.  T hi s s h o ul d gr e atl y r e d u c e t h e 
p o s si bilit y of h e ari n g l o s s.  If y o u t hi n k y o ur h e ari n g i s g etti n g w or s e d uri n g t h e st u d y, t ell t h e 
st u d y t e a m ri g ht a w a y.  Aft er y o ur l a st st u d y tr e at m e nt, y o u m a y k e e p t h e h e a d p h o n e s if y o u 
c h o o s e. 
 
T h e r T M S o p er at or will m o nit or y o u f or e ar pr ot e cti o n, c oil pl a c e m e nt, a n d s eiz ur e a cti vit y d uri n g 
all s e s si o n s. 
 
I n s o m e p e o pl e, d ail y pr efr o nt al r T M S c a n c a u s e t h e m t o h a v e i n cr e a s e d e n er g y, n o n e e d f or 
sl e e p, a n d r a pi d r a ci n g t h o u g ht s.  T hi s i s c all e d m a ni a.  If y o u n oti c e t h e s e c h a n g e s l et y o ur 
pri m ar y m e nt al h e alt h pr o vi d er a n d st u d y t e a m k n o w. 
 
A m aj or ri s k i n tr e ati n g s eri o u sl y d e pr e s s e d p ati e nt s i s t h e ri s k of s ui ci d e.  W e will w or k wit h y o u 
a n d y o ur pri m ar y m e nt al h e alt h pr o vi d er i n t h e cr e ati o n of a writt e n s af et y pl a n pri or t o y o ur 
p arti ci p ati o n i n t h e st u d y.  O n e p art of t h e s af et y pl a n m a y b e t h e r e q uir e m e nt t h at all fir e ar m s 
eit h er b e r e m o v e d fr o m y o ur r e si d e n c e or b e pl a c e d u n d er l o c k a n d k e y, i n cl u di n g tri g g er l o c k s, 
wit h g u n s a n d a m m u niti o n l o c k e d s e p ar at el y a n d t h e k e y s gi v e n t o a n ot h er f a mil y m e m b er or 
fri e n d. 
   
Y o u will fr e q u e ntl y b e a s k e d a b o ut “ s ui ci d al t h o u g ht s” d uri n g t h e st u d y.  T hi s i s n ot b e c a u s e w e 
t hi n k t h e tr e at m e nt will m a k e y o u s ui ci d al, b ut r at h er b e c a u s e w e k n o w t h at y o u ar e d e pr e s s e d 
a n d m a n y d e pr e s s e d p e o pl e t hi n k of s ui ci d e.   Pl e a s e gi v e h o n e st a n d o p e n a n s w er s t o s u c h 
q u e sti o n s a n d w e will tr y t o h el p y o u g et o v er a n y s u c h f e eli n g s.  A n d b e c a u s e t hi s i s s u c h a n 
i m p ort a nt i s s u e, if y o u h a v e a n y s ui ci d al t h o u g ht s, it i s vit al t h at y o u s e e k a p pr o pri at e c ar e 
i m m e di at el y.  A n a ct u al s ui ci d e att e m pt will r e s ult i n n ot b ei n g a bl e t o c o nti n u e st u d y tr e at m e nt s 
a n d y o u will i m m e di at el y e nt er t h e 24  w e e k s ( 6 m o nt h)  f oll o w- u p p h a s e. 
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 1  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
Y o ur st u d y i n v e sti g at or will b e m o nit ori n g y o u d uri n g y o ur p arti ci p ati o n t o s e e if y o u ar e 
ex p eri e n ci n g a n y si d e eff e ct s.  It i s i m p ort a nt t h at y o u r e p ort pr o m ptl y a n y si d e eff e ct t o st u d y 
st aff.  If y o u f e el, or y o ur st u d y i n v e sti g at or f e el s, t h at t h e si d e eff e ct s ar e n ot w ell t ol er at e d, 
tr e at m e nt m a y b e st o p p e d alt o g et h er a n d y o u m a y b e wit h dr a w n fr o m t h e st u d y.   
 
T h e  p o s si bilit y of l o n g-t er m ri s k s i s u n k n o w n.  I n pr e vi o u s st u di e s, a ni m al a n d h u m a n br ai n s 
h a v e s h o w n n o e vi d e n c e of a n y ki n d of d a m a g e fr o m r T M S.  A s wit h a n y ex p eri m e nt al 
tr e at m e nt, t h er e m a y b e u nf or e s e e n ri s k s a s s o ci at e d wit h t hi s d e vi c e.  Y o u will b e i nf or m e d of 
a n y n e w i nf or m ati o n t h at i s d e v el o p e d d uri n g t h e st u d y t h at mi g ht aff e ct y o ur willi n g n e s s t o 
c o nti n u e y o ur p arti ci p ati o n. 
 
Y o u will al s o b e e v al u at e d f or c urr e nt a n d pr e vi o u s m e di c al a n d p s y c hi atri c di a g n o s e s.   Y o u 
will b e a s k e d t o r e p ort y o ur u s e of al c o h ol a n d ot h er s u b st a n c e s ( m arij u a n a, c o c ai n e, h er oi n, 
et c).  Y o u will al s o b e a s k e d t o c o m pl et e q u e sti o n n air e s t h at a s k a b o ut y o ur lif e s ati sf a cti o n, 
q u alit y of lif e, w or k, s ui ci d e i d e ati o n a n d ot h er a s p e ct s of y o ur lif e, a s w ell a s a n i nt er vi e w 
a b o ut s y m pt o m s of d e pr e s si o n.  T h e s e q u e sti o n n air e s t a k e ar o u n d 5- 3 0 mi n ut e s e a c h t o 
c o m pl et e (t ot al ti m e, ar o u n d 8 h o ur s).  T h e t y p e, fr e q u e n c y, a n d i nt e n sit y of y o ur m aj or 
d e pr e s si o n s y m pt o m s will b e e v al u at e d d uri n g a 2 h o ur i nt er vi e w.  T h e t ot al ti m e r e q uir e d f or 
c o m pl eti n g q u e sti o n n air e s, a s s e s s m e nt s, a n d i nt er vi e w s i s ar o u n d 5- 1 0  h o ur s a n d will b e 
d o n e o v er s e v er al vi sit s.   T h e s e q u e sti o n s m a y bri n g o n u n c o mf ort a bl e t h o u g ht s, f e eli n g s, 
a n d l e a d t o r e c alli n g tr o u bli n g m e m ori e s. I n s o m e c a s e s t h e s u bj e ct of q u e sti o n s a n d l e n gt h 
m a y c a u s e f ati g u e, di s c o mf ort, a n d/ or b or e d o m.  It i s i m p ort a nt t o r e m e m b er t h at t h e s e 
q u e sti o n s ar e t o b e a n s w er e d at y o ur o w n p a c e.  If y o u f e el a n yt hi n g d e s cri b e d a b o v e l et t h e 
st u d y c o or di n at or k n o w a n d h e/ s h e c a n c o nti n u e t h e q u e sti o n s a n ot h er d a y.   
 
F or W o m e n of C hil d- b e ari n g P ot e nti al  
F or s af et y r e a s o n s, pr e g n a nt w o m e n will n ot b e all o w e d t o p arti ci p at e i n t hi s st u d y.  T hi s i s 
b e c a u s e t h e eff e ct s of r T M S o n a n u n b or n c hil d ar e n ot k n o w n.  T h er e m a y b e u nf or e s e e a bl e 
( u n a nti ci p at e d)  ri s k s t o t h e p arti ci p a nt ( or t o t h e u n b or n c hil d)  if t h e p arti ci p a nt i s pr e g n a nt or 
b e c o m e s pr e g n a nt d uri n g t h e st u d y.  
 
Y o u will h a v e a uri n e pr e g n a n c y t e st wit hi n 7  d a y s pri or t o y o ur st arti n g st u d y tr e at m e nt.  
T h er e aft er, y o u will h a v e a uri n e pr e g n a n c y t e st e v er y f o ur w e e k s t hr o u g h t h e e n d of t h e 
st u d y t o b e s ur e t h at y o u ar e n ot pr e g n a nt. 
 
Y o u m u st a gr e e t o u s e a m e di c all y a c c e pt a bl e f or m of birt h c o ntr ol w hil e p arti ci p ati n g i n 
t h e st u d y. A c c e pt a bl e f or m s of birt h c o ntr ol ar e:  
  
C o m pl et e a b sti n e n c e ( n ot h a vi n g s ex u al i nt er c o ur s e wit h a n y o n e)  

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 2  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
  
A n or al c o ntr a c e pti v e ( birt h c o ntr ol pill s)  
 N or pl a nt
 
 
D e p o- Pr o v er a  
  
A c o n d o m wit h s p er mi ci d e 
  
A c er vi c al c a p wit h s p er mi ci d e 
  
A di a p hr a g m wit h s p er mi ci d e 
  
A n i ntr a ut eri n e d e vi c e 
  
S ur gi c al st eriliz ati o n ( h a vi n g y o ur t u b e s ti e d)  
 
If y o u b e c o m e pr e g n a nt d uri n g t h e i nt er v e nti o n p h a s e of t h e st u d y, y o u will n ot b e a bl e t o 
c o nti n u e t h e st u d y tr e at m e nt s a n d y o u will i m m e di at el y e nt er t h e 24  w e e k ( 6 vi sit s)  f oll o w- u p 
p h a s e.  Y o u will al s o b e r ef err e d t o a W o m e n’ s H e alt h Cli ni c.  If y o u b e c o m e pr e g n a nt d uri n g 
t h e f oll o w- u p p h a s e of t h e st u d y, y o u will c o nti n u e t o c o m e i n f or all r e m ai ni n g f oll o w- u p p h a s e 
vi sit s a n d will c o m pl et e all a s s e s s m e nt s a s y o u n or m all y w o ul d .   
 
If y o u b e c o m e pr e g n a nt at a n y ti m e d uri n g t h e st u d y, y o u will b e a s k e d t o si g n a r el e a s e of 
i nf or m ati o n f or m f or st u d y st aff t o a c c e s s m e di c al r e c or d s t o o bt ai n i nf or m ati o n r e g ar di n g t h e 
o ut c o m e of y o ur pr e g n a n c y.   N o p e di atri c r e c or d s will b e r e vi e w e d.  
 
T h er e i s n o li k el y eff e ct o n s p er m c o u nt or t h e m otilit y of s p er m or ot h er r e pr o d u cti v e ri s k s 
a s s o ci at e d wit h f at h eri n g a c hil d, alt h o u g h t hi s h a s n ot b e e n f or m all y t e st e d i n h u m a n s.  
L i k e wi s e, t h er e ar e n o k n o w n ri s k s o n s p er m a n d o v a ( e g g s) . 
 
R i s k s of t h e u s u al c ar e y o u r e c ei v e ar e n ot ri s k s of t h e r e s e ar c h.  T h e y ar e n ot i n cl u d e d i n t hi s 
c o n s e nt f or m.  Y o u s h o ul d t al k wit h y o ur h e alt h c ar e pr o vi d er s a b o ut ri s k s of u s u al c ar e.    
 
P O T E N TI A L B E N E FI T S 
 
W 
e c a n’t pr o mi s e t h at y o u will g et a n y b e n efit s fr o m t a ki n g p art i n t hi s r e s e ar c h st u d y.  
H o w e v er, p o s si bl e b e n efit s m a y i n cl u d e r eli ef fr o m d e pr e s si o n a n d i m pr o v e m e nt i n q u alit y of 
lif e.  T h e i nf or m ati o n t h at i s o bt ai n e d d uri n g t hi s st u d y m a y b e s ci e ntifi c all y u s ef ul a n d m a y l e a d 
t o gr e at er k n o wl e d g e a b o ut t h e tr e at m e nt of d e pr e s si o n.   
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 3  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
T h e m e di c al t e sti n g d o n e i n t hi s st u d y c o ul d r e v e al a m e di c al c o n diti o n t h at y o u mi g ht n ot h a v e 
pr e vi o u sl y b e e n a w ar e of a n d f or w hi c h y o u m a y n e e d tr e at m e nt.  St u d y st aff will r ef er y o u f or 
a d diti o n al tr e at m e nt if s u c h pr o bl e m s ar e i d e ntifi e d b ut t h e st u d y will n ot p a y f or t h e tr e at m e nt of 
a n y s u c h i d e ntifi e d pr o bl e m s.  
 
A L T E R N A TI V E P R O C E D U R E S 
 
Y o u m a y c h o o s e n ot t o p arti ci p at e i n t hi s st u d y.  If t hi s i s y o ur d e ci si o n, t h er e ar e ot h er c h oi c e s 
i n cl u di n g t h e st a n d ar d tr e at m e nt s pr o vi d e d b y t h e l o c al cli ni c.  Y o ur st u d y i n v e sti g at or or a st u d y 
cli ni ci a n will di s c u s s a n y alt er n ati v e s wit h y o u b ef or e y o u a gr e e t o p arti ci p at e i n t hi s st u d y.  
Alt er n ati v e tr e at m e nt s i n cl u d e t al k t h er a p y, a nti d e pr e s s a nt dr u g s, r T M S tr e at m e nt o ut si d e of t h e 
st u d y, a n d el e ctr o c o n v ul si v e t h er a p y ( E  C T) .  E C T i s a m e di c al tr e at m e nt f or s e v er e m e nt al 
ill n e s s i n w hi c h a s m all, c ar ef ull y c o ntr oll e d a m o u nt of el e ctri cit y i s i ntr o d u c e d i nt o t h e br ai n t o 
c a u s e a s eiz ur e .  It i s al s o k n o w n a s “ el e ctr ot h er a p y” or “ s h o c k t h er a p y”.  Y o u m a y al s o di s c u s s 
t h e s e o pti o n s wit h y o ur d o ct or.  
  
C O N FI D E N TI A LI T Y 
 
A d e s cri pti o n of t hi s cli ni c al tri al will b e a v ail a bl e o n htt p:/ /  w w w. Cli ni c al Tri al s. g o v  a s r eq uir e d b y 
U . S. L a w.  T hi s W 
e b sit e will n ot i n cl u d e i nf or m ati o n t h at c a n i d e ntif y y o u.  At m o st, t h e W 
e b sit e 
will i n cl u d e a s u m m ar y of t h e r e s ult s.  Y o u c a n s e ar c h t hi s W 
e b sit e at a n y ti m e. 
 
T h e i nf or m ati o n c oll e ct e d f or t hi s st u d y will b e k e pt c o nfi d e nti al.  W 
e will i n cl u d e i nf or m ati o n 
a b o ut y o ur st u d y p arti ci p ati o n i n y o ur m e di c al r e c or d.  W 
e will n ot s h ar e y o ur st u d y r e c or d s or 
i d e ntif y y o u ex c e pt a s d e s cri b e d i n t hi s i nf or m e d c o n s e nt d o c u m e nt. T h er e ar e ti m e s w h e n w e 
mi g ht h a v e t o s h o w y o ur r e c or d s t o ot h er p e o pl e.  F or ex a m pl e, s o m e o n e fr o m t h e O ffi c e of 
H u m a n R e s e ar c h Pr ot e cti o n s, t h e G o v er n m e nt A c c o u nt a bilit y O ffi c e, t h e O ffi c e of t h e I n s p e ct or 
G e n er al, t h e V A O ffi c e of R e s e ar c h O v er si g ht, t h e V A C e ntr al IR B , o ur l o c al R e s e ar c h a n d 
D e v el o p m e nt C o m mitt e e, a n d ot h er st u d y m o nit or s m a y l o o k at or c o p y p orti o n s of r e c or d s t h at 
i d e ntif y y o u. 
 
W 
e h a v e o bt ai n e d a C ertifi c at e of C o nfi d e nti alit y fr o m t h e F e d er al G o v er n m e nt.  T hi s h el p s 
pr ot e ct y o ur pri v a c y b y all o wi n g u s t o r ef u s e t o r el e a s e y o ur n a m e or ot h er i nf or m ati o n o ut si d e 
of t h e r e s e ar c h st u d y, e v e n b y a c o urt or d er.  T h e C ertifi c at e of C o nfi d e nti alit y will n ot b e u s e d 
t o pr e v e nt di s cl o s ur e s t o l o c al a ut h oriti e s of c hil d or el d er a b u s e a n d n e gl e ct, h ar m t o s elf or 
ot h er s, or if w e b e c o m e a w ar e t h at y o u h a v e a n i nf e cti o u s di s e a s e t h at St at e or F e d er al L a w 
r eq uir e s u s t o r e p ort.  If w e l e ar n of s u c h a sit u ati o n, w e ar e m a n d at e d t o a ct a p pr o pri at el y, 
w hi c h m a y i n cl u d e r e v e ali n g y o ur i d e ntit y a s a r e s e ar c h p arti ci p a nt t o a ut h oriti e s.   T h e 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 4  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
C ertifi c at e d o e s n ot pr e v e nt y o u or a m e m b er of y o ur f a mil y fr o m r el e a si n g d at a a b o ut y o ur s elf 
or y o ur i n v ol v e m e nt i n t hi s st u d y. 
 
D uri n g t hi s r e s e ar c h st u d y w e will u s e p er s o n al a n d h e alt h i nf or m ati o n f or t h e s ci e ntifi c g o al s 
of t h e st u d y.  T h e i nf or m ati o n c oll e ct e d f or t hi s st u d y will b e k e pt c o nfi d e nti al ex c e pt w h er e 
di s cl o s ur e i s r eq uir e d b y l a w.  F or ex a m pl e, if y o u a p p e ar t o w a nt t o d o h ar m t o y o ur s elf 
( s ui ci d e)  or t o ot h er s, w e will r e p ort t hi s i nf or m ati o n t o t h e a p pr o pri at e a ut h oriti e s a n d a s si st 
y o u i n o bt ai ni n g c ar e.  W 
e m a y al s o c o nt a ct y o ur pri m ar y m e nt al h e alt h pr o vi d er r e g ar di n g 
cli ni c all y si g nifi c a nt st at u s c h a n g e s. All l o c al, st at e a n d f e d er al r e g ul ati o n s will b e f oll o w e d 
w h e n r el e a si n g st u d y d at a.  A n y r e p ort s or p u bli c ati o n s r e s ulti n g fr o m t hi s st u d y will n ot 
i n cl u d e a n y i nf or m ati o n t h at c o ul d i d e ntif y y o u.  
 
W 
e will u s e y o ur S SN  t o a c c e s s V A d at a b a s e s t o ex tr a ct i nf or m ati o n a b o ut y o ur u s e of V A 
h e alt h c ar e s er vi c e s o ut si d e of t h e tri al, i n cl u di n g t h o s e pr o vi d e d b y n o n- V A pr o vi d er s t h at t h e 
V A p a y s f or, a n d t h e c o st s of t h e s e s er vi c e s.  T hi s i n cl u d e s r e c or d s o n all of t h e m e di ci n e s t h at 
y o u r e c ei v e fr o m t h e V A.   Y o ur S SN  will b e m at c h e d t o t h e s cr a m bl e d S SN  t h at t h e V A u s e s a s 
a p ati e nt i d e ntifi er i n t h e s e d at a s et s.  Y o ur a ct u al S SN  will o nl y b e u s e d t o o bt ai n t h e s cr a m bl e d 
S SN ;  t h e r e al a n d s cr a m bl e d S SN s will n e v er b e i n t h e s a m e d at a fil e a n d t h e r e al S SN  will b e 
i n a n e n cr y pt e d fil e ex c e pt f or w h e n w e u s e it t o li n k t o t h e s cr a m bl e d S SN . 
 
Y o ur s o ci al s e c urit y n u m b er a n d n a m e will b e k e pt s e p ar at e fr o m all of y o ur st u d y d at a.  I n 
si g ni n g t hi s i nf or m e d c o n s e nt y o u a ut h oriz e t h e u s e of y o ur s o ci al s e c urit y n u m b er a n d l a s t 
n a m e f or a d mi ni str ati v e a c c e s s t o t h e d at a b a s e s d e s cri b e d a b o v e.  Y o u m a y n ot p arti ci p at e i n 
t hi s st u d y if y o u ar e n ot willi n g t o gi v e u s y o ur s o ci al s e c urit y n u m b er. 
 
D at a c oll e ct e d d uri n g t h e st u d y will b e st or e d i n a w a y t h at d o e s n ot i d e ntif y y o u b y n a m e.  
All d at a f or m s a n d r e p ort s will b e c o d e d.  R e s e ar c h a n d cli ni c al r e c or d s will b e st or e d i n a 
l o c k e d c a bi n et.  O nl y s el e ct e d st u d y r e s e ar c h er s will h a v e a c c e s s t o t hi s i nf or m ati o n.  T h e y 
ar e b o u n d b y r ul e s of c o nfi d e nti alit y n ot t o r e v e al i d e ntif yi n g i nf or m ati o n t o ot h er s.  All d at a 
c oll e ct e d f or t hi s st u d y will b e s e nt el e ctr o ni c all y vi a a s e c ur e f ax  a n d/ or o nli n e s er v er t o t h e 
V A C o o p er ati v e St u di e s Pr o gr a m C o or di n ati n g C e nt er (  C S P C C) , P err y P oi nt, M ar yl a n d a n d 
will b e k e pt i n a s e c ur e d at a b a s e.  T h e C S P C C will b e r e s p o n si bl e f or t h e pr o c e s si n g a n d 
a n al y s e s of all r e s e ar c h d at a.  T h e C h air m a n’ s Offi c e (l o c at e d at V A M C P al o Alt o, C A), t h e 
C o o p er ati v e St u di e s Pr o gr a m Cli ni c al R e s e ar c h P h ar m a c y C o or di n ati n g C e nt er i n 
Al b uq u erq u e, N  M a n d m e m b er s of t h e E x e c uti v e C o m mitt e e a n d t h e D at a M o nit ori n g 
C o m mitt e e, a s w ell a s m o nit ori n g b o di e s a s s o ci at e d wit h t h e st u d y will r e vi e w r e s e ar c h d at a.  
St u d y r e c or d s will b e k e pt f or t h e l e n gt h of ti m e r eq uir e d b y l a w aft er t h e st u d y i s c o m pl et e d. 
  

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 5  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
A ut h oriz e d p er s o n n el fr o m t h e V A will s e e y o ur m e di c al r e c or d s a n d t h e c o n s e nt f or m t h at 
y o u si g n e d.  O t h er f e d er al a g e n ci e s s u c h a s t h e F o o d a n d Dr u g A d mi ni str ati o n ( F D A)  a n d 
ot h er F e d er al a g e n ci e s;  e. g., t h e O ffi c e f or H u m a n R e s e ar c h Pr ot e cti o n ( O H R P)  a n d t h e 
G o v er n m e nt A c c o u nt a bilit y O ffi c e ( G AO ) , t h e O ffi c e of t h e I n s p e ct or G e n er al, t h e V A O ffi c e 
of R e s e ar c h O v er si g ht, t h e V A C e ntr al IR B , o ur l o c al R e s e ar c h a n d D e v el o p m e nt 
C o m mitt e e, a n d ot h er st u d y m o nit or s m a y r e vi e w y o ur r e c or d s t o m a k e s ur e t h at t h e y m e et 
f e d er al, st at e or l o c al r e g ul ati o n s.  B e c a u s e of t h e n e e d t o all o w a c c e s s t o y o ur m e di c al 
r e c or d s b y t h e s e a g e n ci e s, a b s ol ut e c o nfi d e nti alit y c a n n ot b e g u ar a nt e e d b ut e v er y eff ort will 
b e m a d e t o k e e p i nf or m ati o n a b o ut y o u b ot h pri v at e a n d c o nfi d e nti al.  
 
Y o u will n ot b e a bl e t o h a v e a c c e s s t o t h e r e s e ar c h d at a t h at h a s b e e n c oll e ct e d a b o ut y o u 
d uri n g t h e st u d y.  H o w e v er, aft er t h e st u d y i s c o m pl et e d, w hi c h i s aft er l a st p arti ci p a nt h a s 
c o m pl et e d t h eir f oll o w- u p, y o u will b e n otifi e d w hi c h tr e at m e nt y o u r e c ei v e d d uri n g t h e st u d y. 
 
B y si g ni n g t hi s i nf or m e d c o n s e nt f or m, y o u ar e gi vi n g u s p er mi s si o n t o u s e t h e i nf or m ati o n 
c oll e ct e d a b o ut y o ur h e alt h o nl y u ntil t h e e n d of t h e st u d y.  Y o u h a v e t h e ri g ht, at a n y ti m e, 
t o t a k e b a c k y o ur p er mi s si o n t o u s e y o ur p er s o n al h e alt h i nf or m ati o n f or r e s e ar c h p ur p o s e s.  
H o w e v er, if y o ur i nf or m ati o n h a s alr e a d y b e e n s e nt t o t h e P err y P oi nt C o o p er ati v e St u di e s 
Pr o gr a m C o or di n ati n g C e nt er or h a s b e e n c o m bi n e d wit h ot h er p arti ci p a nt s’ i nf or m ati o n 
( s u c h a s w h e n n u m b er s ar e a v er a g e d)  it will c o nti n u e t o b e u s e d.  N o f urt h er i nf or m ati o n 
a b o ut y o u will b e c oll e ct e d.  W h e n y o ur i nf or m ati o n i s c o m bi n e d wit h ot h er p arti ci p a nt s’ 
i nf or m ati o n i n t h e st u d y, y o ur p er s o n al i nf or m ati o n c a n n ot b e i d e ntifi e d. 
 
If y o u h a v e a n y q u e sti o n s a b o ut wit h dr a wi n g y o ur p er mi s si o n, y o u m a y c o nt a ct [ i n s ert n a m e]  
at [ i n s ert p h o n e n u m b er] .  T o wit h dr a w y o ur p er mi s si o n f or t h e u s e of y o ur p er s o n al h e alt h 
i nf or m ati o n, y o u m u st c o nt a ct Dr. [ i n s ert n a m e of PI]  i n writi n g at [i n s ert a d dr e s s] .  If y o u 
wit h dr a w p er mi s si o n or d o n ot gi v e y o ur p er mi s si o n, y o u will still r e c ei v e all t h e m e di c al c ar e 
a n d b e n efit s f or w hi c h y o u ar e ot h er wi s e eli gi bl e b ut y o u will b e u n a bl e t o c o nti n u e i n t hi s 
r e s e ar c h st u d y. 
 
C O S T S T O P A R TI CI P A N T S A N D P A Y M E N T 
 
C o st s t o P arti ci p a nt s    
 
Y o u , y o ur i n s ur a n c e c o m p a n y or a n y ot h er t hir d p art y p a y er will n ot b e bill e d f or a n y st u d y-
r el at e d tr e at m e nt s, bl o o d or uri n e t e st s or ot h er pr o c e d ur e s t h at ar e p art of t hi s st u d y a n d n ot 
p art of y o ur r o uti n e tr e at m e nt.  If y o u r e c ei v e tr e at m e nt t h at i s p art of y o ur u s u al c ar e, y o u m a y 
b e bill e d a s y o u u s u all y ar e. 
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 6  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
F or v et er a n s w h o ar e r eq uir e d t o p a y c o- p a y m e nt s f or m e di c al c ar e a n d s er vi c e s pr o vi d e d b y 
V A, t h e s e c o- p a y m e nt r eq uir e m e nt s will c o nti n u e t o a p pl y f or m e di c al c ar e a n d s er vi c e s 
pr o vi d e d b y V A t h at ar e n ot p art of t hi s st u d y. 
 
P a y m e nt Off er e d f or P arti ci p ati o n    
 
Y o u will b e c o m p e n s at e d f or y o ur ti m e a n d i n c o n v e ni e n c e.  Y o u will b e r e s p o n si bl e f or 
tr a n s p ort ati o n t o a n d fr o m all tr e at m e nt a n d f oll o w- u p s e s si o n s.  
 
Y o u will b e p ai d f or y o ur ti m e a n d i n c o n v e ni e n c e i n e a c h of t h e t hr e e st u d y p h a s e s a s 
f oll o w s: 
  
S cr e e ni n g P h a s e:     $ 4 0 
  I nt er v e nti o n P h a s e:  $ 3 0 0 
  
F oll o w- u p P h a s e:     $ 6 0  
 
If y o u wit h dr a w or st o p e arl y i n a n y of t h e t hr e e p h a s e s, y o u will b e p ai d a c c or di n g t o 
w h at p h a s e y o u ar e i n.  F or ex a m pl e, if y o u wit h dr a w at a n y ti m e d uri n g t h e I nt er v e nti o n 
P h a s e y o u w o ul d r e c ei v e p a y m e nt of $
4 0 f or t h e s cr e e ni n g p h a s e a n d $ 3 0 0 f or t h e 
I nt er v e nti o n P h a s e, b ut n ot $ 6 0  f or t h e f oll o w- u p p h a s e.  If y o u c o m pl et e all t hr e e p h a s e s 
y o u w o ul d r e c ei v e a t ot al o f $ 4 0 0. 
 
M E DI C A L T R E A T M E N T A N D C O M P E N S A TI O N F O R I N J U R Y    
 
E v er y r e a s o n a bl e s af et y m e a s ur e will b e u s e d t o pr ot e ct y o ur w ell- b ei n g.  If y o u ar e i nj ur e d a s a 
r e s ult of t a ki n g p art i n t hi s st u d y, t h e V A will pr o vi d e n e c e s s ar y m e di c al tr e at m e nt at n o c o st t o 
y o u.  Fi n a n ci al c o m p e n s ati o n i s n ot a v ail a bl e f or s u c h t hi n g s a s l o st w a g e s, di s a bilit y or 
di s c o mf ort d u e t o a n i nj ur y. 
 
If y o u s h o ul d h a v e a m e di c al c o n c er n or g et h urt or si c k a s a r e s ult of t a ki n g p art i n t hi s st u d y, 
c all:   
DU R IN G  TH E  D A Y: 
 
Dr./  Mr./  M s.                                                       at                                                 a n d  
 
A F TE R  H O U
R S: 
 
Dr. /  Mr. /  M s. _
_ _ _ _                                            at _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .                                   
 
E  m er g e n c y a n d o n g oi n g m e di c al tr e at m e nt will b e pr o vi d e d a s n e e d e d.   

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 7  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
 
Y o u d o n ot gi v e u p a n y of y o ur l e g al ri g ht s a n d y o u d o n ot r el e a s e t h e V A fr o m a n y li a bilit y b y 
si g ni n g t hi s f or m.    
 
I n c a s e of a n e m er g e n c y i n w hi c h y o u ar e u n a bl e t o r e a c h [ i n s ert n a m e of PI at ( a d d c o nt a ct 
i nf or m ati o n) ] , pl e a s e c all 9 1 1 or g o t o t h e n e ar e st e m er g e n c y r o o m.   
  
N o pr o mi s e s h a v e b e e n gi v e n t o y o u si n c e t h e r e s ult s a n d t h e ri s k s of a r e s e ar c h st u d y ar e n ot 
al w a y s k n o w n i n a d v a n c e.  H o w e v er, e v er y r e a s o n a bl e s af et y m e a s ur e will b e t a k e n t o pr ot e ct 
y o ur w ell- b ei n g.  Y o u h a v e n ot r el e a s e d t hi s i n stit uti o n fr o m li a bilit y f or n e gli g e n c e.  
 
V O L U N T A R Y P A R TI CI P A TI O N 
 
Y o ur p arti ci p ati o n i s v ol u nt ar y. It i s u p t o y o u t o d e ci d e w h et h er or n ot t o t a k e p art i n t hi s st u d y. 
If y o u d o n ot wi s h t o b e i n t hi s st u d y or l e a v e t h e st u d y e arl y, y o u will n ot l o s e a n y b e n efit s t o 
w hi c h y o u ar e ot h er wi s e e ntitl e d a n d still r e c ei v e all u s u al c ar e t h at i s a v ail a bl e t o y o u.  Y o ur 
d e ci si o n n ot t o t a k e p art will n ot aff e ct t h e r el ati o n s hi p y o u h a v e wit h y o ur d o ct or or ot h er st aff 
a n d it will n ot aff e ct t h e u s u al c ar e t h at y o u r e c ei v e a s a p ati e nt.   
 
If y o u d e ci d e t o t a k e p art y o u m a y still wit h dr a w y o ur c o n s e nt at a n y ti m e a n d st o p 
p arti ci p ati o n wit h o ut p e n alt y or l o s s of b e n efit s .  Y o u ar e n ot w ai vi n g a n y l e g al cl ai m s, ri g ht s 
or r e m e di e s b e c a u s e of y o ur p arti ci p ati o n i n t hi s r e s e ar c h st u d y.  If y o u l e a v e t h e st u d y e arl y 
f or a n y r e a s o n, it i s i m p ort a nt t o c o m e i n f or a fi n al st u d y vi sit t o e n s ur e a p pr o pri at e f oll o w-u p 
c ar e o ut si d e of t hi s r e s e ar c h st u d y. 
 
F or d at a alr e a d y c oll e ct e d pri or t o y o ur wit h dr a w al, t h e i n v e sti g at or m a y c o nti n u e t o r e vi e w t h e 
d at a alr e a d y c oll e ct e d f or t h e st u d y b ut c a n n ot c oll e ct f urt h er i nf or m ati o n, ex c e pt fr o m p u bli c 
r e c or d s, s u c h a s s ur vi v al d at a.  S p e ci m e n s alr e a d y u s e d c a n n ot b e wit h dr a w n. 
 
RI G H T O F I N V E S TI G A T O R T O T E R MI N A T E P A R TI CI P A TI O N 
 
At t h e di s cr eti o n of t h e st u d y t e a m y o u m a y b e wit h dr a w n fr o m t hi s st u d y.  
 
P o s si bl e r e a s o n s f or wit h dr a wi n g y o u fr o m t h e st u d y i n cl u d e: 
 
  
Y o u f ail t o f oll o w i n str u cti o n s. 
  
Y o u dri n k m or e t h a n o n e gl a s s of al c o h ol a d a y, d efi n e d a s 1 2 oz . b e er, 5 oz . wi n e, or 1. 5 
oz . h ar d liq u or 
  
Y o u a b u s e ill e g al dr u g s. 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 8  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _                       
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _                  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _        
 
 
 
 
                                                                        
 
 
 
 
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y                                                                           
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
 
F O R V A C E N T R A L I R B U S E O N L Y  
 
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
 
L SI A p pr o v al D at e:    n/ a 
 
L SI V erifi c ati o n D at e:     n/ a  
 
  
Y o u a b u s e or mi s u s e pr e s cri pti o n dr u g s. 
  
Y o u b e c o m e pr e g n a nt. 
  T h e i n v e sti g at or d e ci d e s t h at c o nti n u ati o n c o ul d b e h ar mf ul t o y o u. 
  
Y o u n e e d tr e at m e nt n ot p er mitt e d f or p arti ci p ati o n i n t h e st u d y. 
  T h e st u d y i s c a n c elle d.  
 O t h er a d mi ni str ati v e r e a s o n s. 
 U n a nti ci p at e d cir c u m st a n c e s. 
 
If y o u l e a v e t h e st u d y e arl y f or a n y r e a s o n, it i s i m p ort a nt t o c o m e i n f or a fi n al st u d y vi sit t o 
e n s ur e a p pr o pri at e f oll o w- u p c ar e o ut si d e of t hi s r e s e ar c h st u d y. 
 
P E R S O N S T O C O N T A C T 
 
If y o u h a v e a n y q u e sti o n s, c o m pl ai nt s, a n d c o n c er n s a b o ut t h e r e s e ar c h or r el at e d m att er s, y o u 
m a y c o nt a ct     
  
, t h e p arti ci p ati n g i n v e sti g at or at   
  
  
 
,  
  
  
  
, t h e st u d y c o or di n at or at   
  
  
  
, or t h e P ati e nt 
A d v o c at e of t h e [ i n s ert M e di c al C e nt er n a m e h er e] at  
 
 
 
 
. 
 
If y o u h a v e q u e sti o n s a b o ut y o ur ri g ht s a s a st u d y p arti ci p a nt, or y o u w a nt t o m a k e s ur e t hi s i s a 
v ali d V A st u d y, y o u m a y c o nt a ct t h e V A C e ntr al I n stit uti o n al R e vi e w B o ar d ( IR B ) .  T hi s i s t h e 
B o ar d t h at i s r e s p o n si bl e f or o v er s e ei n g t h e s af et y of h u m a n p arti ci p a nt s i n t hi s st u d y.  Y o u m a y 
c all t h e V A C e ntr al IR B  t oll fr e e at 1- 8 7 7 - 2 54 -3 13 0 if y o u h a v e q u e sti o n s, c o m pl ai nt s or 
c o n c er n s a b o ut t h e st u d y.   
 
SI G NI FI C A N T N E W FI N DI N G S  
 
S o m eti m e s d uri n g t h e c o ur s e of a r e s e ar c h st u d y, n e w i nf or m ati o n b e c o m e s a v ail a bl e a b o ut t h e 
tr e at m e nt t h at i s b ei n g st u di e d t h at c o ul d c h a n g e y o ur willi n g n e s s t o c o nti n u e i n t h e st u d y.  If 
t hi s h a p p e n s, y o ur r e s e ar c h d o ct or will t ell y o u a b o ut it a n d di s c u s s wit h y o u w h et h er y o u w a nt 
t o c o nti n u e i n t h e st u d y.  If y o u d e ci d e t o wit h dr a w at t h at ti m e, y o ur r e s e ar c h d o ct or will m a k e 
arr a n g e m e nt s f or y o ur m e di c al c ar e t o c o nti n u e.  If y o u d e ci d e t o c o nti n u e i n t h e st u d y, y o u m a y 
b e a s k e d t o si g n a n u p d at e d c o n s e nt f or m.  Y o ur r e s e ar c h d o ct or c o ul d al s o d e ci d e t h at it m a y 
b e  i n y o ur b e st i nt er e st s t o wit h dr a w y o u fr o m t h e st u d y.  H e/ s h e will ex pl ai n t h e r e a s o n s a n d 
arr a n g e f or y o ur m e di c al c ar e t o c o nti n u e.  
 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 1 9  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _  
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _  
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y     
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
F O R V A C E N T R A L I R B U S E O N L Y  
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
L SI A p pr o v al D at e:    n/ a 
L SI V erifi c ati o n D at e:     n/ a  
A G R E E M E N T T O P A R TI CI P A T E I N T H E R E S E A R C H S T U D Y 
Dr./  Mr./  M s. 
 h a s ex pl ai n e d t h e r e s e ar c h st u d y t o y o u. Y o u h a v e 
b e e n  t ol d of t h e ri s k s or di s c o mf ort s a n d p o s si bl e b e n efit s of t h e st u d y. Y o u h a v e b e e n t ol d of 
ot h er c h oi c e s of tr e at m e nt a v ail a bl e t o y o u.  Y o u h a v e b e e n gi v e n t h e c h a n c e t o a s k q u e sti o n s 
a n d o bt ai n a n s w er s.   
Y o u v ol u nt aril y c o n s e nt t o p arti ci p at e i n t hi s st u d y.  Y o u al s o c o nfir m t h at y o u h a v e r e a d t hi s 
c o n s e nt, or it h a s b e e n r e a d t o y o u.  Y o u will r e c ei v e a c o p y of t hi s c o n s e nt aft er y o u si g n it.  A 
c o p y of t hi s si g n e d c o n s e nt will al s o b e p ut i n y o ur m e di c al r e c or d if a p pli c a bl e.  
I a gr e e t o p arti ci p at e i n t hi s r e s e ar c h st u d y a s y o u h a v e e x pl ai n e d i n t hi s d o c u m e nt. 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
P arti ci p a nt’ s N a m e  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
P arti ci p a nt’ s Si g n at ur e  
_ _ _ _ _ _ _ _ _ _ _  
D at e  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
N a m e of p er s o n o bt ai ni n g 
a ut h oriz ati o n a n d c o n s e nt  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Si g n at ur e of p er s o n o bt ai ni n g 
a ut h oriz ati o n a n d c o n s e nt  
_ _ _ _ _ _ _ _ _ _ _ _ _  
D at e 

V A  D e p art m e nt of V et er a n s Aff air s  
V A  R E S E A R C H  C O N S E N T  F O R M 
V er si o n D at e: F e br u ar y 2 0 1 6  
P a g e 2 0  of 2 0  
P arti ci p a nt N a m e:                                                                                            D at e:   _ _ _ _ _ _ _ _ _  
Titl e of St u d y: _
C S P # 5 5 6, “ T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s” _ _ _ _ _ _ _ _ _  
Pri n ci p al I n v e sti g at or:  J er o m e Y e s a v a g e, M. D.                     F a cilit y: _
P al o Alt o V A M C _ _ _ _ _ _  
V A F O R M 1 0- 1 0 8 6 a s m o difi e d b y     
t h e V A C e ntr al I R B o n M ar c h 1 0, 2 0 1 0 
F O R V A C E N T R A L I R B U S E O N L Y  
P I/S C A p pr o v al D at e: 0 2/ 0 8/ 2 0 1 6 
L SI A p pr o v al D at e:    n/ a 
L SI V erifi c ati o n D at e:     n/ a  
A T T A C H M E N T 1 - C O N S E N T F O R M Q U E S TI O N S 
T h e Eff e cti v e n e s s of r T M S i n D e pr e s s e d V A P ati e nt s  
  TR U E   
 F AL SE  
1)
Y o ur p arti ci p ati o n i n t hi s r e s e ar c h st u d y i s v ol u nt ar y.
2)
T h er e ar e n o p ot e nti al ri s k s or si d e eff e ct s a s s o ci at e d
wit h t h e u s e of t hi s ex p eri m e nt al d e vi c e i n t hi s r e s e ar c h st u d y.
3 )
Y o ur p arti ci p ati o n i n t h e st u d y m a y l a st u p t o 2 1 w e e k s.
4 )
Y o u will n ot h a v e t o gi v e a n y bl o o d or uri n e s a m pl e s
at a n y ti m e d uri n g t h e c o ur s e of t h e st u d y.
5)
Y o ur p arti ci p ati o n i n t h e st u d y will b e k e pt c o nfi d e nti al
ex c e pt a s r eq uir e d b y l a w.
6)
T h e st u d y st aff m a y e n d y o ur p arti ci p ati o n i n t hi s st u d y if
t h e y f e el t h at t o d o s o w o ul d b e i n y o ur b e st i nt er e st.
7 )
Y o u will b e c o m p e n s at e d d uri n g t hi s tri al f or c o m pl eti n g all
r eq uir e d t e st s a n d st u d y a s s e s s m e nt s.
8 ) 
A w o m a n w h o b e c o m e s pr e g n a nt d uri n g t h e i nt er v e nti o n
p h a s e of t h e st u d y m a y c o nti n u e t o r e c ei v e r T M S tr e at m e nt s
a n d will n ot b e t er mi n at e d fr o m t h e st u d y.
9 ) 
Y o u d o n ot h a v e t o i nf or m t h e st u d y st aff of a n y n e w m e di ci n e s
t h at y o u t a k e d uri n g t h e st u d y.
1 0) 
Y o u will r e c ei v e a cti v e “r e al r T M S” tr e at m e nt.
1 1) 
Aft er y o ur fi n al f oll o w- u p vi sit, y o u will n ot r e c ei v e f urt h er
r T M S tr e at m e nt a s a p art of t h e st u d y.
 T h e c orr e ct a n s w er s t o t h e q u e sti o n s a b o v e h a v e b e e n di s c u s s e d wit h m e. 
P arti ci p a nt’ s Si g n at ur e  
 D at e 

Subjects Name: _________________, ______________ 
     Last 
         First 
Version October 2012 
HIPAA Authorization      
Palo Alto VA Medical Center  
Research and Development Service 
Written Permission for Release of Protected Health Information for 
Research Purposes 
Title of Study: The Effectiveness of Repetitive Transcranial Magnetic Stimulation 
(rTMS) in Depressed VA Patients
You have been asked to be part of a research study called The Effectiveness of 
Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed VA Patients. 
Dr. Jerome Yesavage  and members of  his research team are in charge of this 
study at this VA.  We hope to learn whether rTMS is effective for treatment-
resistant major depression. As part of this study, we will be collecting and sharing 
information about you with others.   
We understand that information about you obtained in connection with your health 
care is private.  The Palo Alto VA Medical Center has rules to protect 
information about you.  In our research, we use and share information about people 
and their health.  The law lets us use and share health information for research if 
you agree to let us do this.  Federal and state laws protect health information.  If 
you let us use and share information about you, we will protect it as required by 
law.  This form explains how we will use and share your health information.  It 
lists who can see and use your information.  It explains what we will do to keep 
your information private. 
If you sign this form, it means you are letting us use and share this information for 
research. 
Who will share, receive, and/or use the information? 
In addition to Dr. Jerome Yesavage and his research staff, the following 
individuals will or may have access to your identifiable medical record information 
related to your participation in this research study:  
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Appendix A – Human Rights Issues and IFC
Version 4.0, September 2013
49

Subjects Name: _________________, ______________ 
     Last 
         First 
Version October 2012 
Authorized representatives of the Veterans Affairs Central Institutional 
Review Board (IRB) and the local IRB and Research and Development 
Committee where you receive VA care may review your identifiable 
medical record information for the purpose of monitoring the appropriate 
conduct of this research study.  
Authorized representatives of the Veterans Affairs Cooperative Studies 
Program and their Coordinating Center at Perry Point, MD will review 
and/or obtain your identifiable medical record information for the purpose of 
monitoring the accuracy and completeness of the research data and for 
performing required scientific analyses of the research data. 
Authorized representatives of the Veterans hospital or other affiliated health 
care providers you are receiving care from may have access to your 
identifiable medical record information.   
The following individuals, for purposes of monitoring and oversight of this 
research activity may include: 
Any agency of the federal, state, or local government that regulates 
this research.  This includes the Food and Drug Administration (FDA) 
and the Department of Health and Human Services (DHHS). 
Office for Human Research Protection (OHRP) 
Government Accountability Office 
The Office of the Inspector General 
In unusual cases, the investigators may be required to release your 
identifiable research information (which may include your identifiable 
medical record information) in response to an order from a court of law.  If 
the investigators learn that you or someone with whom you are involved is 
in serious danger or potential harm, they will need to inform, as required by 
state law, the appropriate agencies.   
Who else can use and share this information? 
Anyone listed above may use consultants or other associates with whom they have 
a formal business relationship, such as through a contract, to help them understand, 
analyze, and conduct this study.  They may use and share information about you to 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Appendix A – Human Rights Issues and IFC
Version 4.0, September 2013
50

Subjects Name: _________________, ______________ 
     Last 
         First 
Version October 2012 
do this research with these consultants or other associates.  If you have questions 
about who they are, you can ask us. 
What personal health information will be shared and used? 
Medical information, reports and questionnaire data from study-related visits 
such as neuropsychological and  PTSD data, and substance abuse disclosure. 
Medical information, including demographics, from VA data systems. 
Information about use and cost of all VA-provided health care (obtained 
from centralized VA data systems called electronic abstracts utilizing SSN). 
Information about use and costs of all non-VA healthcare covered by 
Medicare (obtained from centralized Medicare databases). 
We will use and share your information only as described in this form.  People 
outside the Palo Alto VA Medical Center and the Perry Point VA Cooperative 
Studies Program Coordinating Center who receive your information may not be 
covered by this promise.  Once information is shared outside the VA, it may not be 
protected in the same manner and may be subject to re-disclosure by the recipient. 
We try to make sure that everyone who needs to see your information keeps it 
confidential – but we cannot guarantee this. 
By signing this document, you will authorize the Veterans Health Administration 
(VHA) to permit Dr. Jerome Yesavage and members of his/her research team to 
use and share the protected health information (PHI) described above. 
Your Rights 
You can refuse to sign this form. 
If you do not sign this form: 
You will not be able to take part in this research. 
 This will not change or affect your health care outside of this study. 
This will not change or affect your VA benefits or health care benefits. 
How Long Will My Permission Last? 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Appendix A – Human Rights Issues and IFC
Version 4.0, September 2013
51

Subjects Name: _________________, ______________ 
     Last 
         First 
Version October 2012 
This permission will expire when this research study is completed, unless you 
revoke it in writing first. 
Can I Withdraw My Permission? 
You can revoke or cancel your permission at any time.  To do so, you must 
write a letter to Dr. Jerome Yesavage and address to:  Department of 
Veterans Affairs, 3801 Miranda Avenue, Palo Alto, CA  94304.  You can 
ask a member of the research team to give you a form to cancel your 
permission.   
Your request will be valid when Dr Yesavagereceives your request.   
We will stop collecting information about you.  
You cannot withdraw information that we had before you told us to stop.  
We may already have used or shared it.  Or we may need it to complete the 
research. 
Staff may follow-up with you if there is a medical reason to do so. 
Participant Authorization: 
I have read this form.     
I have been given the chance to ask questions. 
My questions have been answered.  
If I have more questions, I am to call <insert name and contact 
information> 
I agree to the release of my protected health information as described in 
this form. 
I will receive a copy of this authorization form after I sign it. 
_______________________________________________________ 
Participant’s Signature 
 
Date 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Appendix A – Human Rights Issues and IFC
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52

Subjects Name: _________________, ______________ 
     Last 
         First 
Version October 2012 
Revocation of Authorization for Release of Protected Health Information 
For Research Purposes 
Title of Study: The Effectiveness of Repetitive Transcranial Magnetic Stimulation 
(rTMS) in Depressed VA Patients      
TO:   Dr. Jerome Yesavage 
I revoke my previous authorization for you to use or disclose my protected health 
information (PHI) as part of your study. 
I understand that the research team may continue to use and disclose PHI about me 
that has already been collected if such continued use is necessary to protect the 
integrity of this research study.  However, they will use and disclose PHI only for 
the reasons discussed in the  Informed Consent Form (ICF) I signed when I joined 
the study. 
I understand the revoking this authorization may mean that my participation in the 
study will also end.  It will not affect my rights as a VHA patient, including health 
care I may need when I am no longer in the study. 
Signed: 
________________________________________________ 
Participant Signature 
Date 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Appendix A – Human Rights Issues and IFC
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53

APPENDIX B 
Study Budget 

 
 
 

 
 
 
 
APPENDIX C 
 
CURRICULA VITAE   
 
 
Jerome A. Yesavage, M.D. 
Principal Proponent 
 
Kousick Biswas, PhD 
Study Biostatistician 
 
 

 
 
 
 
 

 
_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix C – Curricula Vitae 
 
C-1 
Department of Veterans Affairs 
RESEARCH AND 
DEVELOPMENT PROGRAM
INVESTIGATOR’S BIOGRAPHICAL 
SKETCH 
NAME 
Yesavage, Jerome A.  
POSITION TITLE 
ACOS, Mental Health 
EDUCATION / TRAINING 
(Begin with Baccalaureate or other initial professional education, such as nursing, and include post-doctoral 
training. Do not include Honorary Degree.) 
NAME, LOCATION OF INSTITUTION 
Yale University, New Haven, Connecticut 
Stanford University, Stanford, California 
DEGREE (if 
applicable) 
BA 
MD 
YEAR 
AWARDED 
1971 
1974 
FIELD OF STUDY 
Philosophy 
Medicine 
NOTE: The Biographical Sketch may not exceed four pages. Items A and B (together) may not exceed two of the four-pages.  
A. Positions and Honors  
(List in chronological order previous positions, concluding with your present position. List any honors, professional memberships or present 
membership on any Federal Government public advisory committee.) 
Positions and Employment: 
1978-1996 
Director, Psychiatric Intensive Care Unit, VA Medical Center, Palo Alto, California 
1979-1985 
Assistant Professor of Psychiatry, Stanford University, Stanford, California 
1980-present 
Associate Director, Gero-Psychiatric Rehabilitation Unit, VA Medical Center, Palo Alto, CA 
1985-1990 
Member, Life Course (Aging) Review Board, NIMH 
1985-1991 
Associate Professor of Psychiatry, Stanford University, Stanford, California 
1991-present 
Professor of Psychiatry, Stanford University, Stanford, California 
1996-2001 
Director, Psychiatric Inpatient Units, VA Palo Alto Health Care System, Palo Alto, California 
1998-present 
Director, Department of Veterans Affairs Sierra-Pacific Mental Illness, Research, Education, and Clinical   
 
Center (MIRECC) 
2001-2002 
Acting Associate Chief of Staff for Mental Health, VA Palo Alto Health Care System, Palo Alto, CA 
2002-present 
Associate Chief of Staff for Mental Health, VA Palo Alto Health Care System, Palo Alto, CA 
Other Experience and Professional Memberships: 

 
_____________________________________________________ 
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Appendix C – Curricula Vitae 
 
C-2 
1985-1989 
Member, Life Course (Aging) peer review section for NIMH Aging proposals 
1998-present 
Stanford University School of Medicine, Department of Psychiatry, Executive Committee 
1979-present 
Gerontological Society of America 
1982-present 
International Psychogeriatric Association 
1982-present 
Family Survival Project, Scientific Advisory Council 
2000-present  EthicAd.org National Advisory Board 
Honors: 
1971 
 
Graduated magna cum laude with Class Prize in Philosophy, Yale University 
1974 
 
Class Prize in Psychiatry, Stanford University, Stanford, California  
1976 
 
Falk Fellow, American Psychiatric Association 
1978 
 
American Gerontology Traveling Fellowship 
1989-1992 
Chair, Council on Aging, American Psychiatric Association 
1993 
 
Weinberg Award for Excellence in Geriatric Psychiatry, American Psychiatric Association 
1993 
 
Advisory Panel on Alzheimer's Disease, United States Congress 
B. Selected peer-reviewed publications (in chronological order) 
(Do not include publications submitted or in preparation) 
Brooks JO, Hoblyn JC, Kraemer HC, Yesavage JA: Factors associated with psychiatric hospitalization of dementia patients 
with comorbid bipolar disorder. Journal of Geriatric Psychiatry and Neurology 19: 72-77, 2006.  
Chuu JY, Taylor JL, Tinklenberg J, Noda A, Yesavage JA, Murphy GM: The brain-derived neurotropic factor Val66Met 
polymorphism and rate of decline in Alzheimer's disease. Journal of Alzheimer's Disease 9: 43-49, 2006.  
Hoblyn J, Noda A, Yesavage JA, Brooks JO, Sheikh J, Lee T, Tinklenberg J, Schneider B, O'Hara R, Leslie DL, Rosenheck 
RA, Kraemer HC: Factors in choosing atypical antipsychotics: Toward understanding the bases of physician's 
prescribing decisions. Journal of Psychiatric Research 40: 160-166, 2006.  
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA.: Caution regarding the use of pilot studies to guide power 
calculations for study proposals. Arch Gen Psychiatry 63: 484-9, 2006.  
Neylan TC, Lenoci M, Samuelson KW, Metzler TJ, Henn-Haase C, Hierholzer RW, Lindley SE, Otte C, Schoenfeld FB, 
Yesavage JA, Marmar CR: No improvement of posttraumatic stress disorder symptoms with guanfacine treatment. Am 
J Psychiatry 163: 2186-8, 2006.  
Noda A, Kraemer HC, Taylor JL, Schneider B, Ashford JW, Yesavage JA: Strategies to reduce site differences in multi-site 
studies of rapid cognitive decline among Alzheimer's patients. American Journal of Geriatric Psychiatry 14: 931-938, 
2006.  
Ota KS, Friedman L, Ashford JW, Hernandez B, Penner A, Stepp AM, Raam R, Yesavage JA: The Cost-Time Index: A new 
method for measuring the efficiencies of recruitment resources in clinical trials. Contem Clin Trials 27: 494-7, 2006.  
Steffens DC, Otey E, Alexopoulos GS, Butters MA, Cuthbert B, Ganguli M, Geda Y, Hendrie HC, Krishnan RR, Kumar A, 
Lopez OL, Lyketsos CG, Mast BT, Morris JC, Norton MC, Peavy GM, Petersen RC, Reynolds CF, Salloway S, Welsh-
Bohmer KA, Yesavage JA: Perspectives on depression, mild cognitive impairment, and cognitive decline. Archives of 
General Psychiatry 63: 130-138, 2006.  
Yesavage JA, Sheikh JS, Noda A, Murphy G, O'Hara R, Hierholzer R, Battista M, Ashford JW, Schnieder B, Hoblyn J, 
Kraemer HC, Tinklenberg JR: Spatial test of the effects of agricultural pesticide "blow on" effect on prevalence of 
Parkinson's disease. Journal of Geriatric Psychiatry and Neurology 19: 32-35, 2006.  
Aulakh JS, Hawkins JW, Athwal HS, Sheikh JI, Yesavage J, Tinklenberg JR: Tolerability and effectiveness of lamotrigine in 
complex elderly patients. J Geriatr Psychiatry Neurol 18 (1):8-11, 2005 
Wisor J, Edgar D, Yesavage J, Ryan H, McCormick C, Lapustea N, Murphy GM: Sleep and circadian abnormalities in a 
transgenic mouse model of Alzheimer's disease: A role for cholinergic transmission. Neuroscience 131:375-385, 2005 
Benson K, Friedman L, Noda A, Wicks D, Wakabayashi E, Yesavage J: The measurement of sleep by actigraphy: direct 
comparison of 2 commercially available actigraphs in a nonclinical population. Sleep27(5):986-9, 2004 
Newkirk LA, Kim JM, Thompson JM, Tinklenberg JR, Yesavage JA, Taylor JL: Validation of a 26-point telephone version of 
the Mini-Mental State Examination. J Geriatr Psychiatry Neurol17(2):81-7, 2004 

 
_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix C – Curricula Vitae 
 
C-3 
Rosen C, Chow H, Finney H, Greenbaum M, Moos R, Sheikh  J, Yesavage J: VA practice patterns and practice guidelines 
for treating posttraumatic stress disorder. Traumatic Stress17(3):213-222, 2004 
Yesavage J, Sheikh J, Noda A, Murphy G, O'Hara R, Hierholzer R, Battista M, Ashford W, Kraemer H, Tinklenberg J: Use 
of a VA pharmacy database to screen for areas at high risk for disease: Parkinson's Disease and exposure to peticides. 
J Geriatr Psychiatry Neurol17 (1):36-38, 2004 
Yesavage JA, Friedman L, Kraemer H, Tinklenberg JR, Salehi A, Noda A, Taylor JL, O'Hara R, Murphy G: Sleep/wake 
disruption in Alzheimer's disease: APOE status and longitudinal course. J Geriatr Psychiatry Neurol 17(1):20-4, 2004 
Brooks JO, 3rd, Friedman L, Yesavage JA: Use of an external mnemonic to augment the efficacy of an internal mnemonic 
in older adults. Int Psychogeriatr15(1):59-67, 2003 
Mumenthaler MS, Yesavage JA, Taylor JL, O'Hara R, Friedman L, Lee H, Kraemer HC: Psychoactive drugs and pilot 
performance: a comparison of nicotine, donepezil, and alcohol effects. Neuropsychopharmacology 2003; 28:1366-73 
Fountoulakis KN, O'Hara R, Iacovides A, Camilleri CP, Kaprinis S, Kaprinis G, Yesavage J: Unipolar late-onset depression: 
A comprehensive review. Annals of General Hospital Psychiatry 2003; 2(1):11 
Rosen AC, Prull MW, Gabrieli JD, Stoub T, O'Hara R, Friedman L, Yesavage JA, deToledo-Morrell L: Differential 
associations between entorhinal and hippocampal volumes and memory performance in older adults. Behav Neurosci 
2003; 117(6):1150-60 
Yesavage J, Hoblyn J, Sheikh J, Tinklenberg J, Noda A, O'Hara R, Fenn C, Mumenthaler M, Friedman L, Kraemer H: Age 
and disease severity predict choice of atypical neuroleptic: a signal detection approach to physicians' prescribing 
decisions. Journal of Psychiatric Research 2003; 37(6):535-8 
Yesavage JA, Friedman L, Ancoli-Israel S, Bliwise D, Singer C, Vitiello MV, Monjan AA, Lebowitz B: Development of 
diagnostic criteria for defining sleep disturbance in Alzheimer's disease. Journal of Geriatric Psychiatry and Neurology 
2003; 16(3):131-9 
Coman E, Moses JA, Jr., Kraemer HC, Friedman LF, Benton AL, Yesavage JA: Interactive influences on BVRT 
performance level: Geriatric considerations. Archives of Clinical Neuropsychology 2002; 17:595-610 
Ford JM, Askari N, Gabrieli JD, Mathalon DH, Tinklenberg J, Menon V, Yesavage J: Event-related brain potential evidence 
of spared knowledge in Alzheimer's disease. Psychology and Aging 2002; 16(1):161-76. 
O'Hara R, Tinklenberg J, Thompson J, Fenn C, Taylor J, Ross L, Yesavage J, Kraemer H: Which Alzheimer patients are at 
risk for rapid cognitive decline? Journal of Geriatric Psychiatry and Neurology 2002; 15:1-6 
O'Hara R, Yesavage JA: The Geriatric Depresssion Scale: It's development and recent application, in Principles and 
Practice of Geriatric Psychiatry. Ed Copeland J, Abou-Saleh M, Balzer D. Sussex, Wiley & Sons, 2002 
Rosen A, Prull M, O'Hara R, Race E, Desmond J, Glover G, Yesavage J, Gabrieli J: Variable effects of aging on frontal 
lobe contributions to memory. Neuroreport 2002; 13(18):2425-2428 
Rosen AC, Bokde AL, Pearl A, Yesavage JA: Ethical, and practical issues in applying functional imaging to the clinical 
management of Alzheimer's disease. Brain and Cognition 2002; 50(3):498-519 
Rosen C, Chow H, Greenbaum M, Finney J, Moos R, Sheikh J, Yesavage J: How well are clinicians following dementia 
practice guidelines? Alzheimer's Disease and Associated Disorders 2002; 16:15-23 
Taylor JL, Kraemer HC, Noda A, Friedman L, Zarcone V, Tinklenberg JR, Yesavage JA: On disentangling states versus 
traits: Demonstration of a new technique using the Alzheimer's Disease Assessment Scale. Alzheimer's Disease and 
Associated Disorders 2002; 16(4):254-60 
Taylor JL, Mumenthaler MS, Kraemer HC, Noda A, O'Hara RM, Yesavage JA: Longitudinal study of older small-aircraft 
pilots: Changes in CogScreen-AE performance, in Proceedings of the 11th International Symposium on Aviation 
Psychology. Edited by Jensen RS. Columbus, Ohio, Ohio State University, 2002 
Yesavage J, Mumenthaler M, Taylor J, Friedman L, O'Hara R, Sheikh J, Tinklenberg J, Whitehouse PJ: Donepezil and 
flight simulator performance: Effects on retention of complex skills. Neurology 59(1):123-5, 2002 
Yesavage JA, O'Hara R, Kraemer H, Noda A, Taylor JL, Ferris S, Gely-Nargeot MC, Rosen A, Friedman L, Sheikh J, 
Derouesne C: Modeling the prevalence and incidence of Alzheimer's disease and mild cognitive impairment. J 
Psychiatr Res 36(5):281-6, 2002 
Yesavage JA, Taylor JL, Kraemer HC, Noda A, Friedman L, Tinklenberg JR: Sleep/wake cycle disturbance in Alzheimer's 
disease: How much is due to an inherent trait? International Psychogeriatrics 14(1):73-81, 2002 
Mumenthaler MS, O'Hara R, Taylor JL, Friedman L, Yesavage JA: Influence of the menstrual cycle on flight simulator 
performance after alcohol ingestion. Journal of Studies on Alcohol 62(4):422-433, 2001 
 

 
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C. Research Support 
List selected ongoing or completed (during the last three years) research projects (federal and non-federal support). Begin with the projects that 
are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and your role (e.g. PI, Co-
Investigator, Consultant) in the research project. Do not list award amounts or percent effort in projects. 
 
AG 17824 (PI: Yesavage, Jerome A. ) 
9/1/2000 - 4/30/2006 
NIA 
 Role: Center Director 
Stanford NIA Alzheimer's Disease Core Center 
The focus of our Center is the study of aspects of the heterogeneity of AD, including etiology; progression of disease; and 
pathophysiology of associated behavioral symptoms.  This research is closely integrated with major research programs in 
basic neurosciences and genetics, neuroimaging, and sleep/chronobiology.  We foster research efforts that bridge 
disciplines and increase cross-fertilization of ideas.  
(no project number) (PI: Yesavage, Jerome A. ) 
1/1/2005 - 12/31/2010 
Department of Veterans Affairs 
Role: Principal Investigator 
PTSD, Sleep Apnea, and APOE Genotype: Effects on Cognition 
To examine whether sleep-disordered breathing, APOE status, increasing age and their interactions will predict rate of 
cognitive decline in veterans who have PTSD, a population already at risk for cognitive deficits.   
MH 35182 (PI: Yesavage, Jerome A. ) 
2/1/1984 - 6/30/2006 
NIMH 
Role: Principal Investigator 
Memory and Mental Health in Aging 
A study of methods to help elderly persons improve memory, especially for names and faces, lists, and reading.  Various 
training methods, with and without donepezil, will be compared. 
AG 12713 (PI: Yesavage, Jerome A. ) 
9/10/1995 - 6/30/2006 
NIA 
Role: Principal Investigator 
Age-Related Longitudinal Changes in Aviator Performance 
Longitudinal study of changes in performance among aviators 50 to 70 to evaluate effects of age on performance over time.  
AG 12914-07 (PI: Yesavage, Jerome A. ) 
9/1/1990 - 1/31/2006 
NIA 
 Role: Principal Investigator 
Treatments for Insomnia 
A comparison of the efficacy of  nonhypnotic treatments for insomnia: a behavioral treatment that using sleep hygiene to 
improve sleep; and timed exposed to bright light in addition to sleep hygiene principles.   
 (no project number) (site PI: Yesavage, Jerome A.)) 
7/1/2002 - 7/31/2005 
HealthCare Technology Systems, Inc. / NIH 
Role: site Principal Investigator 
Assessing Cognition: Interactive Voice Response Systems 

 
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Test a computer-automated method, using IVR technology, to obtain data on measuring treatment efficacy in clinical trials. 
AG024904 (PI: Weiner, Michael ; site PI Yesavage, Jerome A.) 
9/30/2004 - 9/29/2009 
NIA 
Role: site Principal Investigator 
Alzheimer’s Disease Neuroimaging Initiative 
The goals are to: 1) Develop improved methods for acquiring longitudinal, multi-site MRI and PET data on patients with 
AD, MCI, and elderly controls. 2) Acquire a data repository describing longitudinal changes in brain structure and 
metabolism. 3) Determine methods which provide maximum power to determine treatment effects. 
98-01 (site PI: Yesavage, Jerome A.) 
2/1/2002 - 1/31/2006 
NIA/Alzheimer’s Disease Cooperative Studies 
Role: site Principal Investigator 
Healthy Aging and Memory 
Deveolopment and testing of efficient, cost effective measures designed for use in AD primary prevention trials.   
98 HC (site PI: Yesavage, Jerome A.) 
2/1/2003 - 3/9/2006 
NIA/Alzheimer’s Disease Cooperative Studies 
Role: site Principal Investigator 
High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimer’s Disease (VITAL) 
To determine is reducing the blood level of homocysteine affects the progression of Alzheimer’s Disease. 
98AX (site PI: Yesavage, Jerome A.) 
6/1/05 – 6/30/06 
NIA/Alzheimer’s Disease Cooperative Studies 
Role: site Principal Investigator 
Evaluation of the Safety, Tolerability, and Impact on Biomarkers of Antioxidant Treatment of Mild to Moderate 
Alzheimer’s Disease 
The goal of this trial is to assess the effect on biomarkers related to oxidative damage two antioxidant treatments in patients 
with mild to moderate AD.  
98 VP (site PI: Yesavage, Jerome A.) 
7/1/03 – 6/30/06 
NIA/Alzheimer’s Disease Cooperative Studies 
Role: site Principal Investigator 
Valproate in Dementia (VALID) 
This is a multi-site, randomized, placebo-controlled clinical trial looking at the effects of valproate on Alzheimer’s Disease.
98-00 (site PI: Yesavage, Jerome A.) 
12/1/2002 – 12/31/05 
NIA/Alzheimer’s Disease Cooperative Studies 
Role: site Principal Investigator 
Cholesterol-Lowering Agent to Slow the Progression of Alzheimer's Disease (CLASP) 
This is a multi-site, randomized, placebo-controlled trial to determine if simvastatin has an effect on the progression of AD.
NAMMD15 (Yesavage) 
2/1/2003 – 12/31/2007 

 
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Forest Research Institute 
Role: Principal Investigator 
The Effect of Memantine on Brain Structure and Chemistry in alzheimer’s Disease Patients: A Randomized, Placebo-
Controlled, 52-Week Clinical Trial 
MRI scans before and after treatment with Memantine will be compared. 
AG 16976 (site PI: Yesavage, Jerome A.) 
7/1/2000 - 6/30/2006 
NIA: University of Washington 
 Role: site Principal Investigator 
NACC Minimum Data Set 
This project contributes data from the Stanford AD Core Center to the National Alzheimer Coordinating Center. 
AG 18784 (PI: O'Hara, Ruth M.) 
9/30/2001 - 8/31/2006 
NIH 
Role: Investigator 
Stress, Cortisol, and Cognitive Decline in Older Adults(PI: O’Hara); part of  Stress, the HPA and Health in Aging (PI: 
Spiegal) 
To determine if levels of stress, as measured by cortisol levels, affects cognitive decline in older adults. 
AG 21134 (PI: Sheikh, Javaid I. ) 
2/1/2004 - 1/31/2009  
NIA 
Role: Investigator 
Light Treatment for Sleep/Wake Disturbances in AD 
To compare short-term efficacy of 2 treatments for sleep/wake cycle disturbances in community-dwelling AD patients:  a) 
Bright light treatment and b) Dim light treatment. Outcome measures are circadian rhythm parameters and actigraphy. 
AG 021632 (PI: Joy Taylor) 
8/15/2003 - 7/31/2008 
NIA 
Role: Investigator  
MRI and Decline of Aging Aviator Performance 
To determine if one can improve models of age-related decline on a “real world” cognitive task by adding assessments of 
longitudinal brain volume changes to the model. Half of the sample will possess an Apolipoprotein E (APOE) epsilon 4 
allele (e4 carriers), a genetic risk factor for Alzheimer’s disease. 
03-75273 (PI: Jared R. Tinklenberg) 
07/01/2003 - 06/30/2006 
State of California  
Role: Investigator  
Stanford/VA Alzheimer's Disease Research Center of California (ARCC) 
This project is a California State Alzheimer's Disease Research Center of California (ARCC). The funding helps provide 
for diagnostic services, as well as some caregiver and referral services to Alzheimer's patients and their families; and to 
collect epidemiologic data on Alzheimer's patients and their caregivers. 
 
D. Time and Effort Statement 
Indicate percentage of time spent on research, clinical, teaching/mentoring, and administration.  List persons mentored in last 3 years and type of 
mentoring awards. 
Dr. Yesavage's effort is distributed: 67% of his time on his VA appointment and 33% on his Stanford University 
appointment.   His VA appointment is distributed: 10% on Clinical, 25% on Administration, 7% on Teaching, and 25% on 
Research.  His Stanford University appoinment is distributed: 23% on Research and 10% on Others.   

 
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The following persons have been mentored over the last three years:   
2003-2005 
M. Bret Schnieder VA MIRECC Fellowship 
2003-2002 
Eric Wexler   VA MIRECC Fellowship 
 
E. Significant Life Events (OPTIONAL) 
List any significant life events that have interrupted the PI’s research activities for a significant period of time. 
 
      
 
 
 
 

 
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APPENDIX D 
BIOSTATISTICAL AND RESEARCH DATA  
PROCESSING PROCEDURE (BRDP)

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I.  INTRODUCTION 
 
This study will evaluate the efficacy, safety, durability of benefit and cost-
effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of 
Treatment-Resistant Major Depression (TRMD) with emphasis on the unique population 
served by the VA Healthcare System.  
II. STUDY MANAGEMENT AT THE CSPCC
 
A CSPCC study team has been formed to ensure that the study is conducted both 
efficiently and professionally and that the study investigators are provided with all of the 
assistance that they need for the successful completion of the study.  This team is 
composed of a Biostatistician, Project Manager, Statistical Programmer, Database 
Programmer, and one Computer Assistant.  Other core staff at the CSPCC, such as 
Program Assistants, Travel Clerks, Computer Operators, and Print Machine Operator 
will provide help as required.  The study team assigned to this study is composed of: 
 Biostatistician
Dr. Kousick Biswas 

Project Manager
Ms. Heather Buckland 

Statistical Programmer
Ms. Anne Horney 

Database Programmer
Mr. Joseph Tadalan 

Computer Assistant
Ms. Brittany Coker 
 
The Biostatistician is the study team leader and has the overall responsibility for the 
conduct of the study at the CSPCC.  He is the CSPCC’s representative to the Study 
Group and will also serve on the study’s Executive Committee.  He is responsible for 
providing the Study Group with statistical and clinical trial advice, for working with other 
CSPCC team members in the preparation of routine interim reports, and for conducting 
the final analyses at the end of the study. The Biostatistician has the overall 
responsibility for the validation of the study database and for implementing quality 
control procedures to reduce data errors in the study database.  

 
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The Project Manager is responsible for the administrative coordination of the study 
at the CSPCC.  She serves as the Biostatistician’s Administrative Assistant and works 
with the CSPCC study team to ensure that all reports, study materials, and meeting 
arrangement notices are sent to the proper individuals in a timely fashion.  She will work 
closely with the National Study Coordinator in the Chairman’s Office to ensure that the 
study runs smoothly and will be in contact with the Nurse Practitioners and the Study 
Coordinators at the participating centers at least monthly to discuss any problems that 
they may be having, including those with the CSPCC.  She will also work with the R&D 
Offices at the participating sites, obtaining initial and continuing reviews by the Central 
IRB and by local Human Studies Subcommittees/IRBs and local Research and 
Development Offices.  She also works with the Chairman’s Office in the preparation of 
the study budget.   
 
 
The Statistical Programmer is responsible for the preparation of the tables and 
analyses for all interim and summary study reports.  These include reports for the Study 
Group, the Executive Committee, the Data and Safety Monitoring Board, and the 
Human Rights Committee as well as the mid-study report to Cooperative Studies 
Scientific Evaluation Committee (CSSEC).  He also prepares the tables and reports for 
the final analyses.  He works with the Biostatistician in the performance of the statistical 
analysis of the data.   
 
 
The Database Programmer is responsible for establishing and maintaining the 
study’s database.  In addition, he will write a set of computer edits that will thoroughly 
check the data for errors and missing information.  He will prepare monthly reports 
regarding the quality and quantity of data submitted to the CSPCC. 
 
      The Computer Assistant is responsible for training the study staff at each site on 
how to properly manage the data collection process and how to appropriately respond 
to data edits.  All data will be edited.  If incomplete or inaccurate data are found, data 
queries will be generated.  The computer assistant will work with each site to resolve 
these queries.   

 
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III.  DATA MANAGEMENT 
 
 
The data flow and management process for the study is given in Figure 1.  When 
a participating site has a study participant ready to be randomized, the Site Investigator 
(SI) or the Study Coordinator (SC) will open the randomization form.  If all eligibility 
checks are passed, randomization software will determine the participant’s treatment 
group assignment. A unique treatment number associated with this treatment group 
assignment will be provided to the site for this participant and will be used by the 
treatment software to provide the appropriate (active or sham) treatment for the 
participant. 
 
Data forms have been developed for collecting study data and samples can be 
found in Appendix E of the protocol.  Table 2 in protocol section VI.G lists the case 
report forms and the assessments that will be used in this study and indicates when 
each will be administered.  The SI, the TMS Treater, or the Study Coordinator at each 
participating site will either record patient data on the study forms or enter data directly 
into the InfoPath form templates.  All data will be submitted using InfoPath and the 
study’s SharePoint website.  The final responsibility for the completeness and accuracy 
of all study data collected at a participating site resides with the SI who will electronically 
sign all submitted data.   
 
 
 
 
 
 

 
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FIGURE 1.  Data Flow for CSP #556, “The Effectiveness of rTMS in 
Depressed VA Patients” 
 
Eligible Patient 
Patient Randomized 
 
Clean Data is stored on the 
SharePoint Website 
  
Data Collection Forms 
Submitted via SharePoint 
Website 
 
SharePoint/InfoPath  
Edits Data  
Data 
Corrections 
will be posted 
on SharePoint 

 
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The study database will be continuously updated with new data and changes to 
previously submitted data.  Study and form-specific computer software will be used to 
edit data for completeness, accuracy, and consistency.  Queries will be generated that 
identify missing, inconsistent, or extremely unusual data on individual forms, as well as, 
missing or late forms.   
 
 
In addition, a summary report of all data submitted and problems identified will be 
generated for each participating site.  This report will provide each site with a summary 
of their progress.   
 
 
In addition to the SI reviewing the data prior to being submitted and the 
computerized editing, the Biostatistician will perform a qualitative review and compare a 
random sample of submitted data from the database with the actual study forms or 
source documents on a routine basis.  The National Study Coordinator in the 
Chairman’s Office will also be reviewing each site’s progress to ensure that there are no 
unforeseen problems with the forms or with a particular patient. 
 
 
Another mechanism used to monitor the data and the progress of the study will 
be the preparation of periodic reports to various groups that are responsible for 
overseeing the conduct of the study.  These groups include the Study Group, the 
Executive Committee, the Data and Safety Monitoring Board, and the CSPCC Human 
Rights Committee.  These groups will receive study progress reports prior to their 
annual meetings and at least once in between their annual meetings.  Thus, on 
average, these groups will receive a report every six months.  The contents of these 
reports are discussed in the remainder of this appendix. 
 
IV.  MONITORING OF STUDY BY STUDY GROUP AND EXECUTIVE COMMITTEE 
 
 
The Study Group (all of the SIs) and Executive Committee will meet 6 to 9 
months after patient recruitment begins and at annual intervals thereafter until the end 
of the study.  Three weeks prior to these meetings and at 6-month intervals between the 

 
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meetings, these groups will be provided a report that will allow them to assess study 
progress.  Since both groups are composed of study participants, no outcome data 
(data that would potentially break the study blind) will be provided in these reports.  The 
information provided will include data on: 
 
A. 
Screening, enrollment, and retention 
B. 
Patient background characteristics at entry 
C. 
Data quality and protocol adherence. 
 
A.  Screening, Enrollment and Retention 
 
 
The study team at each site will identify patients who might be candidates for the 
study.   After the study has been explained to the patient and the patient signs the 
informed consent form, the screening process can be initiated.  The study team will 
complete the screening forms.  If the patient meets all eligibility criteria, baseline forms 
will be completed.  The patient can then be randomized using the study’s randomization 
software which will assign to the patient a unique treatment number.   
 
The progress of patient accrual will be presented to the monitoring groups in 
three formats: 
1. 
In the first format, the study progress is presented: 
 by site 
 by the actual number of patients entered into the study 
(randomized) 
 by the expected number of patients to be entered at the time of the 
report – high intake rate 
 by the percent of expected that were entered – high intake rate 
 by the expected number of patients to be entered at the time of the 
report – low intake rate 
 by the percent of expected that were entered – low intake rate 
 

 
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This format, as demonstrated in Table 1, will allow the Executive Committee to 
determine which sites are not recruiting as expected and the SIs to see how their 
site is doing in comparison with the others.   
 
2. 
In the second format, as demonstrated in Table 2, the study progress is 
presented by the number of patients entered into the study (randomized) by 
month.  These data will be organized by site.  The data will indicate if recruitment 
is improving or worsening over time at the various sites.  Sites where intake is 
worsening can be detected and the SI can be contacted to identify the reason for 
the recruitment deficit.  
 
3. 
In the final format, intake data will be plotted over time for the total number 
of patients recruited as shown in Figure 2.  Both high and low expected intake 
lines are given for comparison purposes assuming constant enrollment rates.  
The high enrollment rate is 1.5 patients per month per site and the low enrollment 
rate is 1.1 patients per month per site.  The number of patients screened and the 
number of those that enroll in the study will be presented in Table 3.  The 
reasons for the exclusion of screened patients will be presented in Table 4. 
 
 
 
 
 
 
 
TABLE 1.  Number Of Patients Entered Into CSP #556 And Number Expected 
 
Site 
Number 
Enrolled 
 
Number Expected 
 
Percent of Expected 
Low Intake 
High Intake 
Low Intake 
High Intake 

 
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1 
2 
. 
. 
. 
9 
 
 
 
 
 
TOTAL 
 
 
 
 
 
 
 
 
 
TABLE 2.  Number Of Patients Entered Each Month Into CSP #556 By Site 
 
Month 
Site 1 
Site 2 
... 
Site 9 
01/09 
02/09 
. 
. 
. 
 
 
 
 
 
TOTAL 
 
 
 
 
 
 
 
 
 

 
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0
60
120
180
240
300
360
0
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
Months
Number Enrolled
 
 
. 
 
TABLE 3.  Cumulative Screening Summary:  All Patients by Site 
 
 
Site 
Screened 
Rejected 
Enrolled 
% Rejected 
1 
2 
3 
. 
. 
. 
9 
 
 
 
 
TOTAL 
 
 
 
 
 
 
FIGURE  2.  Observed Versus Expected Patient Recruitment in CSP #556 

 
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TABLE 4.  Summary of Ineligibility:  Reasons for Exclusion,  
Total and By Site 
 
TOTAL NUMBER SCREENED = ____________ 
 
Reason 
# Excluded 
% of Screened 
1.  < 18 or  > 80 years of age 
 
 
2.  Negative for MDD on SCID 
 
 
3.    HRSD24 < 20 
 
 
4.   Not Moderately Resistant to Antidepressant 
Treatment 
 
 
. 
 
 
. 
 
 
. 
 
 
21.  Head Injury with Loss of Consciousness > 15 
minutes 
 
 
22.  Participant in Another Clinical Trial 
 
 
23.  Prior Exposure to rTMS 
 
 
24.  Active Current Suicidal Intent or Plan 
 
 
 
B.  Background Characteristics at Entry 
 
 
Background characteristics of the study patients are collected on the Baseline 
Information Form.  Tables summarizing the important background characteristics by site 
will be prepared and submitted to the Study Group so they will have an idea of the 
population being studied and comparisons of enrollment among the sites can be made.  
This information will be presented as means and medians for continuous type variables 
and as frequency tables for discrete variables.  Table 5 shows how this data will be 
presented.  Other variables that are routinely presented include gender, race, ethnicity, 
marital status, military history and work history.  Analysis of variance and chi-square 

 
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techniques will be used to identify any statistically significant differences that may exist 
between the sites. 
 
 
TABLE 5.  Mean and Median Ages by Site for CSP #556 
 
 
 
Site 1 
(N= ) 
Site 2 
(N= ) 
... 
Total 
(N= ) 
  
Age (years) 
mean 
 
s.d. 
 
median 
 
mean
 
s.d.
 
median
 
mean
 
s.d.
 
median 
 
mean 
 
s.d.
 
median
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Gender  
      Male 
n 
 
 
(%) 
 
 
 
n 
 
 
(%)
 
 
 
n 
 
 
(%)
 
 
 
n 
 
 
(%)
 
 
 
      Female 
 
 
 
 
 
 
 
 
C.  Data Quality and Protocol Adherence 
 
 
The final type of information that will be provided to the Site Investigators is data 
that will allow them to assess the quality of the data being submitted and how well their 
site is adhering to the protocol.  These data will be given by site, so sites performing 
substantially below average can be identified and remedial action taken to improve their 
performance. 
 
 
One piece of information that will be routinely provided is the number of forms 
that are missing according to the patient’s assessment schedule.  Table 6 indicates how 
this information will be displayed. 
 
 
In addition to the tables for the reports, the computer editing system produces 
reports that indicate the number of errors that were found on the individual forms.  
These were discussed previously under Section III, Data Management.  Edit reports 
will assist in identifying those sites requiring additional training on forms completion.  A 
monthly report summarizing data submission and problem identification for each site will 

 
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be sent to the Study Chairman so that he can monitor how the participating sites are 
doing. 
 
 
 
TABLE 6.  Number of Missing Forms in CSP #556 
 
# of Patients 
Site 
1 
2 
... 
9 
Total 
Form 01 
 
 
Form 02 
. 
. 
. 
. 
Form 32 
N 
% 
 
N 
% 
. 
. 
. 
N 
% 
 
 
 
 
 
 
 
V.  STUDY MONITORING BY DATA AND SAFETY MONITORING BOARD 
 
 
An independent oversight committee called the Data Monitoring Committee 
(DMC) will monitor study progress.  This committee meets on the same basic schedule 
as the Study Group and Executive Committee, i.e., they will meet at 6 to 9 months after 
the start of patient recruitment and yearly thereafter.  Initially, they will meet once prior 
to the study start-up to acquaint themselves with the study and to establish monitoring 
guidelines.  This committee does not usually meet during the last six months of a study.   
 
 
The major responsibility for the DMC members when they meet is to make a 
recommendation to the Director of the Cooperative Studies Program on whether the 
study should continue or not.  The study could be recommended for termination due to 
poor recruitment, treatment differences so large that it is possible to reach a final 
decision, treatment differences so small that continuation would be irresponsible.  The 

 
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DMC also reviews the participating sites’ performance and makes recommendations on 
them.  Their final responsibility is to review all proposed protocol changes and 
subprotocols and to make recommendations as to their acceptability. 
 
 
In order for the DMC to carry out its responsibilities, the CSPCC Study Team will 
provide the committee with a report approximately three weeks prior to their meetings.  
The report will consist of the tables described previously for the Study Group and 
Executive Committee reports as well as those presenting outcome analyses.  It is the 
responsibility of the CSPCC Study Team to provide the DMC with whatever information 
the Board feels that it needs to successfully monitor the study.  Thus, additional tables 
will be added as required.  In addition to the reports for the yearly meetings, the DMC 
will also be provided with reports between meetings at 6-month intervals. 
 
 
In order for the DMC to make its recommendation for continuation of the study, it 
will be necessary for them to see the analyses for the primary outcome measure every 
time that the report is run and it is possible to calculate the primary outcome measure. 
Periodic monitoring of interim results can significantly affect the probability of making an 
incorrect decision.  A number of formal techniques have been developed for interpreting 
interim results. At the organizational meeting, the DSMB will select the technique that it 
wants to use to monitor the study. Suggested techniques are the Haybittle-Peto and 
Lan-DeMets group sequential boundaries. For the Haybittle-Peto method, a constant z-
statistic is used as the monitoring boundary. The Lan-DeMets procedure produces 
decision boundaries that are quite conservative over the first several looks and then 
gradually converages to the nominal alpha levels as the final look is approached.  
Figure 3 gives an example of the Lan-DeMets boundaries for five looks at an alpha 
level of 0.05 

 
_______________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients 
Version 4.3, September  2014 
Appendix D, BIOSTATISTICAL AND RESEARCH DATA  PROCESSING PROCEDURE 
 
D-14 
 
 
 
 
The patient characteristics by site that are given to the Investigators will also be 
considered by treatment group by the DMC.  Differences between treatment groups on 
these patient characteristics may indicate a need to use any significantly different 
characteristics as covariates for the outcome measures.  Formal testing of the 
differences between treatment groups will be done at the study’s conclusion.  Analyses  
of variance techniques will be used to test characteristics that are continuous in nature, 
while chi-square techniques will be used for the discrete variables.   
 
 
As with any clinical trial, the safety of the patient will be of utmost concern.  
Safety will be monitored closely during the course of the study and the adverse event 
data will be reported in the primary study manuscript.  Data will be collected on adverse 
events throughout the study.  The DSMB Report will include data on incidence of 
adverse events by treatment group.  It will also include data on early terminations and 
treatment dropouts. 
 
 
Analysis of the primary outcome is discussed in the Statistical Section of the 
protocol.  In addition to the primary outcome, the protocol lists a number of other 
outcome measures that will be considered.  These include: 
 
-6
-4
-2
0
2
4
6
1
2
3
4
5
Z Test Statistic Value
Looks
Figure 3.  Lan De - Mets Group Sequential Monitoring Boundaries

 
_______________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients 
Version 4.3, September  2014 
Appendix D, BIOSTATISTICAL AND RESEARCH DATA  PROCESSING PROCEDURE 
 
D-15 
 
 
1.  Depression measured by Montgomery-Asberg Depression Rating  
  
 
     Scale, (MADRS) 
 
2.  Suicide Ideation measured by Beck Scale for Suicide Ideation  
     (BSS) 
 
3.  Depression measured by Beck Depression Inventory (BDI) 
 
4.  Previous antidepressant medication use measured by Antidepressant  
   
               Treatment History Form (ATHF) 
 
5.  Quality of Life measured by the VR-36 
 
6.  Cognitive Function as measured by the Neuropsychological  
          Battery  
 
 

APPENDIX E
CASE REPORT FORMS 
(CRFs)

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
MM  
DD 
YYYY 
RETAIN AS SOURCE DOCUMENT; DO NOT DISCARD 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 00_Version 4.1_02212014 
Page 1 of 2 
FORM 00 - CONTACT INFORMATION  
(Complete on all patients who are enrolled in the study. Update as needed.  File this form in the patient’s study 
file.  Do NOT submit this form to Perry Point CSPCC or Palo Alto Chairman’s Office.) 
A. PATIENT INFO: 
___________________________________________________________________ 
Patient Name 
___________________________________________________________________ 
Address 
___________________________________________________________________ 
City 
 
 
 
 
               State 
 
 
         Zip Code 
B. Patient SSN __ __ __ - __ __ - __ __ __ __ 
C. Home telephone  (____)_______________  Work telephone (____)_______________ 
Cell telephone  (____)_______________ 
D. Next of Kin: 
_____________________________________________________________________ 
Name 
_____________________________________________________________________ 
Address 
_____________________________________________________________________ 
City 
 
 
 
 
               State 
 
         Zip Code 
(____)____________________________________
Area Code 
 
Home Telephone 
_____________________________________________________________________ 
Relationship to patient 
E. Friend/ Other family member (not living with patient): 
_____________________________________________________________________ 
Name 
_____________________________________________________________________ 
Address 
_____________________________________________________________________ 
City  
 
 
 
 
              State 
 
 
        Zip Code 
(____)____________________________________
Home Telephone 
 
_____________________________________________________________________ 
Relationship to patient 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
                                                       
MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 00_Version 4.1_02212014 
 
Page 2 of 2 
 
F. Primary psychiatrist 
 
_____________________________________________________________________  
Name 
_____________________________________________________________________ 
_____________________________________________________________________ 
City  
 
 
 
 
              State 
 
 
        Zip Code 
(____)____________________________________ 
 
Area Code 
 
Telephone 
 
G. Mental health case manager 
 
Name 
_____________________________________________________________________ 
 
Address 
____________________________________________________________________
City  
 
 
 
 
              State 
 
 
        Zip Code 
(____)____________________________________ 
Area Code 
 
Telephone 
 
 
 
RETAIN AS SOURCE DOCUMENT; DO NOT DISCARD  
 
DO NOT SEND TO CSPCC (SPONSOR)  

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
 
 
              MM            DD                YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 02 _ Version 4.1_02212014 
 
Page 1 of 1 
Form 01 - SCREENING FORM 
 
 
 
 
Date of Screening: __ __/__ __ /__ __ __ __ 
 
MM            DD                YYYY 
 
1. Did patient sign Informed Consent? 
No 
Yes 
a. If no, using the codes below, circle all reason(s) for not consenting patient: 
01 = 
Age 
15 = 
Do not use  
02 = 
MDD  
16 = 
Brain Implant 
03 = 
HRSD24 ≥ 20 
17 = 
Cochlear Implant 
04 = 
Treatment Resistant 
18 = 
CNS Disease 
05 = 
MDD Duration 
19 = 
Psychosis 
06 = 
MT 
20 = 
Bipolar I 
07 = 
Psychiatrist 
21 = 
BOMC 
08 = 
Stable Meds 
22 = 
Substance Abuse 
09 = 
Attend Visits 
23 = 
TBI 
10 = 
Birth Control 
24 = 
Clinical Trials 
11 = 
Informed Consent 
25 = 
Prior rTMS 
12 = 
Pregnant 
26 = 
Suicidal 
13 = 
Seizure Risks 
27 = 
Cardiac Disease 
14 = 
Pacemaker 
28 = 
Refuses Consent 
 
 
29 = 
Other _______________________________ 
 
 
 
 
COMPLETE AT SCREENING ONLY

 
 
 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
                  MM          DD                  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 02 _Version Version 4.1_02212014 
 
 
Form 02 – RANDOMIZATION FORM 
 
 
 
 
1. Please enter this participant’s 5-digit participant number __ __ __ __ __ 
2. Please enter this participant’s four character Alpha Code __ __ __ __ 
3. Was a Safety Plan created for this subject? (circle one) 
 
No 
 
Yes 
4. Please provide the date of the most recent HRSD assessment?  __ __/__ __/__ __ __ __ 
 
Note that the HRSD assessment date cannot exceed 7 days prior to randomization.  MM          DD 
YYYY 
 
5. Please enter this subject’s 2-digit HRSD score __ __ 
6. If female, and of child bearing potential, please provide date of most recent pregnancy test 
    __ __/__ __/__ __ __ __ 
 
 MM 
DD 
 YYYY 
 
7. Does this subject have a history of substance abuse? (circle one)  No  
 
Yes 
8. Has this subject been diagnosed with PTSD? (circle one)    
No   
 
Yes 
9. Date randomized  
__ __ / __ __ / __ __ __ __ 
 
 
 
 
 
    MM             DD                    YYYY 
10. Randomized treatment number assigned by Perry Point  __ __ __ __ __ __  
     
 
 
 
COMPLETE AT RANDOMIZATION ONLY 

 
 
 
 

 VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 03_Version 4.1_02212014 
 
Page 1 of 6 
Form 03 – BASELINE INFORMATION 
 
 
A. 
PARTICIPANT PROFILE 
1. 
Date of birth .......................................................................  __ __ / __ __ / __ __ __ __  
 
 
MM 
DD 
YYYY 
2. 
Sex (Circle One)  .............................................................................................. Male     Female 
 
3. 
Ethnicity (Circle one) 
Spanish, Hispanic or Latino 
 
 
 
 
 
 
 
No, not Spanish, Hispanic, or Latino        
 
 
 
 
 
 
 
NA 
 
4. Race (Circle one answer for each category) 
American Indian or Alaska Native .............................. No      
 Yes  
Not Collected 
Asian .......................................................................... No      
 Yes  
Not Collected  
Black or African-American .......................................... No      
 Yes  
Not Collected 
Native Hawaiian or Other Pacific Islander .................. No      
 Yes  
Not Collected 
White .......................................................................... No  
Yes  
Not Collected 
Refused/unknown ...................................................... No      
 Yes  
Not Collected 
 
5. 
Current Marital status (Circle one answer that applies)    
1. Single 
5. Separated 
2. Married 
6. Living with partner 
3. Widowed 
7. Not Collected 
4. Divorced 
 
 
6. 
Highest Degree or Certification (Circle one answer that applies) 
1. None 
5. Associate Degree 
9. MD, PhD, Law, Dental  
2. GED  
6. RN Diploma 
10.Other (Specify)___________ 
3. H. S. Diploma 
7. Bachelor’s Degree 
11. Not Collected 
4. Voc Tech Diploma 
8. Master’s Degree 
COMPLETE AT SCREENING ONLY 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 03_ Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 2 of 5 
 
B. 
MILITARY HISTORY 
7. 
When did the participant serve? (Circle one answer for each below) 
a. World War I  ................................................................ No 
Yes 
Not Collected 
b. World War II ................................................................ No 
Yes 
Not Collected 
c. Korean conflict  ........................................................... No 
Yes 
Not Collected 
d. Vietnam conflict  .......................................................... No 
Yes 
Not Collected 
e. Gulf War  ..................................................................... No 
Yes 
Not Collected 
f. 
Balkans conflict  .......................................................... No 
Yes 
Not Collected 
g. Afghanistan conflict  .................................................... No 
Yes 
Not Collected 
h. Iraq conflict .................................................................. No 
Yes 
Not Collected 
i. 
Other war/conflict:   ..................................................... No 
Yes 
Not Collected 
 
specify_________________________________________________________     
j. 
Peace time .................................................................. No 
Yes 
Not Collected 
 
8.   Did the participant serve outside the United States? (Circle one)      No 
Yes 
 
9. 
What was the branch of service? (Circle one answer for each category) 
a.    Army ........................................................................... No 
Yes 
Not Collected 
b.    Air Force .................................................................... No 
Yes 
Not Collected 
c.    Navy ........................................................................... No 
Yes 
Not Collected 
d.    Marines  ..................................................................... No 
Yes 
Not Collected 
e.    Coast Guard  .............................................................. No 
Yes 
Not Collected 
f.     National Guard (active duty)  ..................................... No 
Yes 
Not Collected 
g.    Merchant Marine ........................................................ No 
Yes 
Not Collected 
 
C. 
WORK HISTORY 
10. In the past four weeks, did the participant work at a job FOR PAY, even for one hour (Includes 
odd jobs like babysitting, or pick-up work and temporary jobs as well as regular, steady jobs)? 
  
(Circle the correct answer.)  ............................................... No 
Yes 
Not Collected  
 
11. For the job that the participant worked at for the MOST NUMBER OF HOURS in the past four 
weeks, what specifically was the type of job?  (Circle one answer.) 
 
1. Regular, steady job for pay 
3. Self-employed (work at own business) 
 
2. Temporary or odd job for pay 
4. Other (specify)________________________ 
 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 03_ Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 3 of 5 
12. How much money is the participant usually paid, or expects to earn, for this job, BEFORE taxes
 
are taken out and including any tips or commission? 
 
(Whole dollar amount only)  ................................................................................. __ __ __, __ __ __  
 
 
12a. Specify the rate of payment (Circle one answer.) 
 
 
 
1. per hour                                                      4. per month 
 
 
 
 
2. per day                                                       5. per year 
 
 
 
3. per week                                                      
 
13. In the past four weeks, how many TOTAL HOURS did the participant actually work for pay in ALL 
jobs held?  
 
(Do NOT include the hours of any time that you took off from work)? ........................... ___ ___ ___ 
 
14.  How much did the participant earn in ALL jobs held in the past four weeks before taxes were taken 
out, and including tips and commissions?  
 
(Whole dollar amount only)………......................................................... ___ ___ ___, ___  ___ ___ 
 
D. INCLUSION CRITERIA 
(0 = No, 1 = Yes, 2 = Not Screened) 
15. Is the participant between the age of 18 and 80 years of age? ................................................ ____ 
 
16. Does the participant meet the DSM-IV criteria for Major Depression Disorder ........................ ____ 
 
17. Does the participant have a HRSD score of ≥ 20 within 7 days prior to randomization?... ...... ____ 
 
17a.Record HRSD score…….. ........................................................................................... ___  ___ 
 
18. Does the participant exhibit a moderate level of resistance to antidepressant treatment  
episode defined, using the ATHF, as a failure of at least two adequate medication trials in?  ____ 
 
19. Has current episode lasted no more than 10 years?   .............................................................. ____ 
 
19a. Duration?...........................................................................................yr ___ ___  mo. ___ ____ 
 
20. Can a Motor Threshold be determined during screening?  ...................................................... ____ 
 
21. Participant is currently under the care of a VA psychiatrist? .................................................... ____ 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 03_ Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 4 of 5 
 
22. Has participant’s psychotropic medication been stable for at least 4 weeks prior to  
 
randomization?  ........................................................................................................................ ____ 
 
 
23. Is participant willing to remain on a stable medication and current regimen during  
 
acute treatment?.. ..................................................................................................................... ____ 
 
24. Does the participant have a stable place to live that is convenient to reach the VA Medical 
Center with confirmed transportation available?  ...................................................................... ____ 
 
25. If female, does the participant agree to use an acceptable method of birth control?   
         (If male or no childbearing potential, code “2 not screened") ................................................ ____ 
 
26. Did the participant sign the informed consent form?  ............................................................... ____ 
 
E. 
EXCLUSION CRITERIA  
(0 = No, 1 = Yes, 2 = Not Screened) 
27. Is participant pregnant or lactating female (pregnancy test must be completed within 7 days 
prior to randomization)? (If male or no childbearing potential, code “2 not screened") ............. ____ 
 
28. Is the participant unable to be safely withdrawn, at least 2 weeks prior to beginning treatment, 
 
from medications that substantially increase the risk of seizures? ........................................... ____ 
 
29. Does the participant have a cardiac pacemaker? .................................................................... ____ 
 
30. Question 30 has been removed as per protocol version 4.0 approval (it will not been seen in eDC)? .. ____ 
 
31. Does the participant have an implanted device or metal in the brain? ..................................... ____ 
 
32. Does the participant have a cochlear implant? ......................................................................... ____ 
 
33. Does the participant have a mass lesion, increased intracranial pressure, cerebral infarct or 
other active CNS disease, including a seizure disorder? ......................................................... ____ 
 
34. Does the participant have a known current psychosis as determined by DSM-IV or SCID  
 
(Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder? .... ____ 
 
35. Does the participant have a history of known current Bipolar I disorder as determined by the  
 
SCID-I or a history of Bipolar I disorder? .................................................................................. ____ 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 03_ Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 5 of 5 
 
 
36. Does the participant have current amnestic disorder, dementia, BOMC > 10, delirium or other 
cognitive disorder? ................................................................................................................ ____ 
 
37. Does the participant have a current substance abuse problem (not including caffeine or 
nicotine) as determined by positive toxicology screen or by history via SCID, within 3 
months, prior to screening? ..................................................................................................... ____ 
 
38. Does the participant have elevated risk of seizure due to TBI?................................................ ____ 
 
39. Is the participant participating in another treatment research trial? .......................................... ____ 
 
40. Has the participant had a prior exposure to rTMS? .................................................................. ____ 
 
41. Does the participant have an active current suicidal intent or plan?......................................... ____ 
 
42. Is the participant unwilling to follow a safety plan?  .................................................................. ____ 
 
43. Does the participant have unstable Cardiac Disease or recent (<3 months previous) Myocardial  
 
Infarction ................................................................................................................................... ____ 
 
F. 
Eligible 
44. Participant's Eligibility status (circle one)  
1. Eligible to be Randomized   2. Eligible but declined   3. Ineligible 
a. If eligible but declined, please provide reason: _________________________________ 
________________________________________________________________________
IF ANY ANSWERS TO QUESTIONS 15-26 ARE “NO” or ANY QUESTIONS 
27-43 ARE “YES” THEN THE PARTICIPANT IS INELIGIBLE. 
IF ANSWERS TO QUESTIONS 15-26 ARE “YES” AND ANSWERS TO 27-
43 ARE “NO” THE PARTICIPANT IS ELIGIBLE. 

 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __      Participant # __ __ __ __ __      Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
                                                      
 
MM           DD                 YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 04_ Version 4.1_02212014 
Form 04 – MEDICAL HISTORY FORM 
 
 
Medical Condition 
History 
(Please circle one answer) 
If ‘Yes’ or ‘Not Collected’ then 
provide an explanation 
1. Allergies, drug, specify 
___________________________ 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
2. Allergies, other, specify 
___________________________ 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
3. HEENT Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
4. Cardiovascular Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
5. Renal Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
6. Hepatic Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
7. Pulmonary Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
8. Gastrointestinal Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
9. Musculoskeletal Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
10. Neurological Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
11. Psychiatric Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
COMPLETE AT SCREENING ONLY

Site __ __      Participant # __ __ __ __ __      Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
                                                      
 
                   MM         DD               YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 04_Version 4.1_02212014 
 
 
 
 
 
 
 
 
Page 2 of 2 
 
Medical Condition 
History 
If ‘Yes’ or ‘Not Collected’ then 
provide an explanation 
12. Dermatologic Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
13. Metabolic Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
14. Hematologic Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
15. Endocrine Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
16. Genitourinary Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
17. Reproductive System Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
18. Infectious Disease Disorder 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
19. Traumatic Brain Injury 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
19a. If ‘Yes’, MRI Results 
Positive 
Negative 
 
19b. Date __ __/__ __/__ __ __ __ 
19c. Explanation _______________________________________ 
_____________________________________________________ 
20. Other, _______________________ 
No 
Yes 
Not Collected 
__________________________ 
__________________________ 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
Site __ __    
 Participant # __ __ __ __ __     Alpha Code __ __ __ __ 
 Date __ __/__ __ /__ __ __ __ 
MM           DD                YYYY 
Form 05 – PHYSICAL EXAMINATION FORM 
 
 
Date of examination: __ __ / __ __ / __ __ __ __ 
MM                 DD                        YYYY 
A. Vital Signs: 
1. Height: __ __ inches
2. Weight: __ __ __ lbs
3. Temperature (oral): __ __ __ . __ °F
4. Pulse (sitting): __ __ __ beats/minute
5. Blood pressure (mmHg) (sitting): Systolic __ __ __ / Diastolic __ __ __
B. Physical Examination: 
Physical Examination 
Results 
(Please circle one answer) 
If ‘Abnormal’ or ‘Not 
Done’ provide 
explanation          
6. General Appearance
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
7. HEENT
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
8. Heart
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
9. Lungs
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
Circle Visit Below: 
Screening 
Final Treatment Session 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 05_ Version 4.1_02212014  
Page 1 of 2 

Site __ __    
 Participant # __ __ __ __ __     Alpha Code __ __ __ __ 
 Date __ __/__ __ /__ __ __ __ 
MM           DD                YYYY 
Physical Examination 
Results 
(Please circle one answer) 
If ‘Abnormal’ or ‘Not 
Done’ provide 
explanation 
10. Abdomen
(include liver & spleen)
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
11. Lymph Nodes
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
12. Extremities
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
13. Neurologic
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
14. Musculoskeletal
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
15. Skin
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
16. Other, specify
____________________
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
17. Other, specify
____________________
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
18. Other, specify
____________________
Normal 
Abnormal 
Not Done 
_______________________ 
_______________________ 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 05_Version 4.1_02212014  
Page 2 of 2 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __       Participant # __ __ __ __ __      Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
                   MM            DD                  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 06_ Version 4.1_02212014 
 
 
 
 
 
 
Page 1 of 4 
Form 06 – LABORATORY DATA 
 COMPLETE AT SCREENING ONLY 
 
Date Blood Specimen Collected:    
 __ __/__ __/__ __ __ __ 
 
 
 
  MM 
      DD 
        YYYY 
 
A. CBC 
Results 
(Please circle only one) 
If ‘Abnormal’ or 
‘Not Done’ 
provide Comment 
1. RBC 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
2. WBC 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
3. Hemoglobin 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
4. Hematocrit 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
5. Platelet Count 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
6. Other specify 
____________ 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________

Site __ __       Participant # __ __ __ __ __      Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
                   MM            DD                  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 06_Version 4.1_02212014 
 
 
Page 2 of 4 
 
B. CHEMISTRY 
Results 
(Please circle only one) 
If ‘Abnormal’ or 
‘Not Done’ 
provide Comment 
7. Sodium 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
8. Potassium 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
9. Chloride 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
10. CO2 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
11. Glucose 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
12. Creatinine 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
13. BUN/Urea 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
14. Other specify 
_____________ 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________

Site __ __       Participant # __ __ __ __ __      Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
                   MM            DD                  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 06_Version 4.1_02212014 
 
 
Page 3 of 4 
 
C. LIVER PANAL 
Results 
(Please circle only one) 
If ‘Abnormal’ or 
‘Not Done’ 
provide Comment 
15. Albumin 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
16. Total Bilirubin 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
17. Direct Bilirubin Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
18. AST 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
19. ALT 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
20. ALP 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
21. Total Protein 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
22. Other specify 
_____________ 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________

Site __ __       Participant # __ __ __ __ __      Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
                   MM            DD                  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 06_Version 4.1_02212014 
 
 
Page 4 of 4 
 
D. ENDOCRINE 
Results 
(Please circle only one) 
If ‘Abnormal’ or 
‘Not Done’ 
provide Comment 
23. TSH 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
24. Total T3 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
25. Total T4 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
26. Other specify 
_____________ 
Normal 
Abnormal Not 
Clinically 
Significant 
Abnormal 
Clinically 
Significant 
Not 
Done 
________________
________________
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
          MM          DD 
      YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 07_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 1 of 2 
Form 07 - SCID 
 
 
DX 
 
  
 
 
Meets Symptomatic 
Code 
Diagnosis (Module Section) 
Lifetime Prevalence 
 
Dx. Crit. past  Month  
 
 
 
 
Sub- 
 
 
Absent 
Threshold Threshold 
Absent 
Present 
 
 
MOOD DISORDERS 
 
 
 
 
 
 
 
01 
Bipolar I Disorder (D.1) 
 
1 
2 
3 
1 
3 
02 
Bipolar II Disorder (D.2) 
 
1 
2 
3 
1 
3 
03 
Other Bipolar Disorder (D.5) 
 
1 
2 
3 
1 
3 
04 
Major Depressive Disorder (D.6) 
1 
2 
3 
1 
3 
05 
Dysthymic Disorder (A.41) 
 
1 
2 
3 
1 
3 
06 
Depressive Disorder NOS (D.9)  
1 
 
3 
1 
3 
07 
Mood Disorder Due to a General 
1 
 
3 
1 
3 
 
Medical Condition (A.44) 
 
08 
Substance-Induced Mood  
 
1 
 
3 
1 
3 
 
Disorder (A.46) 
 
 
 
PSYCHOTIC SYMPTOMS 
 
 
 
 
 
 
 
09 
Primary Psychotic Symptoms  
1 
2 
3 
1 
3 
 
(not part of Mood Disorder) (B/C.4) 
 
 
SUBSTANCE USE DISORDER 
 
(Abuse/Dependence)                           
 
 
 
 
 
17 
Alcohol (E.3/E.6) 
 
1 
2 
3 
1 
3 
18 
Sedative-Hypnotic-Anxiolytic   
1 
2 
3 
1 
3 
 
(E.12/E.15) 
 
19 
Cannabis (E.12/E.15) 
 
1 
2 
3 
1 
3 
20 
Stimulants (E.12/E.15) 
 
1 
2 
3 
1 
3 
21 
Opioid (E.12/E.15) 
 
1 
2 
3 
1 
3 
 
COMPLETE AT SCREENING ONLY 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
          MM          DD 
      YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 07_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 2 of 2 
DX 
 
  
 
 
Meets Symptomatic 
Code 
Diagnosis (Module Section) 
Lifetime Prevalence 
 
Dx. Crit. past  Month  
 
 
 
 
Sub- 
 
 
Absent 
Threshold  Threshold 
Absent 
Present 
 
 
SUBSTANCE USE DISORDER 
 
(Abuse/Dependence) Continued        
 
 
 
 
 
22 
Cocaine (E.12/E.15) 
 
1 
2 
3 
1 
3 
23 
Hal./PCP (E.12/E.15) 
 
1 
2 
3 
1 
3 
24 
Poly Drug (E.15) 
 
1 
2 
3 
1 
3 
25 
Other (E.22/E.16) 
 
1 
2 
3 
1 
3 
 
 
ANXIETY DISORDERS 
 
 
 
 
 
 
 
26 
Panic Disorder With/Without 
 
1 
2 
3 
1 
3 
 
Agoraphobia (F.3) 
27 
Agoraphobia Without History 
 
1 
2 
3 
1 
3 
 
 
of Panic Disorder (F.9) 
28 
Social Phobia (F.14) 
 
1 
2 
3 
1 
3 
29 
Specific Phobia (F.18) 
 
1 
2 
3 
1 
3 
30 
Obsessive Compulsive 
 
1 
2 
3 
1 
3 
 
 
Disorder (F.23) 
31 
Posttraumatic Stress (F.29) 
 
1 
2 
3 
1 
3 
32 
Generalized Anxiety Disorder (F.34) 1 
2 
3 
1 
3 
33 
Anxiety Disorder Due to a General 
1 
 
3 
1 
3 
 
Medical Condition (F.37) 
34 
Substance-Induced Anxiety 
 
1 
 
3 
1 
3 
 
Disorder (F.39) 
35 
Anxiety Disorder NOS (F.40) 
 
1 
 
3 
1 
3 
 
 
 
 
 
 
 
 
 
SC/TT Signature ________________________________________              Date ____________________ 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __       Participant # __ __ __ __ __       Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
                                                       
 
 
 
 
 
           MM           DD 
         YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 08_Version 4.1_02212014 
 
 
Page 1 of 1 
 
 
 
 
 
Form 08: Antidepressant Treatment History Form (ATHF) 
1  
Who or what were the sources providing the information for this form? (Circle all that apply) 
a.  Patient Interview    b. Patient Record    c. Pharmacy Records    d. Family Member Interview 
e. Prescribing Physician    f. Therapist        
2  
Were antidepressant medications or other treatments for depression (excluding psycho- 
therapy) taken during past and/or current episodes?    
 
___  No  ___Yes   If yes, please list the medications in the table below.  If no, form is complete. 
 
Antidepressant Medications Taken During Past and/or Current Episode. Please record the following information for each antidepressant medication taken. 
A.  
B.  
C.  
D.  
E.  
F.  
G.  
H.  
I.  
J. 
K.  
Medication Name Generic name 
(Please Print)  
Blood 
Level(ng/mL) 
Dose(mg/day) 
Start Date 
(mm/dd/yyyy) 
Stop Date 
(mm/dd/yyyy) 
Total Number of 
Weeks in Treatment  
Reason Stopped  
Outcome  
Overall 
Confidence 
Rating  
 
Antidepressant 
Resistance Rating 
Adequate Trials 
3-1 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-2 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-3 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-4 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-5 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-6 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-7 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-8 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-9 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
3-10 
 
 
_ _ _ 
_ _/_ _/_ _ _ _ 
_ _/_ _/_ _ _ _ 
 
 
__ 
 
 
 
 
Outcome Abbreviations (H)   
Overall Confidence Rating (I) 
Antidepressant Resistance Rating (J) 
 
Adequate Trial(K) 
 
(-1) Worse 
(1) No Confidence  
See rating scales (in “ATHF Instruction 
 
(0) I score OR J score 0-2 
 
(0) No Change 
(2) Low Confidence 
Guide and Rating Scales”) for scoring. 
 
(1) I score AND J score both ≥ 3 AND H ≠ 3 
 
(1) Marginally Improved 
(3) Moderate Confidence 
 
 
 
 
 
Total scores in K must be ≥ 2 for study eligibility 
 
(2) Markedly Improved                         (4) Strong Confidence 
 
(3) Remitted (ineligible) 
(5) High Confidence 
 
 
 
 
 
 
 
 
(9) No Information 
 
 
 
 
 
 
 
 
COMPLETE AT SCREENING ONLY

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
MM          DD                  YYYY 
©Copyright 1979 by Harvey A Skinner Ph. D. 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 09_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 1 of 1 
Form 09 – LIFETIME DRINKING HISTORY 
 
 
AGE RANGE 
YOUNGER TO 
OLDER 
FREQUENCY 
DAYS/MONTH 
QUANTITY
DRINKS/DAY 
TYPE
% 
STLYE
(CIRCLE ONE) 
LIFE EVENT OR CHANGES
POSITIVE (+) OR NEGATIVE (-) 
CONTEXT
% 
TIME
% 
1 
FROM  _____ 
 
TO        _____ 
 
____________ 
AVERAGE ___ 
 
MAXIMUM ___ 
BEER     _____ 
 
LIQUOR _____ 
 
WINE     _____ 
 
1 Occasional 
2 Weekend 
3 Binge 
4 Frequent 
__ 1 Family              __ 7 Financial 
__ 2 Work                __ 8 Peer Group 
__ 3 School             __ 9 Drug Use 
__ 4 Medical           __ 10 Treatment 
__ 5 Residence       __ 11 Death 
__ 6 Legal – Jail      __ 12 Emotional 
 
Alone ___ 
 
With  
Others ___ 
Morning ___ 
 
Afternoon ___ 
 
Evening ___ 
 
2 
FROM  _____ 
 
TO        _____ 
 
____________ 
AVERAGE ___ 
 
MAXIMUM ___ 
BEER     _____ 
 
LIQUOR _____ 
 
WINE     _____ 
 
1 Occasional 
2 Weekend 
3 Binge 
4 Frequent 
__ 1 Family              __ 7 Financial 
__ 2 Work                __ 8 Peer Group 
__ 3 School             __ 9 Drug Use 
__ 4 Medical           __ 10 Treatment 
__ 5 Residence       __ 11 Death 
__ 6 Legal – Jail      __ 12 Emotional 
 
Alone ___ 
 
With  
Others ___ 
Morning ___ 
 
Afternoon ___ 
 
Evening ___ 
 
3 
FROM  _____ 
 
TO        _____ 
 
____________ 
AVERAGE ___ 
 
MAXIMUM ___ 
BEER     _____ 
 
LIQUOR _____ 
 
WINE     _____ 
 
1 Occasional 
2 Weekend 
3 Binge 
4 Frequent 
__ 1 Family              __ 7 Financial 
__ 2 Work                __ 8 Peer Group 
__ 3 School             __ 9 Drug Use 
__ 4 Medical           __ 10 Treatment 
__ 5 Residence       __ 11 Death 
__ 6 Legal – Jail      __ 12 Emotional 
 
Alone ___ 
 
With  
Others ___ 
Morning ___ 
 
Afternoon ___ 
 
Evening ___ 
 
4 
FROM  _____ 
 
TO        _____ 
 
 
____________ 
AVERAGE ___ 
 
MAXIMUM ___ 
BEER     _____ 
 
LIQUOR _____ 
 
WINE     _____ 
 
1 Occasional 
2 Weekend 
3 Binge 
4 Frequent 
__ 1 Family              __ 7 Financial 
__ 2 Work                __ 8 Peer Group 
__ 3 School             __ 9 Drug Use 
__ 4 Medical           __ 10 Treatment 
__ 5 Residence       __ 11 Death 
__ 6 Legal – Jail      __ 12 Emotional 
 
Alone ___ 
 
With  
Others ___ 
Morning ___ 
 
Afternoon ___ 
 
Evening ___ 
 
 
1 Drink (approx.) = 12 oz. beer 
Liquor: 1 mickey (12oz) = 8 Drinks 
 
1.5 oz liquor 
 
1 bottle   (25oz) = 17 Drinks 
 
5 oz wine 
 
3 oz fortified wine 
Wine:  1 bottle   (25oz) = 5 Drinks 
 
13.6 g absolute alcohol 
1 bottle fortified = 8 Drinks
COMPLETE AT BASELINE ONLY 

 
 
 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
 
MM         DD                  YYYY 
CRF 10A - Retain as Source Document. Do Not Discard.  
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 10A_Version 4.1_02212014 
 
Page 1 of 2 
Form 10A – CAPS SUMMARY SHEET BASELINE 
 
 
 
 
 
 
 
 
B. Re-experiencing Symptoms (past month) 
PAST MONTH 
LIFETIME 
 
Freq 
Int 
F+ I 
Freq 
Int 
F+ I 
1. intrusive recollections 
 
 
 
 
 
 
2. distressing dreams 
 
 
 
 
 
 
3. acting or feeling as if event were recurring 
 
 
 
 
 
 
4. psychological distress at exposure to cues 
 
 
 
 
 
 
5. physiological reactivity on exposure to cues 
 
 
 
 
 
 
B Subtotals
 
 
 
 
 
 
 
 
C. Avoidance and Numbing Symptoms 
PAST MONTH 
LIFETIME 
 
Freq 
Int 
F+ I 
Freq 
Int 
F+ I 
6.  avoidance of thoughts or feelings 
 
 
 
 
 
 
7.  avoidance of activities, places, or people 
 
 
 
 
 
 
8.  inability to recall important aspects of trauma 
 
 
 
 
 
 
9.  diminished interest in activities 
 
 
 
 
 
 
10.  detachment or estrangement 
 
 
 
 
 
 
11.  restricted range of affect 
 
 
 
 
 
 
12.  sense of foreshortened future 
 
 
 
 
 
 
C Subtotals
 
 
 
 
 
 
 
A. History of traumatic event ...................................................................... No 
Yes 
 
COMPLETE AT BASELINE ONLY 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CRF 10A - Retain as Source Document. Do Not Discard.  
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 10A_Version 4.1_02212014 
 
Page 2 of 2 
 
D. Hyperarousal Symptoms 
PAST MONTH 
LIFETIME 
 
Freq 
Int 
F+ I 
Freq 
Int 
F+ I 
13.  difficulty falling or staying asleep 
 
 
 
 
 
 
14.  irritability or outbursts of anger 
 
 
 
 
 
 
15.  difficulty concentrating 
 
 
 
 
 
 
16.  hyperviligance 
 
 
 
 
 
 
17.  exaggerated startle response 
 
 
 
 
 
 
D Subtotals
 
 
 
 
 
 
 
 
Total frequency, Intensity, and Severity (F+I) 
PAST MONTH 
LIFETIME 
Freq 
Int 
F+ I 
Freq 
Int 
F+ I 
Sum of subtotals (B+C+D)
 
 
 
 
 
 
 
 
E. Duration of disturbance 
CURRENT 
LIFETIME 
18.  with delayed onset (≥ 6 months delay) 
NO 
YES 
NO 
YES 
 
 
 
 
 
 
F. Significant distress or impairment in functioning 
PAST MONTH 
LIFETIME 
20.  subjective distress 
 
 
21.  impairment in social functioning 
 
 
22.  impairment in occupational functioning 
 
 
 
 
Global ratings 
PAST MONTH 
LIFETIME 
23.  global validity 
 
 
24.  global severity 
 
 
25.  global improvement 
 
 
 
 
SC Signature _______________________________   Date _____________________ 
 
CURRENT 
LIFETIME 
19.  duration of disturbance at least one month 
NO 
YES 
NO 
YES 
 
CURRENT 
LIFETIME 
19.  acute (< 3 months) or chronic (≥ 3 months) 
Acute 
Chronic 
Acute 
Chronic

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
 
MM         DD                  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 10B_Version 4.1_02212014 
 
 
Page 1 of 2 
Form 10B – CAPS SUMMARY SHEET  
 
 
 
 
 
 
 
B. Re-experiencing Symptoms (past month) 
PAST MONTH 
 
Freq 
Int 
F+ I 
1. intrusive recollections 
 
 
 
2. distressing dreams 
 
 
 
3. acting or feeling as if event were recurring 
 
 
 
4. psychological distress at exposure to cues 
 
 
 
5. physiological reactivity on exposure to cues 
 
 
 
B Subtotals
 
 
 
 
 
C. Avoidance and Numbing Symptoms 
PAST MONTH 
 
Freq 
Int 
F+ I 
6.  avoidance of thoughts or feelings 
 
 
 
7.  avoidance of activities, places, or people 
 
 
 
8.  inability to recall important aspects of trauma 
 
 
 
9.  diminished interest in activities 
 
 
 
10.  detachment or estrangement 
 
 
 
11.  restricted range of affect 
 
 
 
12.  sense of foreshortened future 
 
 
 
C Subtotals
 
 
 
 
A. History of traumatic event ...................................................................... NO 
Yes 
 
Circle Visit Below: 
END OF ACTIVE TREATMENT  
FINAL FOLLOW UP VISIT 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 10B_Version 4.1_02212014 
 
 
Page 2 of 2 
 
D. Hyperarousal Symptoms 
PAST MONTH 
 
Freq 
Int 
F+ I 
13.  difficulty falling or staying asleep 
 
 
 
14.  irritability or outbursts of anger 
 
 
 
15.  difficulty concentrating 
 
 
 
16.  hyperviligance 
 
 
 
17.  exaggerated startle response 
 
 
 
D Subtotals
 
 
 
 
 
Total frequency, Intensity, and Severity (F+I) 
PAST MONTH 
Freq 
Int 
F+ I 
Sum of subtotals (B+C+D)
 
 
 
 
 
E. Duration of disturbance 
CURRENT 
18.  with delayed onset (≥ 6 months delay) 
NO 
YES 
 
 
 
 
 
 
F. Significant distress or impairment in functioning 
PAST MONTH 
20.  subjective distress 
 
21.  impairment in social functioning 
 
22.  impairment in occupational functioning 
 
 
 
Global ratings 
PAST MONTH 
23.  global validity 
 
24.  global severity 
 
25.  global improvement 
 
 
 
SC Signature _______________________________   Date ______________________ 
 
CURRENT 
19.  duration of disturbance at least one month 
NO 
YES 
 
CURRENT 
19.  acute (< 3 months) or chronic (≥ 3 months) 
Acute 
Chronic 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
Site __ __      Participant # __ __ __ __ __    Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 11_Version 4.1_02212014 
 
 
Page 1 of 5  
 
Form 11 – TRAUMA HISTORY QUESTIONNAIRE 
 
The following is a series of questions about serious or traumatic life events.  
These types of events actually occur with some regularity, although we would like to 
believe they are rare, and they affect how people feel about, react to, and/or think about 
things subsequently.  The questionnaire is divided into questions covering crime 
experiences, general disaster and trauma questions, and questions about physical and 
sexual experiences. 
 
For each event, please indicate (circle) whether it happened, and if it did, the 
number of times and your approximate age when it happened (give your best guess if 
you are not sure).  Also note the nature of your relationship to the person involved, and 
the specific nature of the event, if appropriate. 
 
Crime-Related Events    
 
 
If Yes 
 
  
 
 
 # of         Approx. 
 
 
 
times       Age 
 1. 
Has anyone ever tried to take 
 
something directly from you 
 
by using force or the threat 
 
of force, such as a stick-up 
 
or mugging? 
No 
Yes   
_______ _______ 
 
 
2. 
Has anyone ever attempted to 
 
rob you or actually robbed you  
 
(i.e. stolen your personal  
 
belongings)? 
No 
Yes 
_______ _______ 
 
 
3. 
Has anyone ever attempted to or 
 
succeeded in breaking into your 
 
home when you weren’t there? 
No 
Yes 
_______ _______ 
 
 
4. 
Has anyone ever tried to or  
 
succeeded in breaking into your 
 
home while you were there?       
No 
Yes  
_______ ______ 
COMPLETE AT BASELINE ONLY 

Site __ __      Participant # __ __ __ __ __    Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 11_Version 4.1_02212014 
 
 
Page 2 of 5  
 
General Disaster and Trauma 
 
 
If Yes 
 
 
 
  
 # of 
   Approx. 
  
 
 
 
times       Age 
 
5. 
Have you ever had a serious 
 
accident at work, in a car or 
 
somewhere else? 
No 
Yes 
_______ ______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
6. 
Have you ever experienced a  
 
natural disaster such as a 
 
tornado, hurricane, flood, major 
 
earthquake, etc., where you felt 
 
you or your loved ones were in 
 
danger of death or injury?  
No 
Yes 
_______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
7. 
Have you ever experienced a  
 
"man-made" disaster such as a  
 
train crash, building collapse,  
 
bank robbery, fire, etc., where 
  
you felt you or your loved ones 
 
were in danger of death or injury? 
No 
Yes 
_______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
8. 
Have you ever been exposed to  
 
dangerous chemicals or  radioac- 
 
tivity that might threaten your 
 
health?  
No 
Yes 
_______ _______ 
 
 
9. 
Have you ever been in any other 
 
situation in which you were 
 
seriously injured?                
No 
Yes 
_______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
  

Site __ __      Participant # __ __ __ __ __    Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 11_Version 4.1_02212014 
 
 
Page 3 of 5  
 
 
                            
 
 
 If Yes 
 
 
 
  
 # of 
   Approx. 
  
 
 
 
times       Age 
10. 
Have you ever been in any other 
 
situation in which you feared you  
 
might be killed or seriously  
 
injured? 
No 
Yes 
_______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
11. 
Have you ever seen someone  
 
seriously injured or killed?       
No 
Yes 
_______ _______ 
 
 
 
If yes, please specify who:  _____________________________________ 
 
 
12.   Have you ever seen dead bodies 
 
(other than at a funeral) or had  
 
to handle dead bodies for any 
 
reason?   
No 
Yes 
_______ ______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
13. 
Have you ever had a close friend 
 
or family member murdered, or  
 
killed by a drunk driver? 
No 
Yes 
______ _______ 
 
 
 
If yes, please specify relationship  
 
 
(e.g. mother, grandson, etc.): ___________________________________ 
 
 
14. 
Have you ever had a spouse,  
 
romantic partner, or child die? 
No 
Yes 
______ _______ 
 
 
 
If yes, please specify relationship:  _______________________________ 
 
 
15. 
Have you ever had a serious 
      
or life-threatening illness?      
No 
Yes 
______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
  

Site __ __      Participant # __ __ __ __ __    Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 11_Version 4.1_02212014 
 
 
Page 4 of 5  
 
 
 
 
 
If Yes 
 
 
 
  
# of 
Approx. 
  
 
 
 
times Age 
16. 
Have you ever received news of a  
 
serious injury, life-threatening 
 
illness or unexpected death 
 
of someone close to you?  
No 
Yes 
______ _______ 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
17. 
Have you ever had to engage in  
 
combat while in military service 
 
in an official or unofficial war 
No 
 Yes 
______ _______ 
 
zone? 
 
 
 
If yes, please specify:  _________________________________________ 
 
 
Physical and Sexual Experiences 
 
 
 
 
If Yes  
 
 
 
 
Was it 
Approx. 
Approx. 
 
 
 
 
repeated? how often 
what age(s) 
18.  
Has anyone ever made you have 
 
intercourse, oral or anal sex  
 
against your will? 
No 
Yes 
______ 
_______ 
______ 
 
 
 
If yes, please indicate nature of relationship with person (e.g. stranger,  
 
 
friend, relative, parent, sibling):__________________________________ 
 
 
19. 
Has anyone ever touched  
 
private parts of your body, 
 
or made you touch theirs,  
 
under force or threat? 
No 
Yes 
______ 
_______ 
______ 
 
 
 
If yes, please indicate nature of relationship with person (e.g. stranger,  
 
 
friend, relative, parent, sibling):__________________________________ 
  
 
 
 
 
 
 
 
 
 
 
 

Site __ __      Participant # __ __ __ __ __    Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 11_Version 4.1_02212014 
 
 
Page 5 of 5  
 
 
 
 
If Yes  
 
 
 
 
Was it 
Approx. 
Approx. 
 
 
 
 
repeated? how often 
what age(s) 
20. 
Other than incidents mentioned  
 
in Questions 18 and 19, have  
 
there been any other situations  
 
in which another person tried  
 
to force you to have unwanted  
 
sexual contact? 
No 
Yes 
______ 
_______ 
______ 
 
 
 
 
 
 
21. 
Has anyone, including family 
 
members or friends, ever  
 
attacked you with a gun,  
 
knife or some other weapon?    
No 
Yes 
______ 
_______ 
______ 
 
 
22. 
Has anyone, including family 
 
members or friends, ever  
 
attacked you without a weapon  
 
and seriously injured you?    
No 
Yes 
______ 
_______ 
______ 
 
 
23. 
Has anyone in your family  
 
ever beaten, "spanked" or  
 
pushed you hard enough to  
 
cause injury? 
No 
Yes 
______ 
_______ 
______ 
 
 
 
Other Events 
 
24. 
Have you experienced any  
 
other extraordinarily  
 
stressful situation or  
 
event that is not covered  
 
above? 
No 
Yes 
______ 
_______ 
______ 
 
 
 
If yes, please specify: _________________________________________ 
 
 
 
 
 
SC Signature ________________________________   Date _____________________

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
 DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
Page 1 of 8 
 
Form 12 – LIFE STRESSOR CHECKLIST REVISED 
 
 
 
 
 
 
1. 
Have you ever been in a serious disaster (for example, an earthquake, hurricane, large 
fire, explosion)? 
Yes 
No 
 
a.  How old were you when this happened?      __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
 
 
 
2. 
Have you ever seen a serious accident (for example, a bad car wreck or an on-the-job 
accident)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __  
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
 
 
 
3. 
Have you ever had a very serious accident or accident-related injury (for example, a bad 
car wreck or an on-the-job accident)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
COMPLETE AT BASELINE ONLY 
READ THIS FIRST: Now we are going to ask you some questions about events in your life that are frightening, 
upsetting, or stressful to most people.  Please think back over your whole life when you answer these questions.  
Some of these questions may be about upsetting events you don’t usually talk about.  Your answers are 
important, but you do not have to answer any questions that you do not want to.  Thank you. 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 2 of 8 
 
 
 
 
 
 
 
 
 
4. 
Was a close family member ever sent to jail? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
5. 
Have you ever been sent to jail? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
6. 
Were you ever put in foster care or put up for adoption? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
7. 
Did your parents ever separate or divorce while you were living with them? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 3 of 8 
 
 
 
 
 
 
8. 
Have you ever been separated or divorced? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
9. 
Have you ever had serious money problems (for example, not enough money for food or 
place to live)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed or 
seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1 
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
10. 
Have you ever had a very serious physical or mental illness (for example, cancer, heart 
attack, serious operation, felt like killing yourself, hospitalized because of nerve 
problems)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
11. 
Have you ever been emotionally abused or neglected (for example, being frequently 
shamed, embarrassed, ignored, or repeatedly told that you were “no good”)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 4 of 8 
 
 
 
 
 
 
12. 
Have you ever been physically neglected (for example, not fed, not properly clothed, or 
left to take care of yourself when you were too young or ill)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
13. 
WOMEN ONLY: Have you ever had an abortion or miscarriage (lost your baby)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
14. 
Have you ever been separated from your child against your will (for example, the loss of 
custody or visitation or kidnapping)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
15. 
Has a baby or child of yours ever had a severe physical or mental handicap (for 
example, mentally retarded, birth defects, can’t hear, see, walk)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 5 of 8 
16. 
Have you ever been responsible for taking care of someone close to you (not your child) 
who had a severe physical or mental handicap (for example, cancer, stroke, AIDS, nerve 
problems, can’t hear, see, walk)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
17. 
Has someone close to you died suddenly or unexpectedly (for example, sudden heart 
attack, murder or suicide)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
18. 
Has someone close to you died (do NOT include those who died suddenly or 
unexpectedly)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
19. 
When you were young (before age 16), did you ever see violence between family 
members (for example, hitting, kicking, slapping, punching)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
 
 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
 DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
Page 6 of 8 
20. 
Have you ever seen a robbery, mugging, or attack taking place? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
21. 
Have you ever been robbed, mugged, or physically attacked (not sexually) by someone 
you did not know? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
 
 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
22. 
Before age 16, were you ever abused or physically attacked (not sexually) by someone 
you knew (for example, a parent, boyfriend, or husband, hit, slapped, choked, burned, or 
beat you up)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
23. 
After age 16, were you ever abused or physically attacked (not sexually) by someone 
you knew (for example, a parent, boyfriend, or husband, hit, slapped, choked, burned, or 
beat you up)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 7 of 8 
 
 
 
 
 
 
24. 
Have you ever been bothered or harassed by sexual remarks, jokes, or demands for 
sexual favors by someone at work or school (for example, a coworker, a boss, a 
customer, another student, a teacher)? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
25. 
Before age 16, were you ever touched or made to touch someone else in a sexual way 
because he/she forced you in some way or threatened to harm you if you didn’t? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
26. 
After age 16, were you ever touched or made to touch someone else in a sexual way 
because he/she forced you in some way or threatened to harm you if you didn’t? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
27. 
Before age 16, did you ever have sex (oral, anal, genital) when you didn’t want to 
because someone forced you in some way or threatened to hurt you if you didn’t? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 12_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
Page 8 of 8 
 
 
 
 
 
 
28. 
After age 16, did you ever have sex (oral, anal, genital) when you didn’t want to because 
someone forced you in some way or threatened to hurt you if you didn’t? 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
29. 
Are there any events we did not include that you would like to mention? 
What was the event? _____________________________________________________ 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
30. 
Have any of the events mentioned above ever happened to someone close to you so 
that even though you didn’t see it yourself, you were seriously upset by it? 
What was the event? _____________________________________________________ 
Yes 
No 
 
a.  How old were you when this happened?     __ __ 
b. When it ended?     __ __ 
 
c.  At the time of the event did you believe that you or someone else could be killed 
or seriously harmed? 
Yes  
No 
 
d.  At the time of the event did you experience feelings of intense helplessness, fear, or 
horror?  
Yes  
No 
 
e.  How much has this affected your life in the past 
year?  
1  
Not at all 
2 
3 
Some 
4 
5 
Extremely 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature ________________________________   Date _______________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
 
 
 
 
 
 
Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                              
 
                 MM          DD                YYYY 
Weighted error scores greater than 10 are consistent with dementia, according to Katzman et al. (1983). 
 
Source: Katzman, R., Brown, T., Fuld, P., Peck, A., Schecter, R., & Schimmel, H.  (1983).  Validation of a short orientation-memory-
concentration test of cognitive impairment.  American Journal of Psychiatry, 140, 734-739. 
 
Copyright is held by American Psychiatric Association.  Permission from test author R. Katzman to VA for VA use. 
 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 13_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 1 of 1 
 
 
Form 13 – The Six-Item Blessed Orientation-Memory-Concentration  
(BOMC) Test 
 
 
 
Maximum 
Items   
 
 
Error   
Score   
Weight 
1  
What year is it now?  
 
1  
 
____x  
4 = ____ 
 
2  
What month is it now?  
 
1  
 
____x  
3 = ____ 
 
 
Memory phrase 
 Repeat this phrase after me: 
 
 
 
John Brown, 42 Market Street, Chicago 
 
3  
About what time is it?  
 
1  
 
____x  
3 = ____ 
 
(within 1 hour) 
 
4  
Count backwards 20 to 1   
2  
 
____x   
2 = ____ 
 
5  
Say the months in reverse order  2 
 
____x  
2 = ____ 
 
6  
Repeat the memory phrase  
5  
 
____x  
2 = ____ 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature __________________________________   Date _____________________
COMPLETE AT SCREENING ONLY 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __       Participant # __ __ __ __ __     Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
                                                      
 
           MM           DD              YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 14_Version 4.1_02212014 
 
 
Page 1 of 1 
Form 14 – BIRTH CONTROL/PREGNANCY ASSESSMENT 
(Women Only) 
 
 
 
1. What method of birth control is participant currently using?  .................................. ____  ____ 
01 = Complete abstinence (not having sexual intercourse with anyone) 
02 = Oral contraceptive (birth control pills) 
 
03 = Norplant 
04 = Depo-Provera© 
05 = Condom with spermicide 
06 = Cervical cap with spermicide  
07 = Diaphragm with spermicide  
08 = Intrauterine Device 
09 = Surgical Sterilization (tubal ligation)  
 
record month/year of procedure ......................................... ___  ___ / ___ ___ ___ ___ 
10 = Hysterectomy, record month/year of procedure .................. ___  ___ / ___ ___ ___ ___ 
11 = Post-menopausal, record date of last menstrual period ...... ___  ___ / ___ ___ ___ ___ 
12 = Other method of birth control, specify ________________________________________ 
 
2. Was a pregnancy test performed? (0=No, 1=Yes) ....................................................... ______ 
 
If Yes: 
 
a.   Result of pregnancy test (1 = Positive, 2 = Negative,) .......................................  ____ 
 
b.  Date specimen collected  ......  Mo ___ ___  Day ___ ___  Yr ___ ___ ___ ___
COMPLETE WITHIN 7 DAYS PRIOR TO RANDOMIZATION AND 
EVERY 4 WEEKS THEREAFTER, THROUGHOUT THE STUDY 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                      
 
     
 
               MM       DD 
      YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 15_Version 4.1_02212014 
 
 
 
Page 1 of 2 
Form 15 - Prior and Concomitant Medications Log 
 
 
 
 Was medication taken during the time period described above? 
No 
Yes 
 
Medication 
Name 
Purpose/ 
Indication 
On-
Going 
Start Date 
Dose 
Units 
(other)
Frequency 
(other) 
Dose 
Form 
(other) 
Route 
(other) 
Total  
Daily Dose 
Stop Date 
AE 
Reference # 
1 ___________
___________ 
_____________
_____________ 
No 
Yes 
__ __ /__ __ 
/__ __ __ __ 
__ __ __ __ 
. __ __ 
__  
_____
_____ 
__  
_________ 
__  
______
______ 
__  
_____
_____ 
__ __ __ __ 
. __ __ 
__ __ /__ __  
/__ __ __ __ 
__________
__________ 
2 ___________
___________ 
_____________
_____________ 
No 
Yes 
__ __ /__ __ 
/__ __ __ __ 
__ __ __ __ 
. __ __ 
__  
_____
_____ 
__  
_________ 
__  
______
______ 
__  
_____
_____ 
__ __ __ __ 
. __ __ 
__ __ /__ __  
/__ __ __ __ 
__________
__________ 
3 ___________
___________ 
_____________
_____________ 
No 
Yes 
__ __ /__ __ 
/__ __ __ __ 
__ __ __ __ 
. __ __ 
__  
_____
_____ 
__  
_________ 
__  
______
______ 
__  
_____
_____ 
__ __ __ __ 
. __ __ 
__ __ /__ __  
/__ __ __ __ 
__________
__________ 
4 ___________
___________ 
_____________
_____________ 
No 
Yes 
__ __ /__ __ 
/__ __ __ __ 
__ __ __ __ 
. __ __ 
__  
_____
_____ 
__  
_________ 
__  
______
______ 
__  
_____
_____ 
__ __ __ __ 
. __ __ 
__ __ /__ __  
/__ __ __ __ 
__________
__________ 
 
 
 
Page # __ __
Begin this log on the day the subject signs the informed consent. Record all medications taken 
by the subject 30 days prior to signing the informed consent through week 24 of Follow-up. 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 15_Version 4.1_02212014 
 
 
 
 
Page 2 of 2 
 
 
Concomitant Medications Codes 
 
 
Units  
Frequency 
Dose Form 
Route  
01 = Capsule/Tablet  
1 = Once a day 
1 = Tablet 
1 = Oral  
02 = Drop  
2 = Twice daily 
2 = Capsule 
2 = Topical 
03 = International Units 
3 = Three times a day 
3 = Ointment 
3 = Subcutaneous 
04 = Micrograms 
4 = Four times a day 
4 = Aerosol 
4 = Transdermal 
05 = Milliequivalents 
5 = Every other day 
5 = Spray 
5 = Intraocular 
06 = Milligram 
6 = Every month 
6 = Suspension 
6 = Intramuscular 
07 = Milliliter 
7 = PR (as needed) 
7 = Patch 
7 = Inhalation 
08 = Puff 
99 = Other 
8 = Gas 
8 = Intralesion 
09 = Spray/Squirt 
 
9 = Gel 
9 = Intraperiteoneal 
10 = Units (for Insulin) 
 
10 = Cream 
10 = Nasal 
11 = Tablespoon 
 
11 = Powder 
11 = Vaginal 
12 = Teaspoon 
 
99 = Other 
12 = Rectal 
99 = Other 
 
 
13 = Intravenous 
 
 
 
14 = Sublingual 
 
 
 
99 = Other 

 
  VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __       Participant # __ __ __ __ __        Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
 
 
           
MM           DD 
  YYYY 
 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 16_Version 4.1_02212014 
 
 
 
Page 1 of 1 
FORM 16 –Study Clinic Visit Form 
 
 
 
 
 
 
1. 
Did the participant come in for this assessment session?  (Circle One)  .............. NO    YES 
 
a. If ‘No’, please indicate if the interview was conducted by: 
 
 (Circle One) ..................................................................... Telephone   Mail    Both    Neither 
2. 
Did the participant drink alcohol since the last assessment session? (Circle One) NO    YES 
a. If ‘Yes’, please indicate how many drinks .................................................... ________ 
 
3. 
Did the participant use a non-alcoholic substance in a manner that is restricted by the 
protocol since the last assessment session? (Circle One) .................................... NO    YES 
ANSWER QUESTION 4 ONLY AFTER ACUTE TREATMENT SESSIONS 20, 25, and 30. 
4. 
Did participant receive a score on the HRSD of ≤10? (Circle One) ...................... NO    YES 
If ‘Yes’, 
 a. Is participant going to Taper? (Circle One)  .............................................. NO    YES 
  
i. If ‘No’, Why? __________________________________________________ 
If ‘No’, 
b. If HRSD of >10 is the participant going to continue to additional 5 sessions? 
 (Circle One)  .................................................................................................. NO    YES 
 
 i. If ‘No’, Why? __________________________________________________ 
 
 NOTE: If ‘No’, do not taper and participant will enter Follow-up Phase. 
 
ANSWER QUESTIONS 5-7 IN FOLLOW UP PHASE, STARTING WITH WEEK 4. 
5. 
Did participant experience an Adverse Event? (Circle One)  ................................ NO    YES 
 
       If ‘Yes’, fill out Adverse Event form pack 
6. 
Did participant experience a Serious Adverse Event? (Circle One)  ..................... NO    YES 
        If ‘Yes’, fill out Adverse Event form pack 
7. 
Did participants medications change? (Circle One)  ............................................. NO    YES 
 
       If ‘Yes’, fill Medication form pack
Circle Visit Below:  
 
Acute Treatment Phase Sessions: 
5 
10 
15 
20 
25 
30 
 
Taper Week:  
 
 
 
1 
2 
3 
 
 
Follow-up Phase Weeks:  
 
4 
8 
12 
16 
20 
24 

 
 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
MM          DD 
  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 17_Version 4.1_02212014 
Page 1 of 1
Form 17 – Pure Tone Audiometry 
 
Frequency (Hz) 
Lowest Threshold (dB) 
Left Ear 
Right Ear 
1
125
___  ___  ___ 
___  ___  ___ 
3
500
___  ___  ___ 
___  ___  ___ 
5
1000
___  ___  ___ 
___  ___  ___ 
6
2000
___  ___  ___ 
___  ___  ___ 
7
3000
___  ___  ___ 
___  ___  ___ 
8
4000
___  ___  ___ 
___  ___  ___ 
9
6000
___  ___  ___ 
___  ___  ___ 
10
8000
___  ___  ___ 
___  ___  ___ 
Circle Visit Below: 
Screening 
End of Acute Treatment 
Final Follow-up Visit 

  
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
MM         DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 18_Version 4.1_02212014  
 
 
 
Page 1 of 3 
 
 Form 18 – rTMS TREATMENT LOG 
 
 
 
Randomization Treatment Code:  ___ ___ ___ ___ ___ ____ 
Tx Session 01:  
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
Tx Session 02: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
Circle Visit Below: 
Acute Treatment Phase Sessions: 
1-5
6-10
11-15
16-20
21-25 
26-30

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __    Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                       
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 18_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 2 of 3 
 
Tx Session 03: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
 
Tx Session 04: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __    Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __ /__ __ __ __ 
                                                       
 
           MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 18_Version 4.1_02212014 
 
 
 
 
 
 
 
 
 
 
 
Page 3 of 3 
 
Tx Session 05: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
 
 
 
CODES: 
 1 = Equipment malfunction 4 = Adverse Device Event/Adverse Event 
 2 = Participant refused 
5 = Unanticipated Adverse Device Event/Serious Adverse Event 
 3 = Staff error 
6 = Other, specify _______________________________ 

                                                       
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
MM         DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 19_Version 4.1_02212014 
 
 
Page 1 of 3 
Form 19 – rTMS TAPER LOG 
 
 
 
Randomization Treatment Code:  ___ ___ ___ ___ ___ ____ 
 
WEEK 01 –  
Tx Session 01:  
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
Tx Session 02: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
Complete during Follow Up Weeks 1-3 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
MM           DD 
  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 19_Version 4.1_02212014 
 
 
 
Page 2 of 3 
Tx Session 03: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
WEEK 02 –  
Tx Session 01: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
 
 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
MM           DD 
  YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 19_Version 4.1_02212014 
 
 
 
Page 3 of 3 
 
Tx Session 02: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
WEEK 03 –  
Tx Session 01: 
1. 
Date of Treatment Session: __ __ / __ __ / __ __ __ __ 
2. 
Did participant’s medications change from previous session? No   Yes  If yes, fill out 
Medication Form pack            
3. 
Did the participant have an adverse event since the last session?  No    Yes  If yes, fill out 
Adverse Event Form pack              AE Reference # __________________ 
4. 
Did the participant have a serious adverse event since the last session?  No    Yes  If yes, fill 
out Adverse Event Form pack       AE Reference # __________________ 
5. 
How many hours of sleep did the participant get last night? ___ ___  hours 
6. 
 
Since your last treatment session have you consumed any of the following: 
a.  Alcohol: No   Yes  If yes, how many drinks __ __ (see drinking chart for conversion) 
 
b. Illegal drugs: No   Yes  If yes, what kind ___________ and how much _____  
7. 
Number of Styrofoam layers  _____  
8. 
Current Stimulation Intensity (select only one)      3      5      7  
9. 
MT Determination  ___ ___ ___ % 
10. Power output at treatment delivery  ___ ___ ___ % 
11. Was the rTMS treatment completed?     No   Yes     
12. If No, specify the primary reason using the codes (see last page for codes) _____ 
13. rTMS administrator’s initials: _____________ 
 
 
CODES: 
 1 = Equipment malfunction 
4 = Adverse Device Event/Adverse Event 
 2 = Participant refused 
5 = Unanticipated Adverse Device Event/Serious Adverse Event 
 3 = Staff error 
6 = Other, specify _______________________________ 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __       Participant # __ __ __ __ __          Alpha Code __ __ __ __           Date __ __ / __ __ / __ __ __ __ 
 
                
 
 
MM 
  DD 
 YYYY  
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 20_Version 4.1_02212014 
 
 
Page 1 of 29 
Form 20 – HRSD and MADRS 
 
 
 
Interviewer’s Initials: 
__ __ __ 
 
Start Time: 
__ __ __ __ (24 hour clock) 
MANUAL SCORING INSTRUCTIONS: Write the score of the item in the box for the 24 HRSD items.  Take the sum of these values and write it in the Total HRSD 
Score box at the end of the form. 
Introductory Questions: “I’d like to ask you some questions about the past week. Since last (DAY OF THE WEEK), how have you been feeling? Have you 
noticed any change in how you have been feeling during the past week compared to before?” 
Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
SLEEP (Early and Middle Insomnia) 
“Let’s talk about your sleep. During the past week, what were your usual hours of going to sleep and waking up? How many hours of sleep at night would be best 
for you?” If patient had a significant period of euthymia in past 5 years: “How many hours of sleep did you get when you were not depressed and feeling 
well?” 
“Have you had any trouble this week falling asleep 
at the beginning of the night?” 
After you have gone to bed, how long has it been 
taking you to fall asleep?  
How many nights this week have you had trouble 
falling asleep? 
H4. INSOMNIA – EARLY  
 (0)  Less than or equal to 1/2 hr to fall asleep 
(always add a point for use of a hypnotic at 
bedtime) 
 (1)  Greater than 1/2 hr at least 2 days and less 
than 5 nights in the past week  
 (2)  Greater than 1/2 hr 5 or more nights in the 
past week 
 
 
 
Circle Visit Below: 
Screening  
Acute Treatment Phase Sessions:  
5 
10 
15 
20 
25 
30 
Follow-up Phase Weeks:
4
8
12 
16
20
24

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __ / __ __ / __ __ __ __ 
 
 
 
 
MM 
 DD 
YYYY  
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 20_Version 4.1_02212014 
 
 
 
Page 2 of 29 
 
 
 
Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
Middle insomnia typically covers the period between 
12 and 3 AM, depending on sleep onset.  Rule of 
thumb is to add 2 hr to sleep onset time and take a 
3 hr interval.  (Add a point if a hypnotic is taken on 
awakening during the night).  
“During the past week, have there been some nights 
where your sleep was restless or disturbed?”  
How many nights have you had that trouble?  
During the past week, have you been waking up in 
the middle of the night?  
IF YES: Did you get out of bed?  
Was it to go to the bathroom?  
How long did it take you to fall back asleep?  
How many nights this past week did you wake up 
and get out of bed (other than to go to the 
bathroom)? 
H5. INSOMNIA – MIDDLE  
 (0)  Once asleep, stays asleep and is not restless 
 (1)  patient is restless during the night or 
awakens without getting out of bed (2 or more 
nights per week)  
 (2)  Patient is awake for any noticeable period of 
time (5 or more nights).  Patient reports getting 
out of bed for any reason other than to void (2 or 
more nights) 
 
SLEEP (Late Insomnia, Hypersomnia, and Reduced Sleep) 
Many times information on this item is elicited by 
questions about middle insomnia.  As with 
hypersomnia, ratings of late insomnia are in 
comparisons to a standard of the total hours of 
sleep the patient should have.  If this is unclear 
from the initial questioning in the insomnia section 
(“How many hours of sleep at night would be best 
for you?”), assume 7-8 hrs as normal sleep 
duration. 
 “This past week, what time have you been waking 
up in the morning and staying up?”  
 Are you waking up at the time you want to or are 
you waking up earlier than you want?  
IF WAKING UP EARLY: How many mornings this 
week have you awakened early?   
When you got up early, could you fall back to sleep 
again or were you awake for the day?  
This past week, did you feel you got enough sleep 
or were you tired when you woke up? 
H6. INSOMNIA – LATE  
 (0)  Sleeps through to morning (7-8 hr since 
sleep onset or length of preferred sleep) 
 (1)  Awakens towards morning (4-6 AM), but falls 
back to sleep (2 or more nights) 
 (2)  Awakens  towards morning (4-6 AM) and 
stays awake (2 or more nights) 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
Like the insomnia items, rating of hypersomnia are 
in comparison to some standard of the total number 
of hours of sleep the patient should have.  If this is 
unclear or doubtful from the initial questioning in the 
insomnia section (“How many hours of sleep at 
night would be best for you?”), assume 7-8 hrs as 
normal sleep duration.  
“During the past week, how many total hours of 
sleep did you get each day?”  
During the past week, how many hours each day 
did you spend sleeping and napping? 
H26. Hypersomnia  
 (0)  No increase in total sleep length 
 (1)  At least 1 hour increase in sleep length at 
least 2 days per week 
 (2)  At least 2 hour increase in sleep length at 
least 5 days per week 
 (3)  At least 4 hour increase in sleep length at 
least 5 days per week 
 
 
After the 4 inquiries about sleep, score the 
associated MADRS item.  Additional questions are 
usually not necessary. 
 
M4. REDUCED SLEEP 
 (0) Regardless of severity, sleep disturbance 
manifested at most one night per week  
 (1) 
 (2)  Early, middle or late insomnia less than 1 hr 
per night and present at least 2 or more nights 
per week or light or fitful sleep 2 or more nights 
per week  
 (3) 
 (4)  Awake for at least 2 hours total for 2 or more 
nights per week  
 (5) 
 (6)  Unable to sleep so that only 2-3 hours of 
sleep obtained at least 5 nights per week 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
WORK AND ACTIVITIES (Interest and Lassitude) 
“This past week have you felt interested in your 
work, hobbies, and other activities? Did you have to 
push yourself to get things done or did other people 
have to encourage you to get things done?”  
LASSITUDE: “Have you had any difficulty in starting 
activities? Have you been sluggish in starting 
activities? Do you have to force yourself to complete 
routine tasks?”  
(Skip for inpatients)  “Have you completed your 
household responsibilities during the past week?” IF 
NO:“How so? Or Why?”  
(Skip for inpatients)  “Are you working or going to 
school?  This past week, did you miss any time from 
work (or school)?”  IF YES: “How so? Or Why?”  
IF LACK OF INTEREST ACKNOWLEDGED: Was 
there any activity this past week that you felt 
interested in completing or did you lack interest in 
everything?  
Is there anything that you stopped doing altogether 
this past week? 
 Do you think that you spent less time than you 
should on your work, household chores, or 
recreational activities?   
IF YES, about how much less time did you spend on 
these activities each day this past week?   
H7. WORK AND ACTIVITIES  
 (0) No lack of interest or diminished activity.  
Patient feels interested (motivated), spends 
more than 3 hrs each day in productive activity 
(household chores, school, work, hobbies, etc.), 
and believes can return to usual (full) activities 
without fatigue or feelings of incapacity (or has 
returned without fatigue or feelings of incapacity) 
 (1) Spends more than 3 hrs per day in productive 
activity (see 0 above), but  has thoughts or 
feelings of incapacity, fatigue or weakness  
 (2)  Has diminished interest in activities or 
experiences or expresses indecision or 
listlessness.  Feels the need to push oneself to 
complete activities 
 (3)  Decreased time or productivity in activities 
and/or spends less than 3 hours per day in 
productive activity  
 (4)  Does not attend to basic activities of daily 
living (e.g., grooming, keeping room in order, 
etc.).  No longer engages in household chores 
and is not working.   "Not working" alone is 
insufficient to merit a "4".  Patient should have 
stopped virtually all productive activity and not 
attended to basic activities of daily living. 
 

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HRSD Scoring Criteria
MADRS Scoring Criteria
The focus of this item is on difficulties in starting 
activities, and not on interest in activities, per se.  
Individuals who procrastinate may have great 
difficulty starting activities, but may have 
considerable interest.  Severity on this item 
increases as greater effort and/or supervision are 
needed to carry out activities, especially routine 
matters.  
 
During the past week, did you have difficulty starting 
activities?    
Did you have to “push yourself” to get things done?  
Did you feel sluggish or rundown when doing 
routine chores? 
 
M7. LASSITUDE  
 (0) Difficulty starting any activity is infrequent (less 
than 2 days per week). does not report 
sluggishness.  
 (1) 
 (2)  Difficulty in starting some activity noted and 
more than 1 day in the week.  
 (3) 
 (4)  Carries out routine tasks, but exerts extra 
attention or effort to stay on task. Has difficulty 
initiating tasks at least 5 days per week.  
 (5) 
 (6)  Does not initiate any activity and requires 
assistance and prodding to complete most tasks. 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
IMPAIRED CONCENTRATION 
Rate the extent of the impairment in concentration.  
There are at least 3 types of impairment.  The 
patient may not be able to maintain a focus, losing 
the drift of conversations, etc.  This reflects impaired 
vigilance and is commonly seen in agitated 
depression.  Alternatively, the patient may be so 
preoccupied that they cannot shift sets and focus on 
problems at hand (preoccupation leading to 
inattention).  This is commonly seen in 
hypochondriacal or delusional patients.  Third, the 
individual may be so distracted by environmental or 
internal stimuli that they cannot maintain a set (a 
form of imparted vigilance).  This is commonly seen 
in patients with persistent cognitive impairment, e.g., 
dementia.  Regardless of type, rate this item by 
weighing both patient self-report and objective 
evidence during the interview (or the observations of 
others).  Concentration difficulties may be minimized 
by inattentive, preoccupied individuals, even though 
they will lose the thread of conversations and have 
other demonstrable deficits.  
“During the past week have you had difficulty 
concentrating? Did you have any trouble following 
conversations, following the plot of a TV program or 
movie, understanding what you read, or in carrying 
out any other activities? Did anyone comment that 
you seemed spacey, distracted, preoccupied, or 
"out-of-it"? Did you feel this way?”  
IF CONCENTRATION DIFFICULTY 
ACKNOWLEDGED:        How bad was your 
concentration problem this past week?  
Did you have to give up any activities because you 
couldn't focus your thoughts? 
 
M6. CONCENTRATION DIFFICULTIES 
 (0)  Difficulties in concentrating are infrequent 
and manifested less than 2 days per week, 
regardless of severity. 
 (1) 
 (2)  Mild difficulties in concentrating or paying 
attention 2 or more days per week.  Does not 
interfere with performance, but may involve 
paying special attention. 
 (3) 
 (4)  Difficulties in concentrating are frequent and 
interfere with function. Difficulties are manifest at 
least 5 days of the week and make reading or 
following conversations or TV programs difficult. 
 (5) 
 (6)  Pervasive problems in attention and 
concentration. Cannot maintain a focus and 
conversations become tangential (off topic). 
Individual may repeatedly ask the same 
questions. Unable to complete tasks involving a 
modicum of complexity. 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
SOMATIC SYMPTOMS (Physical symptoms, Weight)
Introductory comment: “Now I’m going to ask you some questions about your physical state.” 
Symptoms of autonomic over activity are being 
assessed.  Note the specific symptoms and their 
frequency and severity.  Except for rare exceptions 
discussed in the manual, no attribution is made 
regarding causation.  Rating is based on the most 
severe and/or frequent symptom.  
“Tell me if you have had any of the following 
physical symptoms in the past week (READ LIST): 
dry mouth,  gas or wind,  indigestion or upset 
stomach,  diarrhea,  constipation, cramps,  
belching or burping,  heart palpitations,  headache,  
difficulty breathing,  hyperventilation, sighing,  
excessive need to urinate,  excessive sweating”.  
ASK FOR EACH PHYSICAL COMPLAINT: How 
often did you experience this problem? How much 
has the (state physical symptom) bothered you?  
Has it interfered with your activities? 
H11. ANXIETY – SOMATIC 
 (0) No symptoms 
 (1) Occurs 2 or more days per week, always mild 
 (2) Occurs 5 or more days per week with 
moderate severity, or less frequently but with 
high severity 
 (3) Occurs 5 or more days per week and is 
severe 
 (4) Any symptom that is incapacitating on a daily 
basis (5 or more days per week) 
 
Requests for or use of medications for G.I. 
symptoms (antacids, laxatives, etc.) are ignored in 
scoring.  G.I. symptoms (including constipation 
and cramps) should be rated in item 11 (Anxiety 
Somatic) and not here.  Therefore a score of ‘2’ for 
this item is obtained only with a moderate to 
marked loss of appetite.  Ignore whether dietary 
supplement is used to maintain weight.  
“How was your appetite this past week?”  
Has your appetite been poor, excessive, or 
satisfactory? Have you been skipping meals or 
have you had to force yourself to eat?  Have 
others had to urge you to eat? IF YES: How often?  
In the past week, have you had a heavy feeling in 
your stomach? IF YES: How often? 
H12. SOMATIC SYMPTOMS – Gastrointestinal 
 (0) Any appetite loss is less than 2 days per 
week 
 (1) Mild loss of appetite at least 2 days per week, 
but eats without encouragement. Has heavy 
feeling in stomach at least 2 days per week 
 (2) Moderate to marked loss of appetite at least 5 
days per week and/or difficulty eating without 
encouragement (at least 5 days per week) 
 

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MADRS Scoring Criteria
Increased appetite which reflects a return to 
euthymia (e.g. prior weight loss) is not scored. 
Scoring of food cravings should be restricted to 
carbohydrates (starches or sugars). 
IF INCREASED APPETITE REPORTED: “In the 
past week, have you been craving any foods such 
as chocolate or other sweets or starches, like pasta 
or potatoes?” 
In the past week, have you been eating more than 
you should?  IF YES:  Was this a slight or definite 
increase?  Did this occur every day? 
H27. INCREASED APPETITE 
 (0) No increase in appetite or food intake and no 
specific food craving  
 (1) Slight increase in appetite (for at least 2 days) 
and/or specific food craving 
 (2) Definite and marked increase in food intake 
 
MADRS scoring should be based on the questioning 
described in the previous item. 
 
M5. REDUCED APPETITE 
 (0) Normal or increased appetite. If reduced 
appetite, occurs less than 2 days/wk 
 (1) 
 (2) Mild loss of appetite 2 or more days per week 
 (3) 
 (4) Marked loss of appetite 5 or more days. Food 
is tasteless at least 5 or more days per week 
 (5) 
 (6) Pervasive loss of appetite throughout the 
week. Eats only with encouragement by others or 
by forcing oneself 

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HRSD Scoring Criteria
MADRS Scoring Criteria
SOMATIC SYMPTOMS (Weight, General somatic, Libido, Anergia) 
This item is scored only for weight loss in the last 
week and regardless of weight loss during the 
episode. It is most easily assessed by serial 
weighing. If the patient is deliberately dieting, 
always rate ‘0’. If serial weighing is not available, 
determine if the patient can provide an estimate of 
weight change during the past week. 
“Do you think you have lost any weight in the past 
week?” IF YES: “How much did you lose?” 
IF UNSURE: Do you think your clothes fit more 
loosely on you? 
IF WEIGHT LOSS REPORTED: Were you trying to 
lose weight by dieting? 
H16. LOSS OF WEIGHT 
  (0) Less than one pound weight loss 
  (1) 1-2 pounds weight loss 
  (2) Greater than 2 pounds weight loss 
OR if patient cannot report a specific change, ask if 
clothing fits differently, etc. If so: 
 (0) Weight loss unlikely 
 (1) Weight loss probable and minimal 
 (2) Weight loss definite and significant 
 
 
Note: Headache was scored in HRSD item 11 
(Anxiety Somatic). Do not score headache here. 
“How has your energy been this past week? Have 
you felt tired? How often have you felt tired? Were 
you so tired that you felt as if you were dragging 
through the day or had to nap? 
This past week, did you feel heaviness in your 
limbs, back, or head? Did you have any aches or 
pains this week? 
What about backaches or muscle aches? “ 
H13. SOMATIC SYMPTOMS – GENERAL 
 (0) Reports no fatigue, loss of energy, or 
heaviness in limbs, back, or head. No report of 
backache or muscle aches 
 (1) Report of a non-specific symptom that occurs 
at least 2 days per week 
 (2) Report of a clear-cut symptom (e.g., piercing 
lower back pain) that occurs at least 2 days per 
week. Marked loss of energy or fatigue at least 5 
days per week 
 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
Scoring of this item will overlap considerably with 
item 13, Somatic Symptoms General. Which 
includes assessment of fatigue or tiredness. Scoring 
Anergia is based only on the frequency and severity 
of fatigue. 
IF TIREDNESS OR FATIGUE REPORTED: make 
inquiries for the anergia item. 
In the past week, have you felt exhausted much of 
the time? Did you get tired very easily? How often 
did this occur? 
IF HEAVINESS OF LIMBS REPORTED: 
In the past week, have your arms or legs felt like 
“lead”? How often did this occur? 
H25. Anergia 
 (0) No evidence of tiring quickly or excessive 
fatigue during the week (i.e., less than 2 days)  
 (1) Reports mild fatigue or easily tiring, may 
occasionally nap, occurs at least 2 days per 
week. 
 (2) Reports feeling exhausted much of the time 
(at least 5 days per week), may nap frequently, 
tires quickly. Spontaneous report adds 
confidence in a rating of “2”, but is not required. 
SOMATIC SYMPTOMS (Libido, Hypochondriasis)
This item focuses on loss of libido. Other “genital” 
symptoms in men or women (e.g., menstruation 
disturbance in women) are not scored. For patients 
without a current sexual partner, it is important to 
inquire about sexual fantasies, masturbation, etc. If 
no libido during extended period of euthymia prior to 
episode, score as “0”. 
“This past week, how has your interest in sex been? 
We are not discussing whether you actually had 
sexual activity, but your interest in sex, your desire 
for sexual activity.” 
IF LACK OF INTEREST REPORTED:Did you lack 
interest in sex throughout the week? 
H14. GENITAL SYMPTOMS 
 (0) No loss of libido 
 (1) Mild or moderate loss of libido. Diminished or 
modest sexual interest or behavior 
 (2) Severe loss of libido. Virtually no interest or 
sexual behavior on a daily basis (at least 5 days 
per week) 

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HRSD Scoring Criteria
MADRS Scoring Criteria
In rating this item, health should be defined broadly 
(i.e., the patient does not have to be concerned 
about having a specific disease). Concerns beyond 
those appropriate for actual illnesses are the 
domain of inquiry. Definite disturbances may be 
apparent before the interview progresses to this 
item. If not, inquire about the patient's physical 
health in domains not already sampled. 
“Do you have problems with your physical health? 
This past week, how often did you find yourself 
thinking about your physical health or any physical 
problems you may have?” 
Did you complain frequently to others about your 
physical health? 
This past week, did you ask others for assistance or 
advice because of your physical problems? If so, 
how often? 
IF POSSIBLY DELUSIONAL ASK: 
Have you seen a physician for any of these 
problems? 
Was a diagnosis made? 
H15. HYPOCHONDRIASIS 
 (0) No concern or appropriate concerns about 
health status 
 (1) Patient is absorbed or inappropriately worried 
about health. This may be mild, non-specific, 
and fleeting (at least 2 days per week) 
 (2) The excessive concern is a preoccupation, 
brooding with specific concerns more days than 
not (at least 5 days per week). Differs from (1) in 
severity, specificity, and/or persistence 
 (3) Patient spontaneously and frequently 
complains of physical problems or frequently 
asks for medications, evaluations, or health 
advice 
 (4) Somatic delusions; e.g., cancer, GI or GU 
blockage, rotting, etc.) 

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HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Psychic Anxiety, Tension,)
Introductory Comment: “Now I am going to ask you some questions about your feelings about yourself. I would like you to think about the feelings and thoughts 
you’ve had about yourself during the past week.”
In scoring this item, determine if patient meets 
criteria for 1. If so, and patient does not meet criteria 
of 2, give a score of 1 and go to the next item. If 
patient meets criteria for both 1 and 2, determine if 
they meet criteria for 3 (and so on). 
“Have you been feeling especially tense or irritable 
this past week? IF YES: How often were you feeling 
this way?” 
“This past week, have you been argumentative or 
impatient?” IF YES: “How often were you feeling 
this way?” 
“This past week, have you been worrying a lot about 
little things?” IF YES: “What have you been 
worrying about?” 
H10. ANXIETY – PSYCHIC  
 (0) Patient neither reports nor nonverbally 
conveys excessive anxiety, worry fear, or 
irritability. Any irritability, tension, anxiety 
experienced < 2 days per week and only mild in 
severity 
 (1) On direct inquiry, patient reports feelings of 
anxiety, tension, or irritability (i.e., free-floating 
anxiety) for 2 or more days. These feelings, 
however mild, are disproportionate or 
inappropriate relative to the situation 
 (2) A) Meets criteria for (1) and anxiety is 
expressed nonverbally in the interview (e.g., 
apparent in face or speech: furrowed brow, 
hand-wringing, pacing, fidgeting), OR B) Patient 
reports feelings of at least moderate anxiety, 
tension or irritability for 5 or more days or the 
patient worries excessively about minor or 
insignificant matters (i.e., parking ticket) for 5 or 
more days 
 (3) Patient reports feelings of at least moderate 
anxiety, tension or irritability for 5 or more days 
and anxiety is expressed nonverbally in the 
interview 
 (4) Fears or anxiety are expressed without 
questioning (verbally or nonverbally) and are 
severe for 5 or more days 
 
 

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HRSD Scoring Criteria
MADRS Scoring Criteria
This item overlaps considerably in content with the 
HRSD Psychic Anxiety item. Scores increase from 
ill-defined feelings of discomfort, edginess, turmoil, 
and mental tension to panic, dread, or anguish. 
Higher scores are given as a function of intensity 
and frequency. Discomfort refers to apprehensive 
feelings and thoughts and other worries and not to 
physical complaints. 
“During the past week, have you felt panicky?” 
IF YES: How often did you feel this way and how 
did you cope with these feelings? 
 
M3. INNER TENSION  
 (0) Inner tension experienced less than 2 days 
per week and mild in presentation 
 (1)  
 (2) Feelings of edginess, inner turmoil, etc. at 
least two days per week, but dissipate 
spontaneously. These feelings/thoughts are mild. 
 (3)  
 (4) Continuous feelings (≥5 days) of inner tension 
or discomfort. Intermittent panic (> 2 days) 
requiring isolation or a change in medication 
status 
  (5)  
  (6) Pervasive (≥5 days) and unrelenting feelings 
of dread or anguish. Feelings of panic are 
overwhelming 
PSYCHIC SYMPTOMS (Diurnal Variation, Depersonalization, Paranoia) 
Diurnal variation may pertain to any of the 
symptoms of depression, not just mood. Morning is 
defined from awakening until noon; evening is 
defined from 5PM until midnight. 
“During the past week, have you regularly felt worse 
at any particular part of the day? Has it been in the 
morning, afternoon, or evening?” 
IF YES: How much worse do you feel at this time? A 
little or a lot worse? 
How many days in the last week did this happen? 
H18. DIURNAL VARIATION  
 (0) No difference in perceived symptoms in the 
morning relative to the evening 
 (1) A mild to moderate difference noted at least 2 
days per week 
(note whether AM or PM is worse) 
 AM      PM 
 (2) A marked or severe difference noted at least 
5 days per week  
(note whether AM or PM is worse) 
 AM      PM 
 
 
 

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HRSD Scoring Criteria
MADRS Scoring Criteria
Patients with these symptoms typically recognize 
them; while those without the symptoms may have 
difficulty understanding the inquiries. Patients who 
state that they do not feel like themselves or do not 
understand or believe why the illness is happening 
to them are not reporting symptoms of 
depersonalization or derealization. Rather the focus 
is on feelings of unreality. There should be clear-cut 
feelings that the surroundings or other people are 
unreal or that the patient is out of the body. 
“During the past week, have you ever had the 
feeling that some things are unreal, or that you are 
living in a dream, or cut off from other people in 
some strange way? Do you feel real to yourself? Do 
the things around you look and sound real? Have 
you had out of the body experiences? Have you felt 
like you've been watching yourself do things?” 
IF YES TO ANY OF THE ABOVE: Tell me about 
these feelings. How often has it happened? How 
bad has it been? 
IF YES: How many days during the past week did 
you have these feelings? 
IF YES: Did it interfere with work or home life? 
H19. DEPERSONALIZATION/DEREALIZATION 
 (0) No symptoms 
 (1) Mild or infrequent (2 days per week)  
 (2) Frequent (at least 5 days per week) and of 
moderate severity 
 (3) Frequent and severe, often experienced as 
intrusive or disturbing  
 (4) Frequent, severe, and interferes with daily 
activities 
 

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HRSD Scoring Criteria
MADRS Scoring Criteria
The focus is on a feeling or belief of malevolence on 
the part of others and suspiciousness by the patient. 
Determine whether others are against or out to 
harm the patient. If the patient states that others are 
talking about him/her, this should be discussed in 
detail. If others restrict their statement to the patient 
being “bad” or “unworthy”, determine what motive is 
attributed by the patient to those make these 
comments. If these others are only discussing what 
the patient believes to be true and deserved, the 
information impacts on ratings of guilt, 
worthlessness, etc. If others are believed to be 
malevolent in their discussions or actions, also rate 
with respect to paranoia, e.g., they are spreading 
rumors to damage the patient's reputation. 
“During the past week, have you felt that anyone 
was trying to give you a hard time or hurt or harm 
you in any way?” 
Did you feel that people were talking behind your 
back? 
Did you feel that people had bad intentions towards 
you? 
IF YES TO ANY OF THE ABOVE: Tell me about it. 
Who and why? 
Have you felt that you are being singled out or 
persecuted? 
H20. PARANOID SYMPTOMS 
 (0) No evidence of excessive concern about 
others’ motives or behavior 
 (1) Some, perhaps fleeting, suspiciousness (at 
least 2 days per week). For example, excessive 
concerns about the interview’s usage or the 
motives of others 
 (2) More persistent or intense suspiciousness (at 
least two days per week). May have impact on 
behavior, e.g., avoids contact with others 
 (3) Relatively fixed idea that others are out to 
harm or have malevolent intentions (at least 5 
days per week)  
 (4) Paranoid ideation is clearly delusional 
(regardless of duration), e.g., a paranoid system 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Obsessions and Compulsions, Rejection, Sensitivity) 
Depressed patients frequently ruminate about 
mood-congruent themes such as guilty acts, 
inadequacy, life stressors, etc. Such rumination 
should be distinguished from obsessions (i.e., ego 
dystonic), and should not be scored for this item. 
Obsessive thoughts should be recognized as 
originating in the patient’s mind, but also as being 
unwanted and alien. 
They should be associated with anxiety. There 
should be some struggle against them, i.e., 
substituting another thought or act (compulsion). 
Compulsions are repetitive, intentional behaviors, 
performed in a ritualistic fashion or stereotyped 
fashion, often designed to neutralize an obsession 
or other dreaded situation, but the compulsive 
activity is not realistically connected with the 
stimulus or is clearly excessive. The patient 
generally recognizes that the behavior is excessive 
or unreasonable. 
“During the past week, have there been things you 
have had to do over and over again, like checking 
the locks on doors several times or washing your 
hands?” IF YES: “Please give me an example.” 
“During the past week, have you had any thoughts 
that do not make sense to you but that kept running 
over and over in your mind?” IF YES: “Please give 
me an example.” 
Did you have any disturbing thoughts that you could 
not stop thinking about? If YES, please give me an 
example. 
If YES to any of the above: How often in the past 
week did you have these (repetitive behaviors or 
disturbing thoughts)? 
H21. OBSESSIONAL AND COMPULSIVE 
SYMPTOMS 
 (0) No evidence for obsessions or compulsions 
 (1) Obsessions or compulsions that are mild in 
severity (e.g., infrequent or of short duration 
during the day) and occur at least 2 days per 
week 
 (2) Obsessions and compulsions that are severe 
(e.g., occupying hours, interfering with 
functioning) occurring at least 2 days per week 
or of moderate severity and occurring 5 or more 
days per week 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
“During the past week, have you felt especially 
concerned about what other people think about 
you? During the past week, have your feelings been 
easily hurt?” 
During the past week, have you felt particularly 
sensitive to rejection by other people? 
IF YES TO ANY OF THE ABOVE, ASK: How so? 
How often did you feel this way? Did these feelings 
get in the way of your socializing with others? 
H28. REJECTION SENSITIVITY 
 (0) No evidence in the past week of excessive 
sensitivity to or fear of rejection 
 (1) Mild or fleeting sensitivity to rejection 
experienced on at least 2 days. 
 (2) Clear-cut rejection sensitivity that is persistent 
 (3) Severe and persistent rejection sensitivity that 
leads to social isolation or other functional 
consequences. 
 
PSYCHIC SYMPTOMS (Depressed Mood, Apparent Sadness) 
In rating this item it is important to distinguish 
between depressed mood and anhedonia. 
Descriptions of depressed mood should reflect 
feeling blue, sad, black, tearful, gloomy, dejected, 
despondent, hopeless, worthless, etc. Descriptions 
of feeling nothing, empty, hollow, dead, blah, etc., 
do not qualify as depressed mood. 
“What has your mood been like this past week?” 
DEPENDING ON DESCRIPTION, ASK: 
“Have you been feeling sad, blue, or unhappy? OR 
has your mood been completely black or gray?” 
How many days this past week did you feel 
depressed? 
Have you had any periods in the past week when 
your mood lightened, when you felt better? 
Have you been crying? IF YES: How often have you 
cried this past week? 
H1. DEPRESSED MOOD 
 (0) Absent: Feels at most mildly sad and for less 
than two days per week. 
 (1) Depressed feelings elicited only on 
questioning and feels depressed at least two 
days per week. 
 (2) Depressed mood elicited on questioning is of 
at least moderate severity and present 5 or more 
days per week 
OR, Patient spontaneously reports depressed 
mood that is of at least moderate severity two or 
more days per week. 
 (3) Depressed mood is communicated 
nonverbally in the interview and/or depressed 
mood of at least moderate severity is 
experienced daily. Patient is tearful in interview. 
 (4) Patient interview is dominated by reports of 
depression which is experienced daily. 
 
 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
This item is scored solely on the patient’s 
appearance during the interview and not on their 
report of mood state. Thus, facial expression, 
posture, quality and quantity of speech are all 
considered when inferring mood state. Included in 
the scoring is the extent to which apparent sadness 
or despondency fails to lift with positive events 
(“inability to brighten up”). To score this aspect, 
determine whether emotional expression brightens 
when discussing positive topics, pleasurable 
activities, or jokes. 
 
M1. APPARENT SADNESS 
 (0) No appearance of sadness. 
 (1) 
 (2) Some physical expressions of sadness, but 
not pervasive, and dissipates spontaneously or in 
response to "good news" (e.g., jokes, gifts). 
 (3) 
 (4) Expressions of sadness dominant during the 
interview, and are at least partially resistant to 
lifting. 
 (5) 
 (6) Pervasive expressions of sadness such that 
the patient appears despondent and 
unresponsive 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Emotional Blunting) 
This item assesses 3 dimensions of abnormal 
subjective experience: (I) reduced interest in 
surroundings and activities (disinterest); (II) reduced 
ability to react with “adequate emotion to 
circumstances or people” (emotional reactivity); (III) 
reduced capacity for pleasure (anhedonia). 
Earlier discussion for “Work and Activities” and 
“Lassitude” may provide the needed information for 
scoring interest in surroundings. 
“During this past week was there a change in your 
interest in your surroundings, world events, hobbies, 
friends, or anything else? Is your interest at its usual 
level?” 
Compared to usual, has your emotional reactions to 
things and people around you been blunted this 
past week? Do you feel you are more or less 
reactive than usual? 
Tell me about your ability to experience pleasure? 
This past week could you experience the same 
degree of pleasure in activities and people that you 
had in the past? If not, how has this capacity 
changed? 
 
M8. INABILTY TO FEEL 
 (0) Typical degree of interest in surroundings and 
other people; no diminishment in emotional 
reactivity; preserved or enhanced capacity to 
experience pleasure in all realms. Any 
diminishment in these areas experienced less 
than 2 days in the week 
 (1)  
 (2) Reduced interest, emotional reactivity, or 
capacity for pleasure. Any of these reductions is 
mild and none are pervasive (i.e., less than 5 
days per week) 
 (3)  
 (4) Loss of interest, reduced reactivity, or 
anhedonia are pervasive and of at least 
moderate intensity. Any one of the three qualify 
for a rating at this level 
 (5)  
 (6) Pervasive and severe deficits in any one of 
the three: profound lack of interest; emotional 
flatness (total lack of reactivity); complete 
anhedonia. Any marked deficit for 5 or more days 
per week 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Helplessness, Hopelessness)
It is sometimes difficult for patients to distinguish 
between “helplessness” and “hopelessness”. The 
helplessness item focuses on 2 domains: The need 
for urging or assistance in carrying out activities of 
daily life and the subjective feeling of needing 
assistance or help in carrying out activities. During 
the interview, patients report being “overwhelmed” 
by their obligations and “no longer able to cope” can 
be taken as statements of helplessness (either 
spontaneous or elicited). It is often useful to follow-
up these reports with direct inquiries, such as, “Do 
you feel you need assistance to accomplish these 
things?” 
“During the past week, did you feel you had trouble 
coping with routine activities? 
Were there times when you felt overwhelmed and 
unable to complete your activities or 
responsibilities?” 
Were these feelings so bad that you would say you 
felt helpless? 
Did other people have to encourage or urge you to 
tend to your work (school) or household 
responsibilities? 
During the past week, did you feel that you were 
giving up trying to cope with life? 
During the past week, did you need the physical 
help of others to complete simple activities like 
grooming, dressing, or eating? 
H22. HELPLESSNESS 
 (0) No evidence of subjective or objective 
helplessness 
 (1) Patient reports inability or feelings of inability 
to accomplish usual tasks only on inquiry, or the 
patient reports the need or desire for the 
assistance of others to accomplish usual tasks 
(personal hygiene, school work, household 
chores, or job-related duties) 
 (2) Patient spontaneously volunteers feelings of 
being overwhelmed or unable to cope with usual 
tasks 
OR, 
on inquiry, patient reports at least moderate 
feelings of helplessness (overwhelmed, unable 
to cope, need for help) that are manifest at least 
5 days per week 
 (3) Patient requires the urging or guidance of 
others to complete usual tasks (personal 
hygiene, school work, household chores, or job-
related duties) 
 (4) Patient requires the physical assistance of 
others for elementary tasks of daily living 
(personal hygiene, eating, dressing, grooming) 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
This item focuses on pessimistic feelings or despair 
about the future, and specifically the probability of 
getting well or staying well 
“During the past week, were you optimistic or 
pessimistic about your future?” 
Did you doubt that things would improve for you? IF 
YES: 
When people tell you that you will be well (or stay 
well), do you feel reassured? 
If your doctor told you he/she was optimistic about 
your prospects would you feel reassured? 
IF NO: Do you have a feeling of despair or 
discouragement about the future that simply will not 
go away? 
H23. HOPELESSNESS 
 (0) No feelings of pessimism 
 (1) Patient is more optimistic than pessimistic 
about getting or staying well, but has doubts (at 
least 2 days per week) 
 (2) Persistent pessimism or hopelessness (at 
least 5 days per week), but states that can be 
reassured by others 
 (3) Reports discouragements, despair, and/or 
pessimism which is persistent (at least 5 days 
per week) and cannot be relieved by 
reassurance 
 (4) Interview is dominated by frequent, repetitive 
and spontaneous statements of despair and 
hopelessness which cannot be dispelled 
 
 
 

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Interview Guide 
HRSD Scoring Criteria 
MADRS Scoring Criteria 
PSYCHIC SYMPTOMS (Worthlessness, Pessimism, Reported Sadness, Insight
Scoring of this item is based on three dimensions. 
Any delusion of worthlessness merits a rating of “4” 
regardless of whether spontaneously reported or 
elicited on inquiry. Spontaneous reports of self-
esteem deficits merit a rating of “2” or “3” depending 
on severity/persistence. Non-delusional feelings of 
inferiority only manifested on direct inquiry merit a 
rating of “1” or “2”, depending on 
severity/persistence. 
“During the past week, have you felt that you are as 
good as other people whom you know and 
respect?” 
Have you felt that others are better than you? 
IF YES TO EITHER, ASK: 
During this past week, did you feel that you are “no 
good” or “inferior”? Would you say that you had 
feelings of being “worthless”? 
IF YES TO EITHER, ASK: 
How often did you feel this way during the past 
week? 
Do you feel that you are worth nothing at all, either 
to yourself or others? 
H24. WORTHLESSNESS 
 (0) No loss of self-esteem or feelings of inferiority 
 (1) Poor self-esteem or feelings of inferiority only 
reported on direct inquiry 
 (2) Spontaneous report of diminished self-esteem 
or inadequacy, at least some of the time ( 2 
days per week), 
OR, 
Feelings of inferiority or loss of self-esteem that 
are persistent and severe but only manifest on 
direct inquiry 
 (3) Spontaneous reports of more severe and 
persistent loss of self-esteem and feelings of 
inferiority. Notions of worthlessness should be 
pervasive, i.e., patient believes that there is 
nothing worthwhile about them 
 (4) Delusion of worthlessness (or other self-
deprecatory delusion) regardless of 
spontaneous or elicited report 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
The MADRS Pessimistic thoughts item combines 
ideation about negative projections for the future 
(hopelessness) with negative thoughts about the 
self (worthlessness). Score this item based upon the 
most flagrant or severe symptoms. Information 
obtained with the HRSD guilt, suicide, paranoid, 
hopelessness, and worthlessness items need to be 
considered. A patient with delusions of self-reproach 
but optimistic about the future would still receive a 
score of ‘6’. 
Additional questions are not usually unnecessary. 
Note the scoring conventions. 
 
M9. PESSIMISTIC THOUGHTS 
 (0) Not pessimistic about the future two or more 
days per week; no feelings of inferiority, guilt, or 
failure two or more days per week. 
 (1) 
 (2) Occasional pessimistic thoughts about the 
future or feelings of inferiority or self-reproach 2 
days per week 
 (3) 
 (4) Persistent pessimism and/or feeling of 
inferiority, guilt, or failure the majority of days in 
the week 
 (5) 
 (6) Pervasive negativism of delusional 
proportions. Psychotic thinking pertains to self 
(e.g., guilt) and/ or prospects for the future 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Guilt, Suicidality) 
For ratings of ‘2-3’ feelings, thoughts, rumination, or 
beliefs should be present at least 2 days during the 
week. Any relevant hallucination merits a rating of 
‘4’. 
“This past week, have you been particularly self-
critical? 
Did you feel that you have done things wrong? 
Have you felt like you have let other people down or 
let yourself down in some way?” 
IF YES TO ANY OF THE ABOVE: “Please give me 
examples of these critical thoughts.” 
During the past week, have you felt guilty about 
anything you’ve done or not done? What about 
things that happened a long time ago? 
IF YES: What sort of things did you feel guilty 
about? 
Have you thought that you’ve brought this 
depression on yourself in some way? 
IF YES: How so? 
Have you felt that you are being punished in some 
way? IF YES: How so? 
H2. FEELINGS OF GUILT 
 (0) No feelings or ideas of guilt 
 (1) Regardless of intensity, feelings of self-
reproach or the belief of being a disappointment 
to others 
 (2) Explicit ideas of being guilty or rumination 
about past mistakes or sins 
 (3) Believes the depression is a punishment, 
even if due to religious conviction, or has 
delusions of guilt, regardless of type 
 (4) Auditory or visual hallucinations of an 
accusatory or denunciatory nature. 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
“During the past week, did you have thoughts that 
life is not worth living? 
During this week, did you wish that you were dead? 
Did you have thoughts in which you imagined 
yourself dead? 
During the past week, did you have thoughts of 
hurting or killing yourself?” 
IF YES: What did you think about? Do you have a 
plan for hurting or killing yourself? 
During this past week, did you do anything to hurt 
yourself? 
H3. SUICIDE 
 (0) Believes life worth living and denies more 
than occasional thoughts of death 
 (1) Feels life is not worth living, but has not 
contemplated or wished death during the past 
week. 
 (2) Persistent wish to die and/or more than 
occasional thoughts about death to self (e.g., 
has thought about death but would not do it 
because of family or religious concerns) 
 (3) Clear-cut suicidal ideation or gesture (e.g., 
definite plan, small cuts, starts suicide attempt 
but does not follow through, practices suicidal 
plan, purchases items for plan) 
 (4) Any serious attempt, whether planned or 
impulsive 
 
 
 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
 
 
M10. SUICIDAL THOUGHTS 
 (0) Generally feels that life is worth living. At most 
has passing thoughts of death at most one day 
per week. 
 (1) 
 (2) Is tired of living and has thought or wishes for 
death  2 days per week. However, has no plan 
or intent for suicide 
 (3) 
 (4) Has a persistent belief that life is not worth 
living and would rather be dead. May believe that 
suicide is a potential outcome. These thoughts 
and feelings occur at least 5 days per week. 
However, has no specific plan 
 (5) 
 (6) Has an explicit plan and may be actively 
preparing for suicide attempt. Desire to commit 
suicide is persistent and the belief that life is not 
worth living is unwavering. 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
PSYCHIC SYMPTOMS (Reported Sadness, Insight)
Item is scored in relation to patient report of 
depressed mood, regardless of congruence with 
physical expression. Depressed mood includes 
feeling low, despondent, helpless, and hopeless. 
Thus, this item combines elements of the mood, 
helplessness, and hopelessness items of HRSD. 
The scoring on the 0-6 scale should reflect a 
judgment about the intensity of feelings, their 
frequency and duration (pervasiveness) and 
imperviousness to influence by positive events 
(reassurance, expressions of support, etc.). Intense 
and pervasive feelings of any type (sadness or 
hopelessness) merit a score of ‘6’. 
After inquiring about mood, hopelessness and 
helplessness, determine whether these feelings are 
lessened by significant others, positive events, etc. 
“Are these (sad, hopeless, helpless) feelings 
constant or do you feel better at times? 
When you feel better is that due to the support you 
get from others? 
…or due to good things that happen to you at the 
time? 
…or your own efforts to get out of that mood? 
 
M2. REPORTED SADNESS 
 (0) Only occasional feelings of sadness (low, 
blue), hopelessness, or helplessness that are in 
keeping with the circumstances 
 (1) 
 (2) Sad or low two or more days per week, but 
intensity mild and/or readily feels better given 
positive interactions, events, or by own efforts 
 (3) 
 (4) Marked sadness or gloominess the majority of 
days in the week which impacts on activities or 
others. External circumstances may still influence 
mood. 
 (5) 
 (6) Pervasive and unvarying sadness, misery, or 
despondency. May have the feeling of being 
beyond hope or help. Mood is not responsive to 
environmental events 

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Interview Guide 
HRSD Scoring Criteria
MADRS Scoring Criteria
Before inquiring and scoring this item, the rater 
should determine whether the patient is 
sufficiently symptomatic to be said to have an 
“illness” to be acknowledged and explained. 
Patients with minimal Symptomatology 
automatically score ‘0’ on this item (and 
questions can be skipped). 
This item can generally be rated without asking 
specific questions. However, if insight is unclear 
ask... 
“In your own words, how would you describe or 
explain why you are (being evaluated or 
receiving treatment) here?” 
Do you believe you are depressed? 
IF YES: What is the cause of your depression? 
H17. INSIGHT 
 (0) Acknowledgement of depression or 
psychological or nervous problem or not ill by 
interviewer judgment 
 (1) Acknowledges illness but attributes it to 
unlikely factors, such as virus, overwork, 
climate, diet, etc. 
 (2) Denies being depressed, having a 
psychological or nervous problem, and is 
assessed by the rater to be significantly 
symptomatic (depressed) 
 
OBSERVED MOTOR SYMPTOMS (Retardation, Agitation)
The HRSD items for retardation and agitation should be completed by observation of the patient’s behavior during the interview. Subjective experience of being 
“slowed down” or “agitated” is not considered in scoring these items. While these 2 items are scored only on the basis of observed behavior, it is important to 
determine that the abnormal motor behavior is not directly attributable to another medical condition (e.g., tremor in Parkinson’s disease) or habitual or usual for 
the patient. Therefore it is important to inquire “I see that you have this ‘state the behavior’. What is it due to?” 
 
H8. RETARDATION 
 (0) Expected rate of speech and activity. 
Response time to questions within normal 
limits, speech rate appropriate, and no 
evidence of diminished gesturing or other 
motor activity 
 (1) Suggestion of slowing in speech or motor 
activity 
 (2) Obvious slowing in motor behavior, 
response time to questions, and/or speech 
 (3) Interview is strained because of poverty of 
speech or slowness of response 
 (4) Stupor 
 
 

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Interview Guide 
HRSD Scoring Criteria 
MADRS Scoring Criteria 
 
H9. AGITATION 
 (0) No evidence of fidgetiness or nervous habits 
 (1) Fidgetiness 
 (2) Playing with hands or hair 
 (3) Moving about, can’t sit still. 
 (4) Repetitive and often continuous excessive 
motor activity, typically involving hand-
wringing, nail biting, rocking, rubbing of legs, 
pacing, hair-pulling, lip biting, etc. 
 
 
 
 
 
 
 
Total HRSD Score  
 
 
 
 
 
 
SC/Rater Signature _________________________________________    Date ___________________________

  
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
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CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 21_Version 4.1_02212014  
 
 
 
Page 1 of 4 
 
Copyright © 1987 by Aaron T. Beck. It is illegal to photocopy or otherwise reproduce this instrument.  Qualified individuals may obtain this 
instrument by contacting The Psychological Corporation, San Antonio, Texas at 1-800-228-0752. 
Form 21 - Beck Depression Inventory 
 
 
 
 
 
 
 
On this questionnaire are groups of statements.  Please read each group of statements carefully.  Then 
pick out the one statement in each group which best describes the way you have been feeling the 
PAST WEEK, INCLUDING TODAY!  Circle the number beside the statement you picked.  If several 
statements in the group seem to apply equally well, circle each one.  Be sure to read all the statements 
in each group before making your choice. 
 
1 
0 
I do not feel sad.  
 
1 
I feel sad. 
 
2 
I am sad all the time and I can't snap out of it. 
 
3 
I am so sad or unhappy that I can't stand it. 
 
 
 
2 
0 
I am not particularly discouraged about the future. 
 
1 
I feel discouraged about the future. 
 
2 
I feel I have nothing to look forward to. 
 
3 
I feel that the future is hopeless and that things cannot improve. 
 
 
 
3 
0 
I do not feel like a failure. 
 
1 
I feel I have failed more than the average person. 
 
2 
As I look back on my life, all I can see is a lot of failures. 
 
3 
I feel I am a complete failure as a person. 
 
 
 
4 
0 
I get as much satisfaction out of things as I used to. 
 
1 
I don't enjoy things the way I used to. 
 
2 
I don't get real satisfaction out of anything anymore. 
 
3 
I am dissatisfied or bored with everything. 
Circle Visit Below: 
Baseline 
Acute Treatment Phase Sessions:  
5 
10 
15 
20 
25 
30 
Follow-up Phase Weeks: 
 
4 
8 
12 
16 
20 
24 

Site __ __     Participant # __ __ __ __ __    Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 21_Version 4.1_02212014 
 
 
 
Page 2 of 4 
 
Copyright © 1987 by Aaron T. Beck. It is illegal to photocopy or otherwise reproduce this instrument.  Qualified individuals may obtain this 
instrument by contacting The Psychological Corporation, San Antonio, Texas at 1-800-228-0752. 
 
 
 
 
5 
0 
I don't feel particularly guilty. 
 
1 
I feel guilty a good part of the time. 
 
2 
I feel quite guilty most of the time. 
 
3 
I feel guilty all of the time. 
 
 
 
6 
0 
I don't feel I am being punished. 
 
1 
I feel I may be punished. 
 
2 
I expect to be punished. 
 
3 
I feel I am being punished. 
 
 
 
7 
0 
I don't feel disappointed in myself. 
 
1 
I am disappointed in myself. 
 
2 
I am disgusted with myself. 
 
3 
I hate myself. 
 
 
 
8 
0 
I don't feel I am any worse than anybody else. 
 
1 
I am critical of myself for my weaknesses or mistakes. 
 
2 
I blame myself all the time for my faults. 
 
3 
I blame myself for everything bad that happens. 
 
 
 
9 
0 
I don't have any thoughts of killing myself. 
 
1 
I have thoughts of killing myself, but I would not carry them out. 
 
2 
I would like to kill myself. 
 
3 
I would kill myself if I had the chance. 
 
 
 
10 
0 
I don't cry anymore than usual. 
 
1 
I cry more now than I used to. 
 
2 
I cry all the time now. 
 
3 
I used to be able to cry, but now I can't cry even though I want to. 

Site __ __     Participant # __ __ __ __ __    Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 21_Version 4.1_02212014 
 
 
 
Page 3 of 4 
 
Copyright © 1987 by Aaron T. Beck. It is illegal to photocopy or otherwise reproduce this instrument.  Qualified individuals may obtain this 
instrument by contacting The Psychological Corporation, San Antonio, Texas at 1-800-228-0752. 
 
 
 
 
11 
0 
I am no more irritated now than I ever am. 
 
1 
I get annoyed or irritated more easily than I used to. 
 
2 
I feel irritated all the time now. 
 
3 
I don’t get irritated at all by the things that used to irritate me. 
 
 
 
12 
0 
I have not lost interest in other people. 
 
1 
I am less interested in other people than I used to be. 
 
2 
I have lost most of my interest in other people. 
 
3 
I have lost all of my interest in other people. 
 
 
 
13 
0 
I make decisions about as well as I ever could. 
 
1 
I put off making decisions more than I used to. 
 
2 
I have greater difficulty in making decisions than before. 
 
3 
I can't make decisions at all anymore. 
 
 
 
14 
0 
I don't feel I look any worse than I used to. 
 
1 
I am worried that I am looking old or unattractive. 
 
2 
I feel that there are permanent changes in my appearance that make me look 
unattractive. 
 
3 
I believe that I look ugly. 
 
 
 
15 
0 
I can work about as well as before. 
 
1 
It takes an extra effort to get started at doing something. 
 
2 
I have to push myself very hard to do anything. 
 
3 
I can't do any work at all. 
 
 
 
16 
0 
I can sleep as well as usual. 
 
1 
I don't sleep as well as I used to. 
 
2 
I wake up 1-2 hours earlier than usual and find it hard to get back to sleep. 
 
3 
I wake up several hours earlier than I used to and cannot get back to sleep. 
 
 
 

Site __ __     Participant # __ __ __ __ __    Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 21_Version 4.1_02212014 
 
 
 
Page 4 of 4 
 
Copyright © 1987 by Aaron T. Beck. It is illegal to photocopy or otherwise reproduce this instrument.  Qualified individuals may obtain this 
instrument by contacting The Psychological Corporation, San Antonio, Texas at 1-800-228-0752. 
17 
0 
I don't get more tired than usual. 
 
1 
I get tired more easily than I used to. 
 
2 
I get tired from doing almost anything. 
 
3 
I am too tired to do anything. 
 
 
 
18 
0 
My appetite is no worse than usual. 
 
1 
My appetite is not as good as it used to be. 
 
2 
My appetite is much worse now. 
 
3 
I have no appetite at all anymore. 
 
 
 
19 
0 
I haven't lost much weight, if any lately. 
 
1 
I have lost more than 5 pounds. 
 
2 
I have lost more than 10 pounds. 
 
3 
I have lost more than 15 pounds. 
 
 
I am purposely trying to lose weight by eating less. 
Yes      No 
 
 
 
20 
0 
I am no more worried about my health than usual. 
 
1 
I am worried about physical problems such as aches and pains; or upset 
stomach; or constipation. 
 
2 
I am very worried about physical problems, and it's hard to think of much else. 
 
3 
I am so worried about my physical problems that I cannot think about anything 
else. 
 
 
 
21 
0 
I have not noticed any recent change in my interest in sex. 
 
1 
I am less interested in sex than I used to be. 
 
2 
I am much less interested in sex now. 
 
3 
I have lost interest in sex completely. 
 
 
SC Signature ______________________________________   Date ________________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
    MM 
    DD 
    YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 22_Version 4.1_02212014 
 
 
Page 1 of 2 
 
 
 
 
 
Please circle one response to each item that best describes the participant for the last 7 days. 
1. 
Sleep Onset Insomnia: 
0   Never Takes longer than 30 minutes to fall asleep. 
1   Takes at least 30 minutes to fall asleep, less than half 
the time. 
2   Takes at least 30 minutes to fall asleep, more than 
half the time. 
3   Takes more than 60 minutes to fall asleep, more than 
half the time. 
6. 
Appetite (Decreased): 
0   No change from usual appetite. 
1   Eats somewhat less often and/or lesser amounts 
than usual. 
2   Eats much less than usual and only with personal 
effort. 
3   Eats rarely within a 24-hour period, and only with 
extreme personal effort or with persuasion by 
others. 
2. 
Mid-Nocturnal Insomnia: 
0   Does not wake up at night. 
1   Restless, light sleep with few awakenings. 
2   Wakes up at least once a night, but goes back to 
sleep to sleep easily. 
3   Awakens more than once a night and stays awake for 
20 minutes or more, more than half the time. 
7. 
Appetite (Increased): 
0   No change from usual appetite. 
1   More frequently feels a need to eat than usual. 
2   Regularly eats more often and/or greater 
amounts than usual. 
3   Feels driven to overeat at and between meals. 
3. 
Early Morning Insomnia: 
0   Less than half the time, awakens no more than 30 
minutes before necessary. 
1   More than half the time, awakens more than 30 
minutes before need be. 
2   Awakens at least one hour before need be, more than 
half the time. 
3   Awakens at least two hours before need be, more 
than half the time. 
8. 
Weight (Decrease) Within The Last Two Weeks: 
0   Has experienced no weight change. 
1   Feels as if some slight weight loss occurred. 
2   Has lost 2 pounds or more. 
3   Has lost 5 pounds or more. 
9. 
Weight (Increase) Within The Last Two Weeks: 
0   Has experienced no weight change. 
1   Feels as if some slight weight gain has occurred. 
2   Has gained 2 pounds or more. 
3   Has gained 5 pounds or more. 
4. 
Hypersomnia: 
0   Sleeps no longer than 7-8 hours/night, without naps. 
1   Sleeps no longer than 10 hours in a 24 hour period 
(include naps). 
2   Sleeps no longer than 12 hours in a 24 hour period 
(include naps). 
3   Sleeps longer than 12 hours in a 24 hour period 
(include naps). 
 
10. Concentration/Decision Making: 
0   No change in usual capacity to concentrate and 
decide. 
1   Occasionally feels indecisive or notes that 
attention often wanders. 
2   Most of the time struggles to focus attention or 
make decisions. 
3   Cannot concentrate well enough to read or 
cannot make even minor decisions. 
5. 
Mood (Sad): 
0   Does not feel sad. 
1   Feels sad less than half the time. 
2   Feels sad more than half the time. 
3   Feels intensely sad virtually all the time. 
 
Form 22 – Quick Inventory of Depressive Symptomatology (Clinician-Rated) 
(QIDS-C)
Circle Visit Below: 
Baseline 
 
Acute Treatment Phase: 
5 
10 
15 
20 
25 
30 
Follow-up Phase: 
    
4 
8 
12 
16 
20 
24 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                        
 
 
  MM  
    DD 
    YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 22_Version 4.1_02212014 
 
 
Page 2 of 2 
11. Outlook (Self): 
0   Sees self as equally worthwhile and deserving as 
others. 
1   Is more self-blaming than usual. 
2   Largely believes that he/she causes problems for 
others. 
3   Ruminates over major and minor defects in self. 
14. Energy/Fatiguability: 
0   No change in usual level of energy. 
1   Tires more easily than usual. 
2   Makes significant personal effort to initiate or 
maintain usual daily activities. 
3   Unable to carry out most of usual daily activities 
due to lack of energy. 
12. Suicidal Ideation: 
0   Does not think of suicide or death. 
1   Feels life is empty or is not worth living. 
2   Thinks of suicide/death several times a week for 
several minutes. 
3   Thinks of suicide/death several times a day in depth, 
or has made specific plans, or attempted suicide. 
15. Psychomotor Slowing: 
0   Normal speed of thinking, gesturing, and 
speaking. 
1   Patient notes slowed thinking, and voice 
modulation is reduced. 
2   Takes several seconds to respond to most 
questions; reports slowed thinking. 
3   Is largely unresponsive to most questions without 
strong encouragement. 
13. Involvement: 
0   No change from usual level of interest in other people 
and activities. 
1   Notices a reduction in former interests/activities. 
2   Finds only one or two former interests remain. 
3   Has virtually no interest in formerly pursued activities. 
16. Psychomotor Agitation: 
0   No increased speed or disorganization in thinking 
or gesturing. 
1   Fidgets, wrings hands and shifts positions often. 
2   Describes impulse to move about and displays 
motor restlessness. 
3   Unable to stay seated. Paces about with or 
without permission. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature _____________________________________   Date _____________________________ 

  Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __                                                
 
 
 
MM    
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 23_Version 4.1_02212014 
 
 
Page1 of 3 
 
 
 
 
 
 
 
Form 23 - COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) 
Circle Visit Below:  
 
Screening/Baseline 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
    MM          DD 
       YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 23_Version 4.1_02212014 
 
 
Page2 of 3 

  Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __                                                
 
 
 
MM    
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 23_4.1_02212014 
 
Page3 of 3 
 
SC Signature _________________________________________   Date _______________________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 24_Version 4.1_02212014 
 
Page 1 of 3 
 
 
 
 
 
 
 
 
 
Form 24 - COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) 
Circle Visit Below:  
 
Acute Treatment Phase Sessions:  
5 
10 
15 
20 
25 
30 
 
Taper Week:   
 
 
 
1 
2 
3 
 
 
Follow-up Phase Weeks: 
 
 
4 
8 
12 
16 
20 
24 

CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 24_Version 4.1_02212014 
 
 
Page 2 of 3 
 

CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 24_Version 4.1_02212014 
 
 
Page 3 of 3 
 
SC Signature _________________________________________    Date _________________________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
         
MM  
 DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 25_Version 4.1_02212014 
 
Page 1 of 4 
 
Copyright© 1991 by Aaron T. Beck. All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner. 
Form 25- Beck Scale for Suicide Ideation 
 
 
 
Part 
1 
 
 
 
 
 
1 0 
I have a moderate to strong wish to 
live. 
4
0 
I have no desire to kill myself. 
 
1 
I have a weak wish to live. 
 
1 
I have a weak desire to kill myself. 
 
2 
I have no wish to live. 
 
2 
I have a moderate to strong desire to 
kill myself. 
 
 
 
 
 
 
2 0 
I have no wish to die. 
5
0 
I would try to save my life if I found 
myself in a life-threatening situation. 
 
1 
I have a weak wish to die. 
 
1 
I would take a chance on life or death 
if I found myself in a life-threatening 
situation. 
 
2  
I have a moderate to strong wish to 
die. 
 
2 
I would not take the steps necessary 
to avoid death if I found myself in a 
life-threatening situation. 
 
 
 
 
3 0 
My reasons for living outweigh my 
reasons for dying. 
 
 
1 
My reasons for living or dying are 
about equal. 
 
2 
My reasons for dying outweigh my 
reasons for living. 
Circle Visit Below:  
 
Screening 
 
Acute Treatment Phase Sessions: 
5 
10 
15 
20 
25 
30 
 
Taper Week:  
 
 
 
1 
2 
3 
 
 
Follow-up Phase Weeks:  
4
8
12
16 
20 
24

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
         
MM  
 DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 25_Version 4.1_02212014 
 
  
Page 2 of 4 
 
Copyright© 1991 by Aaron T. Beck. All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner.  
 
 
 
 
 
 
 
 
 
 
 
Part 
2 
 
 
 
 
 
6 0 
I have brief periods of thinking about 
killing myself which pass quickly. 
9
0 
I can keep myself from committing 
suicide. 
 
1 
I have periods of thinking about 
killing myself which last for 
moderate amounts of time. 
 
1 
I am unsure that I can keep myself 
from committing suicide. 
 
2 
I have long periods of thinking about 
killing myself. 
 
2 
 I cannot keep myself from 
committing suicide. 
 
 
 
 
 
 
7 0 
I rarely or only occasionally think 
about killing myself. 
10
0 
I would not kill myself because of my 
family, friends, religion, possible 
injury from an unsuccessful attempt, 
etc. 
 
1 
I have frequent thoughts about 
killing myself. 
 
1 
I am somewhat concerned about 
killing myself because of my family, 
friends, religion, possible injury from 
an unsuccessful attempt, etc. 
 
2 
I continuously think about killing 
myself. 
 
2 
I am not or only a little concerned 
about killing myself because of my 
family, friends, religion, possible 
injury from an unsuccessful attempt, 
etc. 
 
 
 
 
 
 
8 0 
I do not accept the idea of killing 
myself. 
11
0 
My reasons for wanting to commit 
suicide are primarily aimed at 
influencing other people, such as 
getting even with people, making 
people happier, making people pay 
attention to me, etc. 
 
1 
I neither accept nor reject the idea of 
killing myself. 
 
1 
My reasons for wanting to commit 
suicide are not only aimed at 
influencing other people, but also 
represent a way of solving my 
problems. 
 
2 
I accept the idea of killing myself. 
 
2 
My reasons for wanting to commit 
suicide are primarily based upon 
escaping from my problems. 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
         
MM  
 DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 25_Version 4.1_02212014 
 
  
Page 3 of 4 
 
Copyright© 1991 by Aaron T. Beck. All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12 0 
I have no specific plan about how to 
kill myself. 
16
0 
I have made no preparations for 
committing suicide. 
 
1 
I have considered ways of killing 
myself, but have not worked out the 
details. 
 
1 
I have made some preparations for 
committing suicide. 
 
2 
I have a specific plan for killing 
myself. 
 
2 
I have almost finished or completed 
my preparations for committing 
suicide. 
 
 
 
 
 
 
13 0 
I do not have access to a method or 
an opportunity to kill myself. 
17
0 
I have not written a suicide note. 
 
1 
The method that I would use for 
committing suicide takes time, and I 
really do not have a good 
opportunity to use this method. 
 
1 
I have thought about writing a 
suicide note or have started to write 
one, but have not completed it. 
 
2 
I have access or anticipate having 
access to the method that I would 
choose for killing myself and also 
have or shall have the opportunity to 
use it. 
 
2 
 I have completed a suicide note. 
 
 
 
 
 
 
14 0 
I do not have the courage or the 
ability to commit suicide. 
18
0 
I have made no arrangements for 
what will happen after I have 
committed suicide. 
 
1 
I am unsure that I have the courage 
or the ability to commit suicide. 
 
1 
I have thought about making some 
arrangements for what will happen 
after I have committed suicide. 
 
2 
I have the courage and the ability to 
commit suicide. 
 
2 
 I have made definite arrangements 
for what will happen after I have 
committed suicide. 
 
 
 
 
 
 
15 0 
I do not expect to make a suicide 
attempt. 
19
0 
I have not hidden any desire to kill 
myself from people. 
 
1 
I am unsure that I shall make a 
suicide attempt. 
 
1 
I have held back telling people about 
wanting to kill myself. 
 
2 
I am sure that I shall make a suicide 
attempt. 
 
2 
I have attempted to hide, conceal, or 
lie about wanting to commit suicide. 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
         
MM  
 DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 25_Version 4.1_02212014 
 
  
Page 4 of 4 
 
Copyright© 1991 by Aaron T. Beck. All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner.  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
20 0 
I have never attempted suicide. 
 
 
 
1 
I have attempted suicide once. 
 
 
 
 
2 
I have attempted suicide two or 
more times 
 
 
 
 
 
 
 
 
 
21 0 
My wish to die during the last 
suicide attempt was low. 
 
 
 
1 
My wish to die during the last 
suicide attempt was moderate. 
 
 
 
 
2 
My wish to die during the last 
suicide attempt was high. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SC ____________________________________________   Date __________________________ 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
                  MM          DD                YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 26_Version 4.1_02212014 
 
Page 1 of 2 
 
Copyright © 1978 by Aaron T. Beck All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner.  
Form 26- Beck Hopelessness Scale 
 
 
 
 
 
 
 
 
1. I look forward to the future with hope and enthusiasm. 
True 
False 
 
2. 
I might as well give up because there is nothing I can do about 
making things better for myself. 
 
True 
False 
 
3. 
When things are going badly, I am helped by knowing that they 
cannot stay that way forever. 
 
True 
False 
 
4. 
I can’t imagine what my life would be like in ten years. 
 
True 
False 
 
5. 
I have enough time to accomplish the things I want to do. 
 
True 
False 
 
6. 
In the future, I expect to succeed in what concerns me most. 
 
True 
False 
 
7. 
My future seems dark to me. 
 
True 
False 
 
8. 
I happen to be particularly lucky, and I expect to get more of the 
good things in life than the average person. 
 
True 
False 
 
9. 
I just can’t get the breaks, and there’s no reason I will in the 
future. 
 
True 
False 
 
10. My past experiences have prepared me well for the future. 
 
True 
False 
 
Circle Visit Below:  
 
Screening 
 
Acute Treatment Phase Sessions: 
5 
10 
15 
20 
25 
30 
 
Taper Week:  
 
 
 
1 
2 
3 
 
 
Follow-up Phase Weeks:  
 
4 
8 
12 
16 
20 
24 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 
MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 26_4.1_02212014 
 
Page 2 of 2 
 
Copyright © 1978 by Aaron T. Beck All right reserved. No part of this publication may be reproduced or transmitted in any form or by any 
means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from the copyright owner. 
11. All I can see ahead of me is unpleasantness rather than 
pleasantness. 
 
True 
False 
 
12. I don’t expect to get what I really want. 
 
True 
False 
 
13. When I look ahead to the future, I expect that I will be happier than 
I am now. 
 
True 
False 
 
14. Things just won’t work out the way I want them to. 
True 
False 
 
15. I have great faith in the future. 
 
True 
False 
 
16. I never get what I want, so it’s foolish to want anything. 
 
True 
False 
 
17. It’s very unlikely that I will get any real satisfaction in the future. 
 
True 
False 
 
18. The future seems vague and uncertain to me. 
 
True 
False 
 
19. I can look forward to more good times than bad times. 
 
True 
False 
 
20. There’s no use in really trying to get anything I want because I 
probably won’t get it. 
True 
False 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature _____________________________   Date ______________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 27_Version 4.1_02212014   
` 
 
 
 
 
 
Page 1 of 3 
 
 
 
 
Circle Visit Below: 
 
 
Baseline                         
End of Active Treatment                 Final Follow-up Visit 
Form 27 – Veterans RAND 36 Item Health Survey (VR-36) 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 27_Version 4.1_02212014 
 
Page 2 of 3 
 
 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM  
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 27_Version 4.1_02212014 
 
Page 3 of 3 
 
SC Signature ________________________________________    Date ______________________________

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __      Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
MM           DD 
           YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
Page 1 of 8 
Form 28 - NEUROPSYCHOLOGICAL BATTERY 
 
 
SELF-RATING SCALE OF MEMORY FUNCTION 
 
Please circle the number that best describes how you feel about each statement. 
 
1.  Compared to before I began to feel bad and had to go to the hospital, my ability to search through 
my mind and recall names of memories I know are there is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
2.  Compared to before I began to feel bad and had to go to the hospital, I think my relatives and 
acquaintances now judge my memory to be: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
3.  Compared to before I began to feel bad and had to go to the hospital, my ability to recall things 
when I really try is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
4.  Compared to before I began to feel bad and had to go to the hospital, my ability to hold in my 
memory things that I have learned is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
Circle Visit Below: 
Baseline  
 
End of Active Treatment 
 
Final Follow up Visit 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 2 of 8 
5.  Compared to before I began to feel bad and had to go to the hospital, if I were asked about it a 
month from now, my ability to remember facts from this form I am filling out would be: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
6.  Compared to before I began to feel bad and had to go to the hospital, the tendency for a past 
memory to be “on the tip of my tongue,” but not available to me is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
7.  Compared to before I began to feel bad and had to go to the hospital, my ability to recall things that 
happened a long time ago is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
8.  Compared to before I began to feel bad and had to go to the hospital, my ability to remember the 
names and faces of people I meet is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
9.  Compared to before I began to feel bad and had to go to the hospital, my ability to remember what I 
was doing after I have taken my mind off it for a few minutes is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
10.  Compared to before I began to feel bad and had to go to the hospital, my ability to remember 
things that have happened more than a year ago is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 3 of 8 
11.  Compared to before I began to feel bad and had to go to the hospital, my ability now to remember 
what I read and what I watch on television is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
12.  Compared to before I began to feel bad and had to go to the hospital, my ability to recall things that 
happened during my childhood is: 
 
13.  Compared to before I began to feel bad and had to go to the hospital, my ability to know when the 
things I am paying attention to are going to stick in my memory is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
14.  Compared to before I began to feel bad and had to go to the hospital, my ability to make sense out 
of what people explain to me is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
15.  Compared to before I began to feel bad and had to go to the hospital, my ability to reach back in 
my memory and recall what happened a few minutes ago is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 4 of 8 
 
16.  Compared to before I began to feel bad and had to go to the hospital, my ability to pay attention to 
what goes on around me is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
17.  Compared to before I began to feel bad and had to go to the hospital, my general alertness to 
things happening around me is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 
18.  Compared to before I began to feel bad and had to go to the hospital, my ability to follow what 
people are saying is: 
-4 
-3 
-2 
-1 
0 
1 
2 
3 
4 
Worse than 
ever before 
 
 
Same as 
before 
 
 
Better than 
before 
 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 5 of 8 
 
DEMOGRAPHIC INFORMATION 
19. Age……………………………………………………………………………….....................___ ___ 
 
20. Dominant hand (Circle One).....................................................................................Right    Left 
 
21. Years of education……………………………………………………………...…................___ ___ 
 
MEDICAL HISTORY  
 
 
 
 
 
 
         
22. Head injury (Circle One)..............................................................................................Yes    No 
If Yes, 
a. enter the date that the event appeared to have begun  ............... __ __/__ __ /__ __ __ __ 
                                                      
 
        
MM            DD                   YYYY 
b. enter the date that the event resolved ......................................... __ __/__ __ /__ __ __ __ 
                                                      
 
 
MM           DD                   YYYY 
c. was there a loss of consciousness? (Circle One) ................................................ Yes    No 
d. If Yes, how long was the loss of consciousness (Circle One Below) 
1 = LOC 0-30 minutes 
2 = LOC more than 30 minutes but less than 24 hours 
3 = LOC more than 24 hours 
 
23. Neurological illness (Circle One).................................................................................Yes    No 
If Yes, 
a. enter the date that the event appeared to have begun  ............... __ __/__ __ /__ __ __ __ 
                                                      
 
            MM           DD                   YYYY 
b. enter the date that the event resolved ......................................... __ __/__ __ /__ __ __ __ 
                                            
 
 
     MM            DD                  YYYY 
 
24. Learning disability (Circle One)...................................................................................Yes    No 
 
25. Substance abuse (Circle One)....................................................................................Yes    No 
If Yes, 
a. enter the date that the event appeared to have begun ................ __ __/__ __ /__ __ __ __ 
                                                      
 
            MM           DD                    YYYY 
b. enter the date that the event resolved ........................................  __ __/__ __ /__ __ __ __ 
                                                      
 
 
 
MM           DD                    YYYY 
 
26. Previous neuropsychological testing (Circle One)......................................................Yes    No 
If Yes, 
a. If yes, enter the date of prior neuropsychological testing ......... __ __/__ __ /__ __ __ __ 
                                                      
 
              MM            DD                  YYYY 
 
27. Any tests familiar to patient (Circle One)....................................................................Yes    No 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 6 of 8 
 
28. Did participant report any significant event that may impact his/her performance on the  
neuropsychological battery? (Circle One)...................................................................Yes    No 
(i.e., recent illness, stressful life event, poor sleep, etc.) 
 
 
RATING SCALES 
Score 
29. Effort Rating………………………………………………………………………………….........____ 
1 = inadequate effort (on one or more tests) 
2 = somewhat inadequate (while patient tries, he/she doesn’t 
really “push” for good performance) 
3 = good performance (patient “pushes” to provide good performance) 
 
30. Anxiety Rating (range 0 – 10) ……………………………………………………….............___ ___ 
 
31. Pain Rating (range 0 – 10) …………………………………………………………..............___ ___ 
 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 7 of 8 
 
 
MEASURES 
MISSING DATA 
RAW SCORE 
COMMENTS 
 
 
Code Accordingly 
32. 
a. RAVLT Trial I 
____ 
____  ____ ____ 
___________________ 
b. RAVLT Trial II 
____ 
____  ____ ____ 
___________________ 
c. RAVLT Trial III 
____ 
____  ____ ____ 
___________________ 
d. RAVLT Trial IV 
____ 
____  ____ ____ 
___________________ 
e. RAVLT Trial V 
____ 
____  ____ ____ 
___________________ 
f. RAVLT Trial B 
____ 
____  ____ ____ 
___________________ 
g. RAVLT Trial VI 
____ 
____  ____ ____ 
___________________ 
h. RAVLT Delayed Recall 
____ 
____  ____ ____ 
___________________ 
i. RAVLT Recognition 
____ 
____  ____ ____ 
___________________ 
j. RAVLT False Positives 
____ 
____  ____ ____ 
___________________ 
k. RAVLT Trial I-V Total 
____ 
____  ____ ____ 
___________________ 
33. SDMT Written Score 
____ 
____  ____ ____ 
___________________ 
 
 
 
/  ____  ____ ____ 
34. 
a. TMT-A Time 
____ 
____  ____ ____ 
___________________ 
b. TMT-A Number of Errors 
____ 
____  ____ ____ 
___________________ 
c. TMT-B Time 
____ 
____  ____ ____ 
___________________ 
d. TMT-B Number of Errors 
____ 
____  ____ ____ 
___________________ 
35. JLO Total Correct 
____ 
____  ____ ____ 
___________________ 
36. 
a. COWAT F Number Correct 
____ 
____  ____ ____ 
___________________ 
b. COWAT F Perseverations 
____ 
____  ____ ____ 
___________________ 
c. COWAT F Intrusions  
____ 
____  ____ ____ 
___________________ 
d. COWAT F Variants 
____ 
____  ____ ____ 
___________________ 
e. COWAT A Number Correct 
____ 
____  ____ ____ 
___________________ 
f. COWAT A Perseverations 
____ 
____  ____ ____ 
___________________ 
g. COWAT A Intrusions  
____ 
____  ____ ____ 
___________________ 
h. COWAT A Variants 
____ 
____  ____ ____ 
___________________ 
 
 

Site __ __     Participant # __ __ __ __ __      Alpha Code # __ __ __ __      Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
  YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 28_Version 4.1_02212014 
 
 
Page 8 of 8 
MEASURES 
MISSING DATA 
RAW SCORE 
COMMENTS 
 
 
Code Accordingly 
i. COWAT S Number Correct 
____ 
____  ____ ____ 
___________________ 
j. COWAT S Perseverations 
____ 
____  ____ ____ 
___________________ 
k. COWAT S Intrusions  
____ 
____  ____ ____ 
___________________ 
l. COWAT S Variants 
____ 
____  ____ ____ 
___________________ 
m. COWAT Total FAS Correct 
____ 
____  ____ ____ 
___________________ 
n. COWAT Total FAS Perseverations 
____ 
____  ____ ____ 
___________________ 
o. COWAT Total FAS Intrusions  
____ 
____  ____ ____ 
___________________ 
p. COWAT Total FAS Variants 
____ 
____  ____ ____ 
___________________ 
q. COWAT Total AN Correct 
____ 
____  ____ ____ 
___________________ 
r. COWAT Total AN Perseverations 
____ 
____  ____ ____ 
___________________ 
s. COWAT Total AN Intrusions  
____ 
____  ____ ____ 
___________________ 
t. COWAT Total AN Variants 
____ 
____  ____ ____ 
___________________ 
37. 
a. Stroop Word Score 
____ 
____  ____ ____ 
___________________ 
b. Stroop Color Score 
____ 
____  ____ ____ 
___________________ 
c. Stroop Color-Word Score  
____ 
____  ____ ____ 
___________________ 
38. NAART Number of Errors 
____ 
____  ____ ____ 
___________________ 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature ____________________________________    Date_______________________ 
CODES:  
U = answer if unknown 
F = rater forgot to obtain data  
L = record of test result was lost 
M = if patient missed appointment 
R = patient refused to provide an answer 
T = patient was not testable or was unable to provide information 
I = invalid data 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
                MM          DD                YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 29_Version 4.1_02212014 
 
Page 1 of 2 
Form 29 – The Drug Abuse Screening Test (DAST) 
 
 
Directions: The following questions concern information about your involvement with drugs. Drug abuse 
refers to (1) the use of prescribed or “over-the-counter” drugs in excess of the directions, and (2) any 
non-medical use of drugs. Consider the past month and carefully read each statement. Then decide 
whether your answer is YES or NO and circle the appropriate answer. Please be sure to answer every 
question. 
 
1. Have you used drugs other than those required for medical reasons? 
Yes 
No 
2. Have you abused prescription drugs? 
Yes 
No 
3. Do you abuse more than one drug at a time? 
Yes 
No 
4. Can you get through the week without using drugs 
(other than those required for medical reasons)? 
Yes 
No 
5. Are you always able to stop using drugs when you want to? 
Yes 
No 
6. Do you abuse drugs on continuous basis? 
Yes 
No 
7. Do you try to limit your drug use to certain situations? 
Yes 
No 
8. Have you had “blackouts” or “flashbacks” as a result of drug use? 
Yes 
No 
9. Do you ever feel bad about your drug abuse? 
Yes 
No 
10. Does your spouse (or parents) ever complain about your involvement 
with drugs? 
Yes 
No 
11. Do your friends or relatives know or suspect you abuse drugs? 
Yes 
No 
12. Has drug abuse ever created problems between you and your spouse? 
Yes 
No 
13. Has any family member ever sought help for problems related to your 
drug use? 
Yes 
No 
14. Have you ever lost friends because of your use of drugs? 
Yes 
No 
Circle Visit Below: 
Screening 
End of Active Treatment 
Final Follow-up Visit 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
                MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 29_Version 4.1_02212014 
 
 
 
Page 2 of 2 
15. Have you ever neglected your family or missed work because of your 
use of drugs? 
Yes 
No 
16. Have you ever been in trouble at work because of drug abuse? 
Yes 
No 
17. Have you ever lost a job because of drug abuse? 
Yes 
No 
18. Have you ever gotten into fights when under the influence of drugs? 
Yes 
No 
19. Have you ever been arrested because of unusual behavior while under 
the influence of drugs? 
Yes 
No 
20. Have you ever been arrested for driving while under the influence of 
drugs? 
Yes 
No 
21. Have you engaged in illegal activities in order to obtain drug? 
Yes 
No 
22. Have you ever been arrested for possession of illegal drugs? 
Yes 
No 
23. Have you ever experienced withdrawal symptoms as a result of heavy 
drug intake? 
Yes 
No 
24. Have you had medical problems as a result of your drug use (e.g., 
memory loss, hepatitis, convulsions, bleeding, etc.)? 
Yes 
No 
25. Have you ever gone to anyone for help for a drug problem? 
Yes 
No 
26. Have you ever been in a hospital for medical problems related to your 
drug use? 
Yes 
No 
27. Have you ever been involved in a treatment program specifically related 
to drug use? 
Yes 
No 
28. Have you been treated as an outpatient for problems related to drug 
abuse? 
Yes 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SC Signature ___________________________________   Date ________________________  

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
 
 
MM 
DD 
YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 30_Version 4.1_02212014 
 
 
Page 1 of 1 
 
 
 
 
SC Signature _____________________________________________     Date __________________________
Circle Visit Below: 
 
Baseline  
End of Active Treatment 
Final Follow-up Visit 
Form 30 – PCL-M

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 
   MM  
   DD 
 YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 31_Version 4.1_02212014 
Page 1 of 2 
Form 31 Michigan Alcohol Screening Test 
 
 
 
 
The following questions concern information about your use of alcohol.  Consider the past month and 
carefully read each question.  Then decide whether your answer is YES or No and circle the 
appropriate answer.  Please be sure to answer every question. 
 
 
1. Do you feel you are a normal drinker?  
Yes 
No 
2. Have you ever awakened the morning after some drinking the night before 
and found that you could not remember a part of the evening before? 
Yes 
No 
3. Does any near relative or close friend ever worry or complain about your 
drinking? 
Yes 
No 
4. Can you stop drinking without difficulty after one or two drinks? 
Yes  
No 
5. Do you ever feel guilty about your drinking? 
Yes 
No 
6. Do friends or relatives think you are a normal drinker? 
Yes 
No 
7. Do you ever try to limit your drinking to certain times of the day or to certain 
places? 
Yes 
No 
8. Are you always able to stop drinking when you want to? 
Yes 
No 
9. Have you ever attended a meeting of Alcoholics Anonymous (AA)? 
Yes 
No 
10. Have you ever gotten into fights when drinking? 
Yes 
No 
11. Has drinking ever created problems between you and a near relative or close 
friend? 
Yes 
No 
12. Has any family member or close friend ever gone to anyone for help about 
your drinking? 
Yes 
No 
13. Have you ever lost friends because of your drinking? 
Yes 
No 
14. Have you ever gotten into trouble at work because of drinking? 
Yes 
No 
15. Have you ever lost a job because of drinking? 
Yes 
No 
Circle Visit Below: 
Screening 
End of Active Treatment 
Final Follow-up Visit 

Site __ __     Participant # __ __ __ __ __    Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                       
 
 
MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 31_Version 4.1_02212014 
 
 
Page 2 of 2 
 
16. Have you ever neglected your obligations, your family, or your work for two or 
more days in a row because you were drinking? 
Yes 
No 
17. Do you ever drink before noon? 
Yes 
No 
18. Have you ever been told you have liver trouble? Cirrhosis? 
Yes 
No 
19. Have you ever had delirium tremens (D.T’s), severe shaking, heard voices or 
seen things that weren’t there after heavy drinking? 
Yes 
No 
20. Have you ever gone to anyone for help about your drinking? 
Yes 
No 
21. Have you ever been in a hospital because of drinking? 
Yes 
No 
22. Have you ever been a patient in a psychiatric hospital or on a psychiatric 
ward of a general hospital where drinking was part of the problem? 
Yes 
No 
23. Have you ever been seen at a psychiatric or mental health clinic, or gone to a 
doctor, social worker, or clergyman for help with an emotional problem in 
which drinking had played a part? 
Yes 
No 
24. Have you been arrested, even for a few hours, because of drunk behavior? 
Yes 
No 
25. Have you ever been arrested for drunk driving or driving after drinking? 
Yes 
No 
 
 
 
 
 
 
 
 
 
 
 
SC Signature ____________________________________  Date _______________________ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __      Date __ __/__ __/__ __ __ __ 
 
 
MM          DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
Page 1 of 6 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
Form 32 – STAXI-2 
 
 
 
 
 
 
 
Gender (Circle One) ............. Male 
Female 
 
1. How I Feel Right Now 
 
1. I am furious 
 
 
 
2. I feel irritated  
 
 
 
3. I feel angry 
 
 
 
4. I feel like yelling at somebody 
 
 
 
5. I feel like breaking things 
 
 
 
6. I am mad 
 
 
 
7. I feel like banging on the table 
 
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Circle Visit Below:  
 
Screening 
 
Acute Treatment Phase Sessions: 
5 
10 
15 
20 
25 
30 
 
Taper Week:  
 
 
 
1 
2 
3 
 
 
Follow-up Phase Weeks:  
 
4 
8 
12 
16 
20 
24 

   
Site __ __     Participant# __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                                    MM         DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
 
Page 2 of 6 
 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
 
8. I feel like hitting someone 
 
 
 
9. I feel like swearing 
 
 
 
10. I feel annoyed 
 
 
 
11. I feel like kicking somebody 
 
 
 
12. I feel like cursing out loud 
 
 
 
13. I feel like screaming 
 
 
 
14. I feel like pounding somebody 
 
 
 
15. I feel like shouting out loud 
 
 
 
 
2. How I Generally Feel 
 
16. I am quick tempered 
 
 
 
17. I have a fiery temper  
 
 
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Not at all 
Somewhat
Moderately so
Very much so
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always

   
Site __ __     Participant# __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                                    MM         DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
 
Page 3 of 6 
 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
 
 
18. I am a hotheaded person 
 
 
 
19. I get angry when I’m slowed down by others’ mistakes 
 
 
 
20. I feel annoyed when I am not given recognition for doing good work 
 
 
 
21. I fly off the handle 
 
 
 
22. When I get mad, I say nasty things 
 
 
 
23. It makes me furious when I am criticized in front of others 
 
 
 
24. When I get frustrated, I feel like hitting someone 
 
 
 
25. I feel infuriated when I do a good job and get a poor evaluation 
 
 
 
 
3. How I Generally React or Behave When Angry or Furious 
 
26. I control my temper 
 
 
 
27. I express my anger 
 
 
 
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always

   
Site __ __     Participant# __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                                    MM         DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
 
Page 4 of 6 
 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
 
28. I take a deep breath and relax 
 
 
 
29. I keep things in 
 
 
 
30. I am patient with others 
 
 
 
31. If someone annoys me, I’m apt to tell him or her how I feel 
 
 
 
32. I try to calm myself as soon as possible 
 
 
 
33. I pout or sulk 
 
 
 
34. I control my urge to express my angry feelings 
 
 
 
35. I lose my temper 
 
 
 
36. I try to simmer down 
 
 
 
37. I withdraw from people 
 
 
 
38. I keep my cool 
 
 
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always

   
Site __ __     Participant# __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                                    MM         DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
 
Page 5 of 6 
 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
 
 
39. I make sarcastic remarks to others 
 
 
 
40. I try to soothe my angry feelings 
 
 
 
41. I boil inside, but I don’t show it 
 
 
 
42. I control my behavior 
 
 
 
43. I do things like slam doors 
 
 
 
44. I endeavor to become calm again 
 
 
 
45. I tend to harbor grudges that I don’t tell anyone about 
 
 
 
46. I can stop myself from losing my temper  
 
 
 
47. I argue with others 
 
 
 
48. I reduce my anger as soon as possible 
 
 
49. I am secretly quite critical of others 
 
 
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always

   
Site __ __     Participant# __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                                    MM         DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 32_Version 4.1_02212014 
 
 
 
Page 6 of 6 
 
Copyright ©1979, 1986, 1988, 1995, 1998, 1999 by Psychological Assessment Resources, Inc (PAR). All right reserved. May not be reproduced in whole or in part in any form or by any 
means without written permission of Psychological Assessment Resources, Inc. 
 
 
50. I try to be tolerant and understanding 
 
 
 
51. I strike out at whatever infuriates me 
 
 
 
52. I do something relaxing to calm down 
 
 
 
53. I am angrier than I am willing to admit 
 
 
 
54. I control my angry feelings 
 
 
 
55. I say nasty things 
 
 
 
56. I try to relax 
 
 
 
57. I’m irritated a great deal more than people are aware of 
 
 
 
 
 
 
 
 
 
SC Signature ________________________________  Date __________________________ 
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always
Almost never 
Sometimes
Often
Almost always

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
                                                            MM           DD               YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 33_Version 4.1_02212014 
 
 
Page 1 of 1 
 
 Form 33 – Urine Toxicology Screen/Alcohol Test  
 
 
 
 
 
 
 
 
 
 
I. Urine Drug Test 
Results 
Dip Card A 
 
 
 
 
1. Methamphetamine (MET) and Ecstasy (ECS) 
 
 
Negative
Positive 
No Result 
2. Amphetamine (AMP) and  
Methylenedioxyamphetamine (MDA) 
 
 
Negative
Positive 
No Result 
3. Marijuana (THC) 
 
 
Negative
Positive 
No Result 
4. Cocaine (COC) 
 
 
Negative
Positive 
No Result 
5. Opiates (OPI)* 
 
 
Negative
Positive 
No Result 
 
 
 
 
 
Dip Card B 
 
 
 
 
1. Barbiturates (BAR)* 
 
 
Negative
Positive 
No Result 
2. Benzodiazepines (BZD)* 
 
 
Negative
Positive 
No Result 
3. Phencyclidine (PCP) 
 
 
Negative
Positive 
No Result 
4. Methadone (MTD)* 
 
 
Negative
Positive 
No Result 
5. Oxycodone (OXY)* 
 
 
Negative
Positive 
No Result 
 
 
 
 
 
II. Alcohol Test 
 
 
 
 
1. Alcohol 
 
 
Negative 
Positive 
No Result 
 
* Opiates, barbiturates, benzodiazepines, methadone, and oxycodone, and THC may be positive if the 
patient is using these medications in accordance with a valid prescription.
Circle Visit Below: 
Screening 
Acute Treatment Phase Blocks:  
2 
4           6 
Taper Phase Week: 
 
 
2 
Follow-up Phase Weeks: 
 
4 
12 
20 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
 
MM 
 DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 34_Version 4.1_02212014 
 
 
 
Page 1 of 1 
 
Form 34 – STUDY COMPLETION / TERMINATION 
 
 
 
 
1.  Did participant complete study? .............................................. No 
Yes 
2. Date of study termination or completion. ................................ Mo__ __ Day__ __ Yr __ __ __ __ 
3. Major reason for not completing study?  ................................. ___ ___ 
01 = Completer - end of study 
02 = Withdrew consent 
03 = Moved 
04 = Unable to return for appointments 
05 = Incarceration 
06 = Lost to follow-up, no response to contacts 
07 = Deceased (Complete Adverse Event form pack)  AE Reference # _____________________ 
 
 
(Date of death)       Mo__ __Day__ __Yr __ __ __ __ 
08 = Intolerance of burden of visits, interviews 
09 = Administrative discharge 
10 = Pregnancy 
11 = Adverse medical event   
 
(Complete Adverse Event form pack)  AE Reference # _________________________ 
12 = Lack of effectiveness 
13 = Other medical illness, specify   
 
14 = Other psychiatric problem, specify   
 
15 = Other, specify   
____________________________________________________________ 
4. Was care transferred to primary Psychiatrist? ........................ No 
Yes 
 
 
4a. If No, why? ________________________________________________________________ 
5. Does the participant believe that the treatment was effective in treating their depression?  
 
(Circle One)  
Not at all  
Slightly  
Moderately  
Considerably  
Extremely
Complete this form when patient completes the study or when it is determined that 
patient will not be returning for study visits. 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __/__ __ __ __ 
 
 
                                           MM          DD               YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 35_Version 4.1_02212014 
 
Page 1 of 1 
 
Form 35 - Control Questionnaire 
 
 
 
 
1.  Please indicate your best guess as to which treatment group the participant was assigned?  
 
 
Real rTMS       Sham 
 
2. How confident are you that your guess is correct? 
 
 
____Extremely        
 
 
____Considerably        
 
 
____Moderately        
 
 
____Slightly        
 
 
____Not at all 
  
 
 
 
 
 
 
 
 
 
 
Signature ________________________________________    Date ________________________ 
Participant completed (SC sign for Participant completed form)
Participant complete: 
Before First Treatment Session 
After First Treatment Session   
End of the Study 
End of the Study completed by: 
Local Site Investigator 
 TMS Treater 
 
  
Study Coordinator 

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
   MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 36_Version_4.1_02212014 
 
 
Page 1 of 2 
 
Form 36 – Protocol Deviation 
 
 
 
 
1. Protocol Deviation ................................. ___ ___ 
 
01 = Adverse Event not reported 
02 = SAE/UADE not reported 
03 = SAE/UADE reported late 
04 = Participant not monitored for AE/SAE/UADE 
05 = Did not follow instructions from IRB or other review bodies/committees 
06 = Confidentiality or privacy breach 
07 = Loss of source documents/samples/source media 
08 = Improper enrollment of a member of a vulnerable population 
09 = Inappropriate participant randomization 
10 = Ineligible participant enrolled 
11 = Pregnancy test not performed prior to enrollment of female participant 
12 = Participant in more than one simultaneous interventional trial 
13 = Inappropriately modified informed consent/HIPAA 
14 = Informed Consent/HIPAA  documentation completed incorrectly 
15 = Informed Consent/HIPAA documentation is incomplete 
16 = Informed Consent/HIPAA not obtained prior to study procedures 
17 = Reconsent/HIPAA reauthorization not obtained in timely manner 
18 = Used incorrect informed consent/HIPAA version 
19 = Drug/Device accountability issue 
20 = Inappropriate intervention unblinding 
21 = Intervention used by non-study individual 
22 = Performed activities not allowed by protocol 
23 = Performed study procedure at incorrect interval 
24 = Required study procedure not performed per protocol 
25 = Study activities performed by inappropriate personnel 
26 = Study intervention not administered per protocol 
27 = Participant non-compliance 
Complete for each protocol deviation 

Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
                                                      
 
   MM  
DD 
YYYY 
 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 36_Version 4.1_02212014 
 
 
Page 2 of 2 
99  =  Other, provide description and reason: ________________________________ 
 
_______________________________________________________________ 
 
2. Date of Deviation: __ __ / __ __ / __ __ __ __ 
 
  MM 
DD 
YYYY 
 
3. Comment:  _______________________________________________________________  
 ________________________________________________________________________  
 ________________________________________________________________________  

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 37A_Version 4.2_02212014 
Page 1 of 2 
VAF 10-61(501)_____ 
09-15-10 
FORM 37A – ADVERSE EVENT (AE) 
FOR COLLECTING ADVERSE EVENTS (AEs) AND ADVERSE DEVICE EVENTS (ADEs) DEFINED IN THE PROTOCOL 
Site Participant # Alpha Code 
Date of Report: (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
1. Adverse Event (s) Being Reported (enter the diagnosis if known; otherwise enter a sign or symptom):
________________________________________________________________________________________
________________________________________________________________________________________ 
2. AE start date/time (record the date/time the AE began)  (mm-dd-yyyy):  ___ ___ - ___ ___ - ___ ___ ___ ___
 Time: _ _: _ _ (military time) (Time field optional)    
 Check if date/time is an estimate. 
3. Following the Adverse Event was the use of the Study Device:
__________________________  
4. If use of the Study Device was Interrupted or Withdrawn, did the Patient Improve?
5. If use of the Study Device was Interrupted or Withdrawn, do you Plan to Restart use of the Device?
6. If Study Device was Restarted, did the AE Reappear?
7. Outcome (check one of the following six possible responses):
 Fatal: date of death (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
 Check if date is an estimate. 
Recovering/ Resolving  (The subject has a good  prognosis and is in the process of recovering or the problem is being 
resolved) Ongoing – create and submit Follow-up in Adverse Event formpack  at least every 30 days until AE is resolved or 
the study ends, whichever occurs first. 
Not Recovered/ Not Resolved (The subject has not recovered yet and the prognosis is unsure or the problem has not 
been  resolved and the resolution is unclear)  Ongoing - create and submit Follow-up in Adverse Event formpack  at least 
every 30 days until AE is resolved or the study ends, whichever occurs first.  
 Recovered/ Resolved (The subject/problem has completely recovered) 
Stop Date: (date/ time the AE ended) (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
Time: __ __: __ __ (military time) (time field is optional)  
 Check if date/time is an estimate. 
Recovered / Resolved with Sequelae (The subject/problem has recovered as much as possible, but is not completely 
resolved) Stop Date: (date/ time the AE ended) (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
Time: __ __: __ __ (military time) (time field is optional)     Check if date/time is an estimate. 
 Unknown 
8. Severity of AE:        Mild    Moderate    Severe 

Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __       Date __ __/__ __ /__ __ __ __ 
 
                                                          MM           DD                YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”   
Form 37A_Version 4.2_10.01.2014 
 
Page 2 of 2 
 
VAF 10-61(501)_____ 
 
 
 
 
 
 
 
 
 
09-15-10 
 
 
9. Is the AE Attributable to the rTMS device?  
 
 
10. Is the AE Attributable to the rTMS treatment?   
 
 
11. Is the AE Attributable to disease progression of depression?   
 
 
12. Is the AE Attributable to medications used to treat depression?   
 
 
13. Is the AE Attributable to Other Patient-Related Conditions?   
  
 
14. Is this event serious? (All seizure and suicide attempts are considered SAE for the purpose of this study. )  
               Yes   If ‘Yes’ complete SAE section of Adverse Event formpack No          
 
  
Comment (optional): 
________________________________________________________________________________________________ 
________________________________________________________________________________________________ 
________________________________________________________________________________________________ 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 37B_Version 4.2_10.01.2014 
Page 1 of 1 
VAF 10-61(501)_____ 
09-15-10
FORM 37B – SERIOUS ADVERSE EVENT (SAE) 
FOR REPORTING ALL SERIOUS ADVERSE EVENTS (SAEs) AND UNANTICIPATED ADVERSE DEVICE EFFECT (UADE). 
ALL SEIZURE AND SUICIDE ATTEMPTS ARE CONSIDERED SAES IN THIS STUDY. 

Site Participant # Alpha Code 
Start Date: (date/ time the SAE began) (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___  
Time: __ __: __ __ (military time) (time field is optional) 
 Check if date/time is an estimate. 
15. Serious Event Type:   Check ALL that apply: Death
  Life-threatening 
  Congenital anomaly/Birth defect 
    Inpatient hospitalization or prolongation of existing hospitalization  
   Persistent or significant disability/Incapacity   
   Any other condition that may jeopardize the subject and require medical or surgical 
treatment to prevent one of the above outcomes 
16. Date Site Investigator became aware of the event: (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___
17. Describe the Serious Adverse Event, including Treatment of the Event: (Describe patient’s condition just prior to, during
and after event – if known give the duration and outcome of this event – DO NOT include past medical history) 
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________ 
18. When did SAE occur relative to randomization?
 Pre-Randomization 
 Post-Randomization 
19. Pertinent Medical History (Include pre-existing medical conditions and adverse events previously reported):
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________ 
20. Concomitant Medications taken at the time of the SAE start date:
1. ___________________________  2. _______________________________  3. ___________________________
4. ___________________________  5. _______________________________  6. ___________________________
7. ___________________________  8. _______________________________  9. ___________________________
21. Pertinent Test Results / Laboratory Data (normal and abnormal) / Date:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________ 
22. Comment:
_______________________________________________________________________________________ 
_________________________________________________________________________________________________ 
_________________________________________________________________________________________________ 
Attach additional pages, if needed. 
 
 
        Page ___ of ___ 
COMPLETE IN ADVERSE EVENT FORMPACK WITHIN 72 HRS 
OF INVESTIGATOR RECEIVING SAE NOTIFICATION

 
 
 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 37C_Version 4.2_10.01.2014 
Page 1 of 3 
VAF 10-61(501)_____ 
09-15-10
FORM 37C – AE/SAE FOLLOW-UP 
Submit at least every 30 days for events that are Recovering/ Resolving or Not Recovered/Not Resolved 
Site Participant # Alpha Code 
1. Date of Follow-up Report (mm-dd-yyyy):  ___ ___ - ___ ___ - ___ ___ ___ ___
2. Indicate whether the diagnosis being reported has changed from the initial AE/SAE report  (e.g., event originally
reported as chest pain, but final diagnosis is MI): 
If yes, indicate the change in the AE/SAE being reported (enter only the diagnosis if known; otherwise enter a sign or symptom. 
Do not enter ‘death’ or ‘hospitalization’ as an event). 
_______________________________________________________________________________________________________ 
_______________________________________________________________________________________________________ 
_______________________________________________________________________________________________________ 
_______________________________________________________________________________________________________ 
3. Has the severity of this AE/SAE changed from the initial report?
If yes, indicate the appropriate severity:        Mild       Moderate      Severe 
4. Has the Serious Classification of the event changed?           Yes
  No 
(All seizure and suicide attempts are considered SAE for the purpose of this study.)
If yes, complete SAE questions below. 
(a) Serious Event Type:      Death               Life-threatening              Congenital anomaly/Birth defect 
 (Mark all that apply)
    Inpatient hospitalization or prolongation of existing hospitalization  
     Persistent or significant disability/Incapacity   
     Any other condition that may jeopardize the subject and require medical or surgical 
treatment  to prevent one of the above outcomes 
(b) Describe the Serious Adverse Event, including Treatment of the Event: (Describe patient’s condition just 
prior to, during and after event – if known give the duration and outcome of this event – DO NOT include past medical history) 
____________________________________________________________________________________________________
____________________________________________________________________________________________________ 
____________________________________________________________________________________________________ 
(c) Pertinent Medical History (Include pre-existing medical conditions and adverse events previously reported): 
____________________________________________________________________________________________________
____________________________________________________________________________________________________ 
____________________________________________________________________________________________________ 
(d) Pertinent Test Results / Laboratory Data (normal and abnormal) 
 Date: (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
____________________________________________________________________________________________________
____________________________________________________________________________________________________ 
____________________________________________________________________________________________________ 

Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
MM          DD                 YYYY
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 37C_Version 4.2_10.01.2014 
Page 2 of 3 
VAF 10-61(501)_____ 
09-15-10
5. Is there additional new information to report?
If yes, please specify: (use this section to provide new information): 
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________ 
6. Is the AE/SAE Attributable to the rTMS device?
7. Is the AE/SAE Attributable to the rTMS treatment?
8. Is the AE/SAE Attributable to disease progression of depression?
9. Is the AE/SAE Attributable to medications used to treat depression?
10. Is the AE/SAE Attributable to other patient-related conditions?
11. Outcome (check one of the following six possible responses):
 Fatal: date of death (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
 Check if date is an estimate. 
Recovering/ Resolving  (The subject has a good  prognosis and is in the process of recovering or the problem is being 
resolved) Ongoing – create and submit Follow-up in Adverse Event formpack  at least every 30 days until AE is resolved or 
the study ends, whichever occurs first. 
Not Recovered/ Not Resolved (The subject has not recovered yet and the prognosis is unsure or the problem has not 
been  resolved and the resolution is unclear)  Ongoing - create and submit Follow-up in Adverse Event formpack  at least 
every 30 days until AE is resolved or the study ends, whichever occurs first.  
 Recovered/ Resolved (The subject/problem has completely recovered) 
Stop Date: (date/ time the AE ended) (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
Time: __ __: __ __ (military time) (time field is optional) 
 Check if date/time is an estimate. 
Recovered / Resolved with Sequelae (The subject/problem has recovered as much as possible, but is not completely 
resolved) Stop Date: (date/ time the AE ended) (mm-dd-yyyy): ___ ___ - ___ ___ - ___ ___ ___ ___ 
Time: __ __: __ __ (military time) (time field is optional)     Check if date/time is an estimate. 
 Unknown 

Site __ __      Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
MM          DD                 YYYY
CS#556 “The Effectiveness of rTMS in Depressed VA Patients” 
Form 37C_Version 4.2_10.01.2014 
Page 3 of 3 
VAF 10-61(501)_____ 
09-15-10
12. Since the last report of this event, was the use of the Study Device:
_________________   
rrupted 
13. If use of the Study Device was Interrupted or Withdrawn, did the patient improve?
14. If use of the Study Device was Interrupted or Withdrawn, do you plan to restart use of the Device?
15. If Study Device was Restarted, did the AE/SAE Reappear?
Comments: _________________________________________________________________________________________________ 
 __________________________________________________________________________________________________________  
 __________________________________________________________________________________________________________  
Attach additional pages, if needed. 
Page ___ of ___ 

VA COOPERATIVE STUDY #556 
The Effectiveness of rTMS in Depressed VA Patients 
Site __ __     Participant # __ __ __ __ __     Alpha Code __ __ __ __     Date __ __/__ __ /__ __ __ __ 
MM  
DD 
 YYYY 
CS#556 “The Effectiveness of rTMS in Depressed VA Patients”  
Form 86_Version 4.1_02212014 
Page 1 of 1 
Form 86 – Informed Consent Confirmation 
 
1.
Did participant sign the Informed Consent Form?
No 
Yes 
If Yes,
a. then provide social security number: __ __ __ - __ __ - __ __ __ __
b. then provide last name __________________________________
2.
Date Consent Signed  __ __/__ __/__ __ __ __
MM  
 DD  
 YYYY 
3.
Patient Consented By: _________________________  Role: ______________
Consent Form Questions 
Please circle the answers to the Consent Form Questions below. 
1)
True
False 
7)
True
False 
2)
True
False 
8)
True
False 
3)
True
False 
9)
True
False 
4)
True
False 
10)
True
False 
5)
True
False 
11)
True
False 
6)
True
False 
COMPLETE AT SCREENING ONLY 

 
 
APPENDIX F 
 
 
Device Handling Procedures 

 
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix F Device Handling Procedures 
 
F-1 
“The Effectiveness of Repetitive Transcranial Magnetic Stimulation 
(rTMS) in Depressed VA Patients” 
 
 
 
DEVICE  
HANDLING PROCEDURES 
 
 
IDE # G100005 
 
Revised May 2012 
 
 
Prepared by: 
THE DEPARTMENT OF VETERANS AFFAIRS 
COOPERATIVE STUDIES PROGRAM CLINICAL RESEARCH PHARMACY 
COORDINATING CENTER (151-I) 
 
 
2401 Centre Ave. SE 
Albuquerque, NM 87106-4180 
 
This document provides general information on investigator responsibilities and details on materials shipped for 
use in this trial. For information on how to use the device, consult the TMS Operator’s Manual. 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix F Device Handling Procedures 
 
F-2 
 
Contents 
1. 
INTRODUCTION AND PURPOSE .............................................................................................................. 3 
2. 
RESPONSIBILITIES OF THE PARTICIPATING INVESTIGATOR ......................................................... 3 
3. 
DESCRIPTION OF CLINICAL TRIAL DEVICES ...................................................................................... 4 
4. 
CLINICAL TRIAL DEVICES AND CLINICAL TRIAL AIDS ................................................................... 4 
5. 
VERIFICATION OF rTMS DEVICE ............................................................................................................ 5 
6. 
REPLACEMENT OF EXPIRED/DAMAGED DEVICES ............................................................................ 5 
7. 
STORAGE REQUIRMENTS ......................................................................................................................... 5 
8. 
REQUIRED DOCUMENTATION ................................................................................................................ 5 
9. 
DEVICE RETURN POLICY.......................................................................................................................... 5 
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix F Device Handling Procedures 
 
F-3 
1. INTRODUCTION AND PURPOSE 
Each site investigator (SI) is responsible for a complete and accurate accounting of all study devices and 
other materials received by the site. The VA Cooperative Studies Program Clinical Research Pharmacy 
Coordinating Center (PCC) in Albuquerque, New Mexico will provide instructions and assistance as 
necessary to assure proper use of and accountability for all study materials. Each site must observe local 
policies and applicable state and federal regulations concerning study devices. 
The device used in this study is the MagPro R30 Magnetic Stimulator, manufactured by Tonica 
Elektronik A/S.  
 
2. RESPONSIBILITIES OF THE PARTICIPATING INVESTIGATOR 
 
The SI at each site is responsible for: 
 
2.1 Providing PCC with the following documents: 
2.1.1 Investigator’s Signed Agreement (ISA): The PCC will provide each SI with a 
partially completed “Investigator’s Signed Agreement” form. This form must be 
completed, signed, and returned to the PCC prior to the shipment of any clinical trial 
devices to your center.  
2.1.2 Curriculum Vitae: A signed and dated copy of the investigator’s updated curriculum 
vitae (CV) must be attached to each “Investigator’s Signed Agreement.” 
2.1.3 Research Committee Approval: A signed letter from the Associate Chief of Staff 
(ACOS) for Research and Development or other authorized individual indicating CSP 
#556 has been approved at your center. The letter must list the name of the SI who is 
responsible for the clinical trial.  A copy of this document must be received before PCC 
will arrange shipment of the clinical trial device to your center.  
2.2 Retaining all study-related documents until notified by the CSP Coordinating Center 
concerning the disposition of the documents. CSP studies remain active for five years after the 
last patient follow-up.  
2.3 The SI, any subinvestigator, and any other personnel associated with the study will not 
represent that device used in CSP #556 is safe or effective for the purpose for which it is being 
investigated. 
2.4 The site investigator will use the investigational device only with subjects under the 
investigator’s personal supervision or under the supervision of a sub investigator listed on the Site 
Investigator’s Agreement (SIA). The investigational device may be used only for the purpose of 
this study.  
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix F Device Handling Procedures 
 
F-4 
3. DESCRIPTION OF CLINICAL TRIAL DEVICES  
3.1 
Clinical Trial Device - The device used in this study is the MagPro R30 Magnetic Stimulator for 
repetitive transcranial magnetic stimulation (rTMS ) in treating Treatment –Resistant Major Depression 
(TRMD). The device is programmed to (a) determine a patient’s motor threshold and (b) deliver active or 
sham magnetic stimulation, depending the participant's treatment assignment. An Operator’s Manual with 
instructions for the use of the MagPro R30 will be sent prior to the first randomization and will be 
available on the study SharePoint site. 
 
 
 
4. CLINICAL TRIAL DEVICES AND CLINICAL TRIAL AIDS 
4.1 RTMS device and associated equipment. Following receipt of all required documentation (Section 
2.1), the PCC will arrange for shipment, installation, and training of the rTMS device by the 
manufacturer.  
4.2 Audiometer. Following receipt of all required documentation the PCC will ship one Earscan 3 
screening audiometer to each site. Each audiometer includes a manual which is also available at 
http://www.earscan.com/earscan3m.aspx. 
4.3 Alcohol and drug test kits. Following receipt of all required documentation and in anticipation of 
imminent randomization, PCC will ship commercially-available drug and alcohol tests to each site.  These 
will be used in participants as specified in the protocol. These tests must be stored at room temperature in 
a locked room. Directions for use are included with each test. To reorder, sites should contact PCC via 
email, fax or phone. 
4.4 Patient ID Cards – PCC will ship patient identification (ID) cards to each site. At the randomization 
visit, this wallet-sized ID card should be filled out and given to the subject with instructions to present the 
card to any clinician seen for medical treatment while participating in CSP #556. If additional Patient ID 
cards are needed, the site coordinator should to contact PCC via email, fax or phone. 
   
CSP 556 Patient ID card 
(Printing on Both Sides of the Card) 
 
 
 
4.5  Electrodes.  Following receipt of all required documentation and in anticipation of imminent 
randomization, PCC will ship two types of electrodes to each site.  Stimulating electrodes will be used to 
mimic the sensation of active TMS.  Recording electrodes will be used to evaluate motor threshold.  See 
Operators Manual for complete information.  If more electrodes are needed, sites should contact PCC by 
email, fax, or phone. 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix F Device Handling Procedures 
 
F-5 
4.6  Ancillary supplies.  PCC will provide all supplies listed on the table below once required 
documentation is received and sites are ready to start the study.  
Supply 
Description of use 
Resupply 
Fabric caps 
Various sizes of fabric caps to be used 
for the correct placement of the rTMS 
coil. 
Contact PCC 
Styrofoam 
sheets 
Boxes of Styrofoam sheets used to 
cushion a patients head from the rTMS 
coil 
Not provided.  If more sheets are 
needed, sites should order using 
their site budget. 
Earphone 
covers 
Disposable covers to place on the 
earphones of the audiometer for each 
patient use 
Contact PCC 
 
 
5. VERIFICATION OF rTMS DEVICE 
 
Each device will be delivered to a site and tested for functionality by the MagVenture technicians. 
Each device will also be verified by PCC Quality Compliance personnel for performance of 
active and sham treatments.  
 
6. REPLACEMENT OF NONFUNCTIONAL/DAMAGED DEVICES 
If a device is damaged or broken, sites should contact the COTR at PCC and the device 
manufacturer to arrange for repair or replacement.  
 
7. STORAGE REQUIRMENTS 
CSP #556 clinical trial devices and ancillary supplies must be kept in a secure, locked area. Each 
rTMS device must be housed in a room that is approximately 8’x15’ and has a dedicated 20 amp 
circuit. 
 
8. REQUIRED DOCUMENTATION 
A complete and accurate record of all clinical trial devices received from PCC is the 
responsibility of the Site Investigator (SI). The SI and Site Coordinator will maintain records to 
meet the requirements of the FDA, VA CSP, and the manufacturer.  
 
9. DEVICE RETURN POLICY 
At the end of the clinical trial PCC will instruct the site as to the disposition of the device.  
 
  

 
APPENDIX G 
 
 
Investigator’s Brochure 
 

 
 

 
Investigator’s Brochure 
 
for 
 
VA Cooperative Studies Program Study, CSP #556 
 
 
“The Effectiveness of Repetitive Transcranial Magnetic Stimulation 
(rTMS) in Depressed VA Patients” 
 
 
 
 
STUDY DEVICE: 
MagPro R30 Magnetic Stimulator 
 
Revised November 30, 2015 
 
 
 
 
Prepared by: 
Department of Veterans Affairs 
Cooperative Studies Program Clinical 
Research Pharmacy Coordinating Center (151-I) 
2401 Centre Ave. SE 
Albuquerque, NM  87106 
 
 
 
 
 
 
 
This section contains information, pertinent to the safety and effectiveness of repetitive transcranial 
stimulation (rTMS). 
 
 
 

 
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
Version 4.6, November 2015 
Appendix G Device Information Report (Investigator’s Brochure) 
 
 
 
 G-1 
 
MagPro R30 Magnetic Stimulator 
 
rTMS stimulates and induces firing in cortical neurons by producing brief pulses of an intense magnetic 
field, which ultimately leads to neuronal summation and depolarization1. At present, the MagPro R30 
device is FDA approved for the stimulation of peripheral nerves and muscles. It has also been studied for 
potential usefulness in treating depression, as is discussed below. 
Summary of Relevant Clinical Studies 
There have been a large number of published trials of rTMS for the treatment of depression 2 3-10  8,11,12 13-
31 32-36 24 28 15 20 14 27,31,37-40. Because small participant pools have been a frequent limitation, several meta-
analyses have been conducted in order to assess the value of rTMS as a treatment for depression, each 
using different base references and statistical methods 33,36,41,42. 
 
In many of the trials evaluated in these meta-analyses, participants had failed prior medication trials. 
Thus, the participants represented in the published literature are, in general, a pre-selected group of more 
difficult to treat patients than those seen in typical studies of new antidepressant medications. Still, the 
conclusion of each of these five published meta-analyses has been the same: daily prefrontal rTMS 
delivered over several weeks has antidepressant effects greater than that obtained with placebo.  
 
In a meta-analysis by Burt et al. of 23 published comparisons for controlled rTMS prefrontal 
antidepressant trials containing both treatment-resistant and non-treatment-resistant subjects, the authors 
found that rTMS had a combined effect size of 0.67, considered to be a moderate to large antidepressant 
effect32. In a sub-analysis, rTMS was compared with ECT. The effect size for rTMS in these studies was 
greater than in the studies comparing rTMS to sham, which may indicate a participant selection bias. The 
authors infer that rTMS may be most effective in the patients who also satisfy clinical predictors for 
positive ECT response.  
 
A meta-analysis conducted using the Cochrane library guidelines was performed using literature 
published prior to 200142. This stringent meta-analysis included 14 trials suitable for analysis and found 
that left prefrontal high-frequency rTMS at two weeks produced significantly greater improvements in the 
Hamilton Rating Scale than did sham treatment.  However, a comparison of rTMS in general (i.e., not 
limited to high-frequency left prefrontal treatment) did not show a statistically significant difference.   
 
A 2008 meta-analysis by Lam and colleagues43 evaluated 24 randomized, sham-controlled studies 
containing 1092 patients with treatment-resistant depression. The analysis found a standardized mean 
difference of 0.48 for rTMS. Active treatment produced a response rate of 25% and remission rate of 9% 
compared to 17% and 6% respectively for placebo.  The effect was robust and very few patients withdrew 
from the trial for adverse effects (2% withdrawal rate for active, 1.5% for placebo).  However, most 
studies evaluated had a short follow-up time of 1-3 weeks, with no studies that evaluated response beyond 
9 weeks. We hope that the current study can answer questions about long-term response. 
 
Side Effects and Complications 
Routine rTMS is usually mildly uncomfortable, but in some cases, particularly when applied over certain 
peripheral or cranial nerves, the treatment can be painful. TMS treatment produces a sensation on the 
head that most patients tolerate without problems. The painfulness is linked to the intensity of stimulation, 
which varies from subject to subject because dosing is based on individual patients’ motor thresholds. 
Thus, some patients with high motor thresholds receive higher dose TMS than do other patients, and there 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
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is a rough correlation of painfulness with intensity of stimulation. The rate of self-reported discomfort is 
generally low and the overall rate of discontinuation of treatment due to pain is estimated at <2%26, 27. 
Further, pain tends to diminish over time, with one study finding a 48% decrease in painfulness from 
baseline over the course of 15 sessions27. 
 
Headache appears to be a common but generally mild side effect of TMS. While pain associated with 
rTMS usually disappears rapidly, muscle headaches may occasionally persist for a few hours after 
stimulation44. These headaches are not severe may respond to treatment with acetaminophen or 
ibuprofen26.  
 
The primary safety concern with rTMS is the risk of seizure induction. Rossi et. al systematically 
reviewed the literature for reports of seizures and found 16 cases.  Of these, seven had occurred prior to 
the establishment of safety guidelines in 1998 and five were associated with rTMS treatment performed 
outside of the currently recommended safety guidelines adhered to in the current trial45. In addition, 
another seizure in a participant who had consumed excessive alcohol the night prior to the event has been 
reported in the medical literature after the publication of Rossi46. 
 
Of the four seizures that appear to have been induced by treatment considered within current safety 
parameters, two may actually represent non-epileptic events. Clinical features of one of these events may 
be more consistent with convulsive syncope; in the other case, lack of response to anti-epileptic drugs and 
a normal neurological exam and EEG indicate that the event may have actually been a pseudoseizure. 
Even if all four events were true seizures, these reported cases have occurred within a sample size of 
thousands. Thus, the risk of seizure in non-epileptic patients is estimated at less than 1%45.  
 
rTMS is generally regarded as safe and without lasting side effects45. There have been no significant 
cognitive 47,48, neurological 49 or cardiovascular sequelae reported as a result of rTMS. Immediately 
following an rTMS session similar to the ones proposed in this protocol, participants tested do not show 
significant neurocognitive side effects. Participants are free to return to work or drive themselves home.  
 
rTMS may produce sounds at >120 dB, a level known to produce hearing loss; thus, hearing protection is 
required for all participants and treaters.  There are a few published accounts of temporary and, in one 
case involving inadequate hearing protection, permanent hearing loss.  One report found that mean group 
threshold at 1 kHz rose from 9.0 to 14.0 dB in five depressed patients treated for six weeks; however, this 
was not statistically significant.  The same study noted measured hearing loss in one patient at 6-8 kHz (15 
dB change) and another patient at 3-4 kHz (20 dB change).  Retesting of the patient with more severe 
hearing loss found that hearing had returned to baseline a month later50. Another study showed slight, 
transient changes in hearing in two normal volunteers51.  Hearing returned to normal within four hours. In 
addition, permanent hearing loss (30 dB at 4 kHz)  has been reported in one individual whose earplugs 
had fallen out during treatment52.   
 
In addition to these case reports, there have been two studies that specifically examine hearing changes in 
patients exposed to rTMS. The first, a study of single pulse rTMS, did not find any hearing loss53.  A 
more recent study of a single session of rTMS with healthy volunteers found that, while there was no 
change in hearing threshold (as measured by pure-tone audiometry), there was a slight temporary 
alteration in transiently evoked otoacoustic emissions, a more sensitive measure of cochlear functioning.  
The effect was significant only in subjects who were least protected by earplugs and persisted for less 
than one hour54. 
 
To date, all reported cases of hearing loss are mild and all but the case involving inadequate auditory 
protection have been transient.   In accordance with the current TMS guidelines45, all participants and 
treaters will wear the provided foam earplugs and over-ear headphones  to minimize potential ear damage 
while maintaining the blind. Also in accordance with these guidelines, the risks of participation to patients 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
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Appendix G Device Information Report (Investigator’s Brochure) 
 
 
 
 G-3 
 
receiving ototoxic medication and those with pre-existing noise-induced hearing loss should be carefully 
considered prior to enrollment in this study.  Patients considered at high risk of further hearing loss may 
be excluded at the clinician’s discretion.  When such patients are included, particular care should be given 
in ensuring that hearing protection is properly placed prior to each treatment. Patients who complain of 
hearing loss, tinnitus, or aural fullness following rTMS treatment should be referred for further 
audiometric testing prior to receiving further stimulation.  
 
There has been one case report of posterior vitreous detachment (PVD) and retinal tear in a 60-year-old 
woman which appears to have occurred during or immediately after the patient’s 11th RTMS treatment for 
depression55. Stimulation for this patient was right-sided and given at 110% of motor threshold for 
periods of 1000 seconds (16.6 minutes).  The patient, who had experience eye twitching and discomfort 
during previous treatment sessions, reported new floaters in her right eye which were determined to be 
related to PVD with a small retinal tear.  The authors of this report hypothesize that the tear may have 
been triggered by the mechanical trauma of rapid contraction of extraocular muscles in response to TMS 
treatment.  The patient was thought to be at increased risk for PVD due to her age and because the 
patient’s motor threshold location resulted in a treatment position closer to her eye than in previous 
treatment sessions. 
 
The stimulation duration in this case was considerably longer than is planned in this trial (3 trains of 1000 
seconds separated by one minute intertrain intervals compared to 4 second trains with 10 second 
intervals); nevertheless, investigators should be aware of the possibility of PVD and retinal tears, 
particularly in patients over age 60.  Excessive activity of the extraocular muscles, beyond the expected 
stimulation of periorbital muscles, should be monitored and the presence of new floaters, flashes of light, 
decreased vision, or eye discomfort following treatment should initiate immediate investigation.  
 
Acute psychiatric changes including treatment-emergent changes have been reported in some patients 
treated with rTMS including cases which occurred in patients without a history of mania or psychosis56. 
However, few cases have been reported and the rate of manic switching is not significantly different 
between active and sham treatment (0.84% and 0.73% respectively)57. 
 
The VA has long been concerned with the issue of suicide in veterans and has funded a special MIRECC 
in VISN 19 to perform research on this issue and with whom this protocol has been developed. A major 
risk in treating seriously depressed patients is the risk of suicide. Even more difficult, many of these 
patients have a background of having made multiple attempts. Thus, monitoring suicide attempts, and less 
serious gestures, is of paramount importance. In the recently completed industry trial suicidal ideation as 
indexed by the HRSD Item 3 on suicidal ideation increased in 3% of sham patients over 6 weeks and did 
not increase in active rTMS patients. The findings of increased suicidal ideation in some sham patients as 
well as the fact that the population of TRMD patients as a whole are at elevated risk for suicide require 
that certain preventive measures be taken (Section X.B.7). Both suicidal ideation (Section VI.G.13) and 
behavior (Section VI.G.18) will be monitored.   
 
In summary, the short-term adverse events expected in this trial are mild discomfort at the site of 
stimulation, transient tension-type headaches on the day of stimulation, and concerns about high-
frequency hearing loss. A risk exists for suicide in these patients, however, extensive precautions have 
been planned in collaboration with experts on suicide from the VISN 19 MIRECC and it is felt that 
inclusion of such patients in this protocol is consistent with providing new treatment options for these 
difficult patients.   
 
Risk Minimization 
 
 
The risks associated with the procedures will be minimized as follows: 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
Version 4.6, November 2015 
Appendix G Device Information Report (Investigator’s Brochure) 
 
 
 
 G-4 
 
1) An independent group of physicians representing the Data Monitoring Committee (DMC) 
will monitor the data.  The DMC will also provide an independent statistical review of the 
data. 
2) All investigators and site personnel will be trained in the use of the device and in the 
protection of human subjects. 
3) Treatments will be conducted as outlined in the protocol, and adverse events will be 
collected and reviewed for patient safety. 
4) Assessments required in the protocol, including substance abuse and suicidality, etc are 
summarized on page 37 of the submitted protocol and discussed in the subsequent pages of 
the protocol. 
5) Suicidality Risk Minimization - A common practice is to stop a treatment if a patient makes a 
suicide attempt. Because this may occur early in treatment, before a patient is adequately 
treated (in the active group), we would elect to continue treatment with the patient in an 
inpatient unit if the patient agrees to continue the trial.  Discharge would be based on the 
patient’s ability to adhere to a modified safety plan (listing behaviors and strategies in the 
event of increasing suicidal impulses, including returning to the ER).  We will develop a 
safety plan agreed upon with the clinician and the patient as a condition of entry into the 
study.  Failure of the patient to comply with the safety plan will require stopping study 
treatments and aggressively treating the suicidality.   
 
As a condition of participation, we will insist that those patients with a history of suicidality 
have all firearms either removed from their residence or placed under lock and key, including 
trigger locks, with guns and ammunition locked separately and the keys given to another 
family member or friend.  Suicide is an impulsive act and since our patients know how to use 
firearms effectively, the decision to make a suicide attempt will more likely be fatal if a 
firearm is available.  Thus, another stopping point will be a violation of the firearms 
agreement and/or the procurement of a new firearm during the study.  
 
Another way we are attempting to decrease the suicide risk to the patient is to enable the 
patient to continue in treatment with his/her outpatient clinician and to continue taking all 
medication except those which would convey an increased risk of seizures (which would 
likely have resulted in the patient’s having been excluded).  Should the patient drop out of 
outpatient treatment or if we receive information from the clinician that the patient is 
imminently suicidal, we will institute appropriate safety measures and discontinue study 
treatments if a major change in medication or treatment is necessary. Similarly, any patient 
who is so imminently suicidal (or homicidal) that he would require involuntary treatment, 
would no longer meet criteria for continuing study treatments.  
 
6) Drug Abuse Risk Minimization - Another stopping point will be the acute abuse of alcohol, 
OTC medication, opiates, or street drugs by the patient.  Under the exclusion criteria, we 
have listed substance abuse within the previous 90 days because evaluating withdrawal 
symptoms or cravings in the context of a depression study complicates the evaluation.  
Furthermore alcohol withdrawal, cocaine and stimulant abuse, and barbiturate withdrawal are 
all associated with an increased risk of seizures.  More critically, actively abusing drugs or 
alcohol is associated with a higher risk of completed suicide.  Thus, beginning to abuse 
alcohol or drugs could well be a prelude to a completed suicide and must be immediately 
addressed. 
List of Contraindicated Drugs 
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Stimulation in Neuropsychiatry. Washington DC: American Psychiatric Press:13-44. 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
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Appendix G Device Information Report (Investigator’s Brochure) 
 
 
 
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2. 
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CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
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Appendix G Device Information Report (Investigator’s Brochure) 
 
 
 
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CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”                                                  
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35. 
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Little JT, Kimbrell TA, Wassermann EM, et al. Cognitive effects of 1- and 20-hertz 
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Nahas Z, DeBrux C, Chandler V, et al. Lack of significant changes on magnetic 
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51. 
Pascual-Leone A, Houser CM, Reese K, et al. Safety of rapid-rate transcranial magnetic 
stimulation in normal volunteers. Electroencephalogr Clin Neurophysiol. Apr 
1993;89(2):120-130. 
52. 
Zangen A, Roth Y, Voller B, Hallett M. Transcranial magnetic stimulation of deep brain 
regions: evidence for efficacy of the H-coil. Clin Neurophysiol. Apr 2005;116(4):775-
779. 
53. 
Pascual-Leone A, Cohen LG, Shotland LI, et al. No evidence of hearing loss in humans 
due to transcranial magnetic stimulation. Neurology. Mar 1992;42(3 Pt 1):647-651. 
54. 
Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation: 
hearing safety considerations. Brain Stimul. Jul 26 2011. 
55. 
Kung S, Ahuja Y, Iezzi R, Sampson SM. Posterior vitreous detachment and retinal tear 
after repetitive transcranial magnetic stimulation. Brain Stimul. Sep 6 2011. 
56. 
Sakkas P, Mihalopoulou P, Mourtzouhou P, et al. Induction of mania by rTMS: report of 
two cases. Eur Psychiatry. Jun 2003;18(4):196-198. 
57. 
Xia G, Gajwani P, Muzina DJ, et al. Treatment-emergent mania in unipolar and bipolar 
depression: focus on repetitive transcranial magnetic stimulation. Int J 
Neuropsychopharmacol. Feb 2008;11(1):119-130. 
 
Contraindicated drugs are listed in Appendix H - List of Exclusionary Drugs 
 
 

Page 1 of 16 
MagVenture rTMS solution 
- for advanced clinical research, requiring double blinded testing.
System Setup 
MagVenture’s rTMS solution includes a complete setup including magnetic stimulator, 
comfortable chair, head rest system, motor threshold determination, head caps, positioning 
/repositioning system, fixation of magnetic coil, sham concept and magnetic coil. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 2 of 16 
MagPro R30
The MagPro R30 is an advanced high performance magnetic stimulator designed primarily for 
clinical use. The stimulator is often used for Transcranial Magnetic Stimulation (TMS) and 
repetitive Transcranial Magnetic Stimulation (rTMS) research. 
With the repetition rate up to 30 pulses per second the MagPro R30 covers most protocol 
settings.
List of Core Specifications and Features 
 Repetition Rate up to 30 pulses per second 
 Pulse width 280Ps with Biphasic Waveform 
 Pulses in Train: 1-1000 
 Number of Trains: 1-500 
 Inter Train Interval: 1-120s 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 3 of 16 
Treatment Chair 
For optimal comfort a chair is part of the solution. 
Possible to adjust seat height and tilting for best possible 
comfort.
Head rest for easy positioning of patient head during treatment. 
Only 85 kg. 
Airpump and Vacuum pillow 
Airpump unit for vacuum pillows for easy support of 
patients head during magnetic stimulation.  
The vacuum pillow consists of an airtight shell 
containing granules of polystyrene. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 4 of 16 
Super Flexible Arm 
The flexible arm is used for easy positioning of the coil. 
The arm has three joints. Two ball joints, of which two can rotate 
in multiple directions and one central joint can rotate in one 
direction. All three joints can be locked and unlocked by a single 
grip on the central handle. This allows a very flexible positioning of 
the coils. 
Trolley 
A Trolley is available to ease the mobility of the MagPro R30 
stimulator.
For installations in countries with  
100-120V mains, the 110V/230V 
Power Supply Option must be used.  
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
Appendix G MVI-Attch-15-Datasheet

Page 5 of 16 
Motor Threshold (MT) 
As an important part of all research and clinical studies the Motor Threshold (MT) level for the 
patient must be determined. 
To determine the motor threshold the C-B60 Coil is used for stimulating the motor cortex and 
the MEP Monitor for measurement of the resulting Motor Evoked Potential.  
C-B60 Coil 
Before performing the research study with the Cool-
B65-A/P Coil the motor threshold for each patient 
must be found. 
For this purpose the C-B60 Coil can be used. 
The magnetic field from this coil is equal to 
the active side of the Cool-B65-A/P Coil. 
Built-in amplitude controls on the coil 
handle. This together with the small 
weight makes it very flexible and 
easy to operate with one hand. 
 Max initial dB/dt: 32 kT/s near 
the coil surface 
 Active pulse width: 280Ps (Biphasic) 
MEP Monitor 
With this 1 channel EMG Amplifier connected to the MagPro it is 
possible to measure the Motor Evoked Potential (MEP) signals. 
With the MEP Monitor it is easy to find the motor threshold level. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
Appendix G MVI-Attch-15-Datasheet

Page 6 of 16 
Positioning / Repositioning concept 
For treatment of depression with rTMS the stimulation is applied over the dorsolateral prefrontal 
cortex (DLPFC). The treatment sessions normally takes 30-40 minutes and is repeated 10-20 
times for each patient with one session per day. 
Target: DLPFC-Brodman area 
 
Location of Cool-B65 A/P coil 
MagVentures solution is a simple, rugged, cost effective and easy to use design. 
 Fixation of the coil during treatment with use of a strong and flexible arm. 
 Determination of DLPFC area during motor threshold measurement based on “5 cm” rule. 
Possibility to use 4.5 cm, 5.5 cm and 6 cm steps too depending of patient head size. 
 Simple, fast and easy to operate. Operational by nursing staff. 
 Use of personal cap for each patient. Caps in different sizes to fit different head sizes. 
 Cost effective solution compared to real navigation systems. 
 Adjustable chair for optimal comfort of patient during treatment. 
 Use of vacuum pillow to fixate the patients head. 
 Complete system and chair are mobile and possible to move around. Low weight compared 
to systems with special “dental” chair and big navigation system.  
 Coil positioning/repositioning within ±10mm accuracy possible.
Head caps 
Textile head caps available in different sizes to fit different head sizes. 
One head cap is selected for each patient. 
The head cap will be used during the motor threshold determination and 
marking of the treatment spot. 
Motor
BA
BA
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
Appendix G MVI-Attch-15-Datasheet

Page 7 of 16 
Procedure for marking of the treatment spot during Motor Threshold determination 
During the Motor Threshold determination the later treatment spot (5 cm rule) is marked on the 
head cap by use of a coil C-B60 with special marking plate. 
For positioning the coil on the head of the patient a bathing cap made of silicone is used. The 
cap has fixation mark on the front which is placed in line with the nasion. The cap is wrapped 
back on the head of the patient and it is secured that the cap is tight on to the front of the skull. 
The cap has a fold in the centre from front to back. This fold must follow the patient heads 
centerline.
The distance from the edge of the cap in front to the nasion is measured and documented for 
the patient. A good idea is to write the distance on the cap on the front. This distance must be 
controlled at each session for the patient for right location of cap. 
Procedure:
 The patient is placed in the treatment chair 
 The patients head size is measured or estimated in order to select a proper head cap size 
 The head cap is mounted on the patient 
 Check that the centerline on the cap is in line with the patients head 
 The distance from nasion to the head cap is measured and noted. Use of glasses can help 
measure this distance for untrained users. A good idea is to write the distance on the cap on 
the front. This distance must be controlled at each session for the patient for right location of 
cap.
 The motor threshold point and MT level is now to be found by using a C-B60 coil with the 
special marking plate mounted upon it. A MEP-unit can optionally be used to monitor EMG-
activity on APB. Make sure the coil is rotated in a 45° angle to the centerline of the head. 
 The MT stimulation level is noted 
 Using the marking plate on the C-B60 coil the stimulation point is marked with a thin felt tip 
pen.
 This marking will be used to positioning and repositioning the Cool-B65 A/P coil during 
following treatments.  
Measurement of distance to nasion 
 
Marking of treatment spot
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 8 of 16 
Coil C-B60 with marking plate
The marking plate is mounted on the C-B60 coil in an angle of 45° to the centerline on the top of 
the head.
45° line on the marking plate which 
must be parallel to the fold on the 
cap (head centerline). 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 9 of 16 
Cool-B65-A/P Coil
The Cool-B65-A/P Coil is especially designed for advanced clinical studies where double 
blinded research experiments are required. The Cool-B65-A/P is capable to be used both as an 
active (A) coil and as a placebo (P) coil, without operator or patient knowledge. 
The Cool-B65-A/P Coil is based on the Cool-B65 Coil. The Cool-B65 Coil has been on the 
market for more than 4 years and is used for many applications requiring a high number of 
stimuli, e.g. Treatment of Depression. 
Cool-B65 
   
 
Cool-B65-A/P 
                         
 The Cool-B65-A/P has a symmetrical mechanical design and no labeling on the coil 
indicating the active or placebo side. With this setup it is not possible for the operator to see 
or hear which side is used. 
 Built-in orientation switch, used for the software to determine which side the operator shall 
use
 Output for current stimulation surface electrodes 
 Max initial dB/dt: 32 kT/s near the coil surface on the active side, same as Cool-B65 Coil. 
 The magnetic field near the coil surface on the placebo side is <5% of active side 
 Active pulse width: 280Ps (Biphasic) 
 Protocol: 2pps Setup: Output=100%:   
 
Number of stimulations before warm-up: > 20,000 pulses 
 Typical Protocol: 60 trains @ 50 pulses/train @ 10pps @ Inter Train Interval: 25s @ 
Output=120% of MT. 
Performance: Number of stimulations before warm-up: > 10,000 pulses (i.e. more than 3 
patients on a row). 
 Larger ergonomic handle 
 All cables and cooling tubes combined in one cable 
Placebo side (B)
with magnetic field damping
Active side (A)
with maximum magnetic field
Orientation
switch
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
Appendix G MVI-Attch-15-Datasheet

Page 10 of 16 
Lifetime
Due to mechanical, magnetically and thermal 
stress on the coil-winding inside the Cool-B65-A/P 
Coil, the lifetime of the coil is limited. 
The lifetime is defined as maximum 5 years or 
Equivalent Pulse Value (EPV) of maximum 
18.000.000 stimulations whichever occurs first. 
When the coil reach the limit it will stop working 
and it has to be replaced with a new coil. The coil is 
handled as “electronic waste” and is not 
serviceable when it has reached the limit.  
The EPV value is dependent on stimulation current 
waveform and amplitude. See example below. 
Running a protocol of 3000 pulses at 75% MagPro indicated output power, using standard 
biphasic pulses: 
The EPV is 4, and the 3000 pulses is equivalent to 12.000 EPV’s. Providing a lifetime of 
4.500.000 stimuli corresponding to 1.500 run of the protocol ! 
Benefits with Cool-B65-A/P for placebo studies
 It is possible with same coil to perform active stimulation and placebo stimulation 
 No change in mechanical design and weight from side to side 
 No change in sound level during stimulation in active and placebo mode 
 Heating up of the coil is the same in active and placebo mode 
 No labeling on the coil telling which is active side and which is placebo side 
 Output current stimulator for surface electrodes on the patient for sensory sham 
External Cooler Unit 
 The Cool-B65-A/P is connected to an external Cooler 
Unit for circulation of liquid fluid as cooling media. 
 Low noise system with very high performance. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 11 of 16 
Sham Noise Generator 
The sound level from the coil during active stimulation and 
placebo is the same. But to sham the noise during the operation 
100%, both patient and operator are connected to the Sham 
Noise Generator. 
Headsets on both patient and operator are connected to the 
Sham Noise Generator. When a magnetic stimulation pulse is 
fired; a pulse of sham noise is send into the ears. This sham 
noise pulse will hide the click noise from the coil for the patient 
and operator; even at 100% stimulus intensity.
Use your ipod, and connect it to the Sham Noise Generator to 
make the patient feel comfortable with music during the 
treatment.
Earphone Headset 
With the Sham Noise Generator it is possible to adjust the sound volume of the white noise and 
the duration of the pulse.
Two options are available in between Sham noise: Silence or music. 
100msec 
25 sec
Protocol 
25 sec
Pulsed noise 
25 s
Continuous noise 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 12 of 16 
Constant Current Stimulation of skin 
The Cool-B65-A/P Coil has a current stimulation outlet for surface 
electrodes. With this setup it is possible to place electrodes on the 
patient skin beneath the magnetic stimulation coil.  
A current stimulation 
pulse will be sent to the 
electrodes synchronous 
with the magnetic 
stimulation, giving a 
sensory feeling in the skin 
for the patient, again to 
sham the use of placebo 
side or active side.   
Procedure for treatment sessions 
 The patient is placed in the treatment chair 
 The treatment program is loaded into the MagPro
 Surface electrodes (2) are placed on the patient’s left forehead above the eyebrows  
 The patients dedicated treatment cap is placed symmetrically on the head.  
 The patient is now to be rested in the treatment chair. 
 The patient takes on the headset from the sham noise generator 
 The patients head and neck is now fixed by positioning and activating the vacuum pillow.
 The Cool-B65 A/P-coil must turn right according to the instructions indicated on the display 
either: ”Coil Ready” or ”Flip coil” 
 The Cool-B65 A/P-coil is now positioned by adjusting the mechanical arm to the marking on 
the cap.
 The stimulation level is adjusted as prescribed in the treatment protocol 
 The stimulation sequence can now begin, 
and the operator should regularly visual 
control that the stimulation point is 
maintained.
 After treatment session the MagPro is 
disabled and Exit is pressed 
 The coil is removed from the head and the 
cap can be removed from the head and 
stored until the next treatment.  
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 13 of 16 
Setting up double blinded studies 
For clinical research, double blinded studies are often required to verify the efficacy of the 
selected methods and protocols. Since magnetic stimulation is a technique, producing a 
remarkably sound, vibration and sensation, blinding of the patient and the person administering 
the treatment is difficult. The rTMS solution from MagVenture offers a variety of means to 
accomplish the blinding: 
“Blinding” of the patient…
It is a preferred method to adjust the amplitude of the magnetic field, used for rTMS, in a fixed 
relation to the motor threshold (MT) of the individual patient. Finding the MT is well described in 
the literature, and can easily be done by the use of e.g. the C-B60 coil shown above. If required, 
connect the APB to the input of the build-in EMG-amplifier (MEP-unit) to identify the response. 
Then slowly turn up the amplitude of the MagPro to find the threshold.  
Finding the individual MT is associated with a distinct sensation with the patient.  
Thus, continuing with providing a treatment or sham immediately after finding the MT might lead 
to some discussion with the patient as to whether or not the treatment is “felt at all”. And in this 
way there is a risk of jeopardizing the actual “blinding” of the experiment. However, if the MT is 
established in a separate session, this discussion can be somewhat attenuated.
In order not to damage the patients hearing, the patient should wear some means of ear 
protection during the treatment. To blind the patient to the acoustic click noise originating from 
the stimulus, we encourage the use of “sham noise”. The “Sham Noise Generator” shown above 
generates a short pulse of white noise every time a stimulus is provided, thus masking the click 
noise from the coil. This amazing effect is very effective and masks the clicking sound all the 
way up to a 100% stimulator output.  
The sound and the sound level from the A/P-coil during Active-stimulation or Sham-stimulation 
is the same.  
The magnetic field originating from the stimulation coil stimulates a mild skin sensation when 
passing from the coil winding in to the brain. When using sham stimulation this effect is not 
present: To blind the patient to the sensation, a current stimulator is build in to the handle of the 
A/P-coil, and surface electrodes are placed just below the stimulation coil. For every magnetic 
stimulus a synchronous current stimulus is provided inducing an equivalent skin sensation. The 
current stimulator should be used both when using sham and active stimuli to insure blinding of 
the operator. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 14 of 16 
“Blinding” of the Operator…. 
We encourage the use of the multifunctional liquid cooled A/P coil. As described above, the A/P 
coil provides Active or Placebo stimulation, depending on which side is turned up/down. The coil 
winding is placed near one side and turning this side against the patient induces active 
stimulation. In the opposing end of the coil housing a shielding system is integrated to attenuate 
the field and also to balance the weight of the coil. When the coil is flipped 180 degrees, the 
distance from the coil winding to the patients head is much increased. The resulting remaining 
magnetic field is attenuated by the shield, and less than 10% of the active field is left in the 
Sham position.
The encapsulation of the A/P-coil is completely symmetrical, with no markers revealing which 
side is active and which is sham.
The A/P coil is equipped with a small orientation-sensing device. This device reports to MagPro 
which side of the coil is turned towards the patient, and in this way MagPro can detect if active 
or sham treatment is taking place. 
It is not possible to start the treatment before the correct coil is inserted and the correct side is 
turned towards the patient. The MagPro will display the messages “Incorrect Coil” and “Flip Coil” 
if the actual setup does not match the specified setup stored.
When the coil is in-
place, the MagPro is 
enabled and the 
amplitude adjusted to 
the agreed 
amplitude. Pressing 
the Start button will 
initialize the full 
sequence. When the 
treatment is ended 
successfully (or 
interrupted for some 
reason), a line with 
treatment information 
is stored.
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 15 of 16 
Controlling studies 
When a clinical research project has been approved by local IRB’s and the FDA the basic 
protocol parameters intended to be used in the study are usually fixed. From a device-point of 
view, this includes the magnetic pulse treatment parameters like number of pulse trains, total of 
number pulses, repetition rate, inter train interval, theta-burst pulse setup and relation to 
individual Motor Threshold. In some cases, also a specification of the type, form and size of coil. 
Often a wide range of requirements must 
be fulfilled before a patient meets the pre-
inclusion criteria’s for the rTMS-study. 
Patients meeting such criteria’s are 
usually referred to additional screening 
tests, and then it must be decided by the 
study-master if this patient should have 
sham or active treatment.   
MagVenture offers a Program to control 
and configure the treatment and analyze 
the results. This program runs on a 
standard PC and allows the study-master 
to configure individual patients. On the 
first page (see right), the patient data are 
entered and it is selected if the treatment 
should be active or sham.
On the tab “Treatment Data” the basic 
settings are made (rep.rate coil type etc.). 
These settings are most likely to be 
identical for the full study and they are 
therefore saved after the first definition. 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
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Page 16 of 16 
The tab “Results” is used by the study-master for analysis. Every line represents a session and
clearly identifies the used settings, the amplitude, coil data and the number of stimuli 
provided.
At the Results tab a trace of every session is made. One line is added to the results file every
time the treatment is ended or if the timing is for some reason interrupted.
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients”
Version 3.1, April 2013
Appendix G MVI-Attch-15-Datasheet

 
 
 
 
APPENDIX H 
 
 
LIST OF EXCLUSIONARY DRUGS 

 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0 September 2013 
Appendix H, List of Exclusionary Drugs 
H-1 
 
 
This list of exclusionary drugs shall be reviewed and updated as needed and at least annually 
based on new information such as new marketed drugs. Citations are available upon request. 
Amoxapine  
Bupropion (at doses >300mg/day) 
Clomipramine   
Clozapine  
Dantrolene  
Disulfiram  
Flumazenil  
Gingko Biloba  
Ginseng  
Haloperidol  
Illicit Drugs  
 
Heroin 
 
Ecstasy 
 
LSD 
 
Other illicit drugs 
Isoniazid  
Ketamine  
Levodopa  
Lidocaine and other local anesthetics  
Loxapine  
Maprotiline  
Mefenamic acid (>1000mg)  
Meperidine  
Nelarabine  
Olanzapine  
Phenothiazines  
 
Chlorpromazine  
 
Fluphenazine 
 
Perphenazine 
 
Prochlorperazine 
 
Promethazine 
 
Thioridazine 
 
Trifluoperazine 
Piroxicam (> 20mg) 
Stimulants 
 
Amphetamine 
 
Armodafinil 
 
Benzphetamine 
 
Cocaine 
 
Dexmethylphenidate 
 
Dextroamphetamine 
 
Diethylpropion 
 
Ephedra /Ephedrine containing herbal products  
 
Lisdesamfetamine  

 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0 September 2013 
Appendix H, List of Exclusionary Drugs 
H-2 
 
 
 
Methylphenidate 
 
Methamphetamine 
 
Modafinil 
 
Phendimetrazine  
 
Phencyclidine (PCP)  
 
Phentermine 
 
Phenylpropanolamine  
 
 
Pseudoephedrine 
St John’s Wort  
Theophylline  
Tiagabine  
Tramadol  
Vincristine  
 
 
 

 
 
APPENDIX I 
 
 
SEIZURE PROTOCOL AND FOLLOW-UP 
 
 

_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013  
Appendix I, Seizure Protocol and Follow-Up 
I-1 
Seizure Protocol and Follow-Up Procedures 
 
Managing emergencies (syncope and seizures) 
 
First: Stop the TMS session and remove the coil 
 
Each TMS laboratory must institute an explicit plan for dealing with syncope and 
seizures, and every member of the TMS team must be familiar with it. There must be a 
place where the subject can lie down. All team members must be familiar with the means 
of summoning emergency medical help and when to call for it. Additionally, in 
laboratories performing rTMS at >1Hz, life-support equipment should be available.  
 
 
Syncope usually is very brief. Seizures potentially induced by TMS, as well as seizures 
in general, are also brief (typically < 60 s) and without serious physical sequelae. Thus, 
efforts should be focused on preventing complications of the seizure or syncope rather 
than starting any specific medication, which is not required unless status epilepticus 
(which has been never described following rTMS) occurs. In most cases it is enough to 
lay the subject down. Supine position with the legs elevated is appropriate for suspected 
syncope. In case of seizures, attention must be taken to minimize the risk of aspiration 
and left lateral decubitus position is desirable. The description of additional medical 
emergency procedures to treat seizure complications go beyond the scope of the current 
guidelines.   
 
 
Subjects who experience seizures with rTMS should be informed of the fact that they are 
not at a greater risk for further seizures than before. For some individuals, however, the 
potential psychological effects of having had a seizure can be significant and should not 
be ignored or minimized. Informed consent documents discuss the possibility of a 
seizure, and investigators must ensure that the subjects understand its implications. Both 
medical and psychological support must be provided to patients and normal subjects who 
have rTMS-induced seizures.  
 
It is possible that the report of a seizure in a patient’s medical record could be 
misinterpreted or used as a pretext for the denial of employment or medical insurance. 
Subjects of research studies should be informed of this possibility, and investigators must 
make certain that documentation of seizures is done in such a way that jeopardizes 
subjects to the minimum extent possible. Additional documentary support of a healthy 
subject’s claim that a provoked seizure carries no adverse prognosis must be provided 
when appropriate.  
 
Protocol for seizures 
 
All personnel conducting TMS studies must be familiar with the Lab Policy for a seizure.  
 
Responding to a seizure- 
Sample protocol (UC Irvine protocol, courtesy, Steve Cramer, MD) 

_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013  
Appendix I, Seizure Protocol and Follow-Up 
I-2 
• If alone, call for help— 
• If two people are present, the first stays with the subject and the second should go to get 
a nurse, who will call 911 
• Immediately page MD if not physically present 
• Remove harmful objects from the person’s surrounding area 
• If the person is in a chair, gently pull chair back away from metal instruments 
• Loosen tight clothing from around the neck 
• Cushion the head as much as possible 
• Do NOT place fingers or any other objects in or near the person’s mouth 
• Do not attempt to hold the person down 
• Remain calm, seizures almost always stop after a few minutes 
• Observe what is happening, how long, etc—this can help the person later 
• If a person is having trouble breathing, turn them on their side, provide oxygen mask 
• After a seizure, stay with the person until paramedics arrive 
• If there is concern for injury, do not move the person 
 
Safety Equipment 
Basic BLS supplies 
Oxygen 
Face masks 
Crash cart-with medications readily available 
 
Follow-up seizures 
After a patient has been stabilized from a seizure during a TMS treatment, a neurologist 
will need to be contacted immediately, and the patient will be seen by a neurologist as 
soon as possible. Additionally, patients will have the following blood chemistries drawn 
as ordered by the MD. 
 
Full metabolic screen (CBC, serum electrolytes including calcium and potassium) 
 
Serum prolactin level, with the time noted when the serum was drawn relative to the 
seizure (that is, how many minutes or hours after the seizure was the sample drawn). 
 
A urine sample should be collected and sent for a urine drug screen 
 
The neurologist will likely schedule the patient for a brain scan (MRI or CT) and an 
EEG. 
 
The above workup may provide an understanding of precipitating factors involved in the 
seizure, and whether follow-up care is needed. 

_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013  
Appendix I, Seizure Protocol and Follow-Up 
I-3 
 
If the workup is unrevealing, then it would be assumed that this was a TMS induced 
seizure with no sequelae, and a letter can be sent to the patient as in the Appendix. 
 
If at any point during study participation, a participant has a seizure (not including 
syncope), that participant will be withdrawn from study treatments immediately 
(they will still be followed for protocol assessments).  All seizures (not including 
syncope) will be considered serious adverse events and as such, will be reported using 
Form 37 Adverse Event in SharePoint and IRB Form 119 Report of Serious Adverse 
Events and Unanticipated Problems to the VA Central IRB using its website for the 
most-recent version:  
http://www.research.va.gov/vacentralirb/forms/investigator-forms.cfm  
 
 
What follows is a proposed letter to patient regarding seizure from the rTMS study. 

_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013  
Appendix I, Seizure Protocol and Follow-Up 
I-4 
Attachment: Letter to patients regarding seizure 
 
Dear  (patient’s name) 
On ____(date) you experienced a seizure after you were given a study treatment of repeated 
transcranial magnetic stimulation (rTMS) as part of  CSP #556, “The Effectiveness of rTMS 
in Depressed VA Patients”.  This letter is provided to explain the seizure occurrence to you 
and other health care providers.   
Although seizures are rare when patients receive rTMS, they may occur.  We assure you that 
this seizure probably occurred as result of the experimental treatment and does not indicate 
that you have any disease or other health or physical problem.   
Please contact us at _____________ if you have any further questions regarding this event. 
  
  

 
 
 
Appendix J 
 
Removed 
 

 
 
 
 
 
APPENDIX K 
 
 
rTMS TREATMENT REGIMEN  

 
 

 
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APPENDIX K:   rTMS TREATMENT REGIMEN   
This appendix contains the procedure for the administration of rTMS treatment, 
including subject preparation, determination of motor threshold, and the actual 
administration of the stimulus. Additional information on the rTMS device, coils, chair; 
and equipment; cap marking system; rTMS Research Software; MEP Monitor; and 
Sham Noise Generator; can be found in the manufacturer’s datasheets. See 
Appendix G Device Information. 
1. 
Procedures Prior to Treatment Administration 
There will be a number of procedures that will occur prior to treatment: 
 The patient will be asked to remove glasses, earrings or any jewelry 
around the neck. 
 The patient will remove wallets from their pockets if they contain 
magnetic media (e.g., credit cards).   
 The patient will empty their bladder to avoid treatment interruption.  
 The patient will be provided with ear protection. 
 It will be necessary to determine motor threshold for each patient before 
starting the course of treatment: 
o The SI will locate and determine the Motor Threshold (MT) as 
part of the Screening Phase.  The marking cap system is used 
for repeatability of the coil placement. 
o On the first day prior to the first treatment, the administrator will 
determine the MT.  The actual “hands on” procedures will be 

 
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standardized by training provided to each administrator prior to 
the start of the study.  
o In addition to the initial determination of MT, it will also be 
determined at the first session of each 5-session block and of 
each taper treatment block.   
2. 
 Motor Threshold location and determination 
To determine the necessary level of power that must be used, the establishment of a 
“motor threshold” (MT) is the most commonly employed technique (Kiers et al. 1993; 
Pridmore et al.1998).  The MT is usually defined as the minimum amount of electricity 
needed to produce movement in the contralateral thumb, when the coil is placed in 
the appropriate spot over the primary motor cortex (Pascual-Leone et al. 1993).  The 
MT determining method has been improved with the use of an electromyograph 
(EMG) that is easier to teach, train, and operationalize than the visual method. In the 
recently completed NIH TMS trial, 3 of 4 sites used the EMG method, while one site 
used visual movement. The TMS vendor has incorporated a sophisticated EMG 
system within the TMS device and will provide the necessary software. A procedure 
called Maximum-Likelihood Strategy using Parameter Estimation by Sequential 
Testing MLS-PEST is a mathematical algorithm that is a promising alternative to 
traditional, time-consuming methods for determining MT. Because the EMG-PEST 
method is totally automated, it may prove useful in studies using MT as a quickly 
changing variable, as well as in large-scale clinical trials (Mishory et al. 2004). Dr. 
George’s Brain Stimulation Lab has developed simple algorithms to use with the 
EMG system that can make MT determination rather rapid (8 pulses) and highly 
reproducible, essentially reducing and eliminating operator error, and almost like an 
automatic blood pressure cuff. 
 
MT will be determined using Motor Evoked Potential (MEP) and the Parametric 
Estimation by Sequential Testing (PEST) procedure along with the CB60 coil. Refer 
to the MEP Monitor Use Guide in Appendix G Device Information.  

 
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3. 
Treatment Administration 
Treatment will be administered following these procedures: 
 A qualified registered nurse, nurse practitioner, or physician assistant 
will administer the treatment as well as determine all MT’s, except for 
the one done at screening.   
 The treatment administrator and all study personnel will be masked to 
the treatment.   
 All treatments will be conducted in a business-like manner minimizing 
personal contact with the patient.   
 The Cool-B65 A/P coil is used for treatments. 
 The treatment location will be 6 cm anterior (i.e., forward) to the hand 
motor area stimulation point identified above, on a para-sagittal line, 
using the marking cap procedure. 
 The rTMS device utilized will have a rigid arm-holder for positioning the 
rTMS coil on the person’s head, and a head-holding system to maintain 
consistent and reproducible head orientation through the multiple 
treatment sessions. 
 The rTMS treatment and sham group will receive the following dose of 
rTMS delivered over the left prefrontal cortex:  
o Power: 120% of motor threshold as separately determined for 
each participant prior to treatment/placebo sessions. 
o Pulse frequency: 10 Hz 
o Length of each pulse train: 4 seconds 
o Time between pulse trains: 10 seconds 

 
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o Length of treatment: 25 minutes 
o Units of 5 sessions will be delivered over one week’s time.  
These units of 5 sessions can be delivered over a minimum of 5 
calendar days and a maximum of 12 calendar days.   
o Patients will receive a minimum of 20 sessions of treatment and 
a maximum of 30 sessions.  This will total 4000 pulses per 
session or 80,000 pulses for 20 sessions or 120,000 pulses for 
total 30 sessions, respectively.  
o For those individuals not showing clinical response, they will 
continue getting their initial treatment (sham or active) up to 30 
sessions maximum.  
o Although the treatment will be administered at 120% MT, at the 
beginning of each treatment session, and after a treatment 
pause, there will be a ‘ramp up’ beginning at 80% of the 
therapeutic dose and increasing by 5% with each pulse train to 
facilitate comfort of the subject.  The treatment will require one 
25 minute session per day.  
4. 
Monitoring for Adverse Events 
 Possible Seizure Activity. 
o During the treatment procedure, the treatment administrator 
must observe the patient closely for any sign of imminent seizure 
activity or muscle twitching.  The administrator must be an 
individual trained to be perceptive to warning signs, and familiar 
with the emergency management of seizure activity.  Emergency 
equipment (oxygen, suction, CPR equipment) must be readily 
available for the treatment suite. 
 

 
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 Other Adverse Events. 
o During the treatment procedure, the administrator will assess for 
and record any adverse events.   
o Prior to leaving the facility following each treatment, the patient 
will be assessed for the occurrence of adverse events by a 
qualified individual who is masked to the subject’s assigned 
treatment group.  
o Patient should be routinely queried at each visit as to whether 
they have experienced any adverse events. Reports of 
significant, possible related adverse events such as changes in 
hearing or vision should prompt adverse event reporting and 
further evaluation to ensure that no patient is placed at excessive 
risk. 
5. 
Interruptions 
Every attempt shall be made to complete each treatment session as per the protocol.  
Interruptions during the treatment are allowed as needed for patient comfort or 
convenience by using the “pause” selection on the device.  However, in the event 
that an incomplete treatment is given, this information will be recorded.  Total number 
of treatments will be recorded.  Since this is an “intent to treat” design, patients that 
miss treatments are not removed from the study.  However, post-hoc analyses will 
examine the effects of compliance on overall outcome.  
6. 
Evaluations 
Patients are first tested for “remission” after the first 20 sessions of treatment and 
then again at the 25th and 30th sessions.  Remission is defined as a decrease in 
Hamilton Rating Scale for Depression to 10 or less.  If a patient enters “remission” 
after 20 sessions, then they enter a 24-week follow-up period.  If a patient does not 
enter “remission” at the end of 20 sessions, they are offered an additional 5 sessions 
of treatment and retested for “remission.”  This procedure may continue for a 

 
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maximum of 10 additional sessions resulting in a total of 30 sessions.  Patients who 
do not show a treatment response at the end of 30 sessions of treatment or who drop 
out during treatment will be considered a treatment “failure”.   
At the end of the acute treatment phase, all patients will be entered into a 24 week 
follow-up phase.  Participants who remit will receive a 3 week treatment taper at the 
beginning of the follow-up phase.  The taper will include 3 treatment sessions in the 
first week, 2 in the second week and 1 in the last week of the taper. 
7. 
Sham (Control) rTMS Treatment  
Sham (Control) treatment will be accomplished by using the Cool-B65-A/P coil that 
functions both as an active (A) and placebo (P) coil. It has a symmetrical mechanical 
design and no labeling on the coil indicates the active or placebo side. Consequently 
it is not possible for the operator to see or hear which side is used.  
8. 
Masking 
Every attempt will be made to mask the patient and the treatment administrator to the 
treatment group assignment, as will all personnel at each clinical site. Each site will 
be supplied with 2 coils; one C-B60 coil for MT determination and one Cool-B65 A/P 
coil for treatment.  
Additionally, for each treatment session, whether sham or active, each patient shall 
wear scalp electrodes through which, in the case of sham treatments, a low-voltage, 
low electric current (2 – 20ma at no more than 100V) will be passed in order to 
provide cutaneous stimulation that mimics the sensation of actual rTMS.  At the same 
time, the Sham Noise Generator is used in order to hide the click noise. When a 
magnetic stimulation pulse is fired, white noise is sent to the ears of the patient. This 
sham noise pulse will hide the click noise from the coil for the patient. The treatment 
administrator also receives the sham noise. 
To further assess the adequacy of the mask, rTMS administrators, clinical raters, and 
patients will complete a Control Questionnaire at the time of the final study visit to 
assess their “best guess” as to treatment condition, and their level of confidence in 

 
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this guess.  Successful blinding of experienced rTMS administrators determined to 
break the blind with this method has been piloted by Drs. George and Nahas, and 
found to be successful.  

 
 
 
 
 
 
 
 
 
 
APPENDIX L 
 
 
Ethics: Belmont Report  

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The Belmont Report  
 
Office of the Secretary  
 
Ethical Principles and Guidelines for the Protection of Human  
Subjects of Research  
 
The National Commission for the Protection of Human Subjects  
of Biomedical and Behavioral Research 
 
April 18, 1979 
 
AGENCY: Department of Health, Education, and Welfare.  
ACTION: Notice of Report for Public Comment.  
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into 
law, there-by creating the National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research. One of the charges to the Commission was to identify the 
basic ethical principles that should underlie the conduct of biomedical and behavioral research 
involving human subjects and to develop guidelines which should be followed to assure that such 
research is conducted in accordance with those principles. In carrying out the above, the 
Commission was directed to consider: (i) the boundaries between biomedical and behavioral 
research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-
benefit criteria in the determination of the appropriateness of research involving human subjects, 
(iii) appropriate guidelines for the selection of human subjects for participation in such research 
and (iv) the nature and definition of informed consent in various research settings.  
The Belmont Report attempts to summarize the basic ethical principles identified by the 
Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period 
of discussions that were held in February 1976 at the Smithsonian Institution's Belmont 
Conference Center supplemented by the monthly deliberations of the Commission that were held 
over a period of nearly four years. It is a statement of basic ethical principles and guidelines that 
should assist in resolving the ethical problems that surround the conduct of research with human 
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, 
the Secretary intends that it may be made readily available to scientists, members of Institutional 
Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy 
reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, 
is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the 
Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.  
Unlike most other reports of the Commission, the Belmont Report does not make specific 
recommendations for administrative action by the Secretary of Health, Education, and Welfare. 
Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a 
statement of the Department's policy. The Department requests public comment on this 
recommendation. 

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National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research 
 
Members of the Commission 
 
Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.  
Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.  
Robert E. Cooke, M.D., President, Medical College of Pennsylvania.  
Dorothy I. Height, President, National Council of Negro Women, Inc.  
Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San 
Francisco.  
Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.  
Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.  
*** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.  
Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University 
of Texas at Dallas.  
***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, 
University of Pennsylvania.  
*** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C. 
*** Deceased.  
 
 
Table of Contents 
 
Ethical Principles and Guidelines for Research Involving Human Subjects  
 
A. Boundaries Between Practice and Research 
 
B. Basic Ethical Principles 
 
1. Respect for Persons  
 
2. Beneficence  
 
3. Justice 
 
C. Applications 
 
1. Informed Consent  
 
2. Assessment of Risk and Benefits  
 
3. Selection of Subjects  

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Ethical Principles & Guidelines for Research Involving Human Subjects 
 
 
Scientific research has produced substantial social benefits. It has also posed some 
troubling ethical questions. Public attention was drawn to these questions by reported abuses of 
human subjects in biomedical experiments, especially during the Second World War. During the 
Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging 
physicians and scientists who had conducted biomedical experiments on concentration camp 
prisoners. This code became the prototype of many later codes(1) intended to assure that research 
involving human subjects would be carried out in an ethical manner.  
The codes consist of rules, some general, others specific, that guide the investigators or the 
reviewers of research in their work. Such rules often are inadequate to cover complex situations; 
at times they come into conflict, and they are frequently difficult to interpret or apply. Broader 
ethical principles will provide a basis on which specific rules may be formulated, criticized and 
interpreted.  
 
 
Three principles, or general prescriptive judgments, that are relevant to research 
involving human subjects are identified in this statement. Other principles may also be relevant. 
These three are comprehensive, however, and are stated at a level of generalization that should 
assist scientists, subjects, reviewers and interested citizens to understand the ethical issues 
inherent in research involving human subjects. These principles cannot always be applied so as 
to resolve beyond dispute particular ethical problems. The objective is to provide an analytical 
framework that will guide the resolution of ethical problems arising from research involving 
human subjects.  
 
 
This statement consists of a distinction between research and practice, a discussion of the 
three basic ethical principles, and remarks about the application of these principles. 
 
Part A: Boundaries Between Practice & Research 
 
A.  Boundaries Between Practice and Research  
 
 
It is important to distinguish between biomedical and behavioral research, on the one 
hand, and the practice of accepted therapy on the other, in order to know what activities ought to 
undergo review for the protection of human subjects of research. The distinction between 
research and practice is blurred partly because both often occur together (as in research designed 
to evaluate a therapy) and partly because notable departures from standard practice are often 
called "experimental" when the terms "experimental" and "research" are not carefully defined.  
 
 
For the most part, the term "practice" refers to interventions that are designed solely to 
enhance the well-being of an individual patient or client and that have a reasonable expectation 
of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive 
treatment or therapy to particular individuals.(2) By contrast, the term "research" designates an 
activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or 
contribute to generalizable knowledge (expressed, for example, in theories, principles, and 

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statements of relationships). Research is usually described in a formal protocol that sets forth an 
objective and a set of procedures designed to reach that objective.  
 
 
When a clinician departs in a significant way from standard or accepted practice, the 
innovation does not, in and of itself, constitute research. The fact that a procedure is 
"experimental," in the sense of new, untested or different, does not automatically place it in the 
category of research. Radically new procedures of this description should, however, be made the 
object of formal research at an early stage in order to determine whether they are safe and 
effective. Thus, it is the responsibility of medical practice committees, for example, to insist that 
a major innovation be incorporated into a formal research project.(3)  
 
 
Research and practice may be carried on together when research is designed to evaluate 
the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not 
the activity requires review; the general rule is that if there is any element of research in an 
activity, that activity should undergo review for the protection of human subjects. 
Part B: Basic Ethical Principles 
 
B. Basic Ethical Principles  
 
 
The expression "basic ethical principles" refers to those general judgments that serve as a 
basic justification for the many particular ethical prescriptions and evaluations of human actions. 
Three basic principles, among those generally accepted in our cultural tradition, are particularly 
relevant to the ethics of research involving human subjects: the principles of respect of persons, 
beneficence and justice.  
 
1. Respect for Persons.—Respect for persons incorporates at least two ethical convictions: first, 
that individuals should be treated as autonomous agents, and second, that persons with 
diminished autonomy are entitled to protection. The principle of respect for persons thus divides 
into two separate moral requirements: the requirement to acknowledge autonomy and the 
requirement to protect those with diminished autonomy.  
 
 
An autonomous person is an individual capable of deliberation about personal goals and 
of acting under the direction of such deliberation. To respect autonomy is to give weight to 
autonomous persons' considered opinions and choices while refraining from obstructing their 
actions unless they are clearly detrimental to others. To show lack of respect for an autonomous 
agent is to repudiate that person's considered judgments, to deny an individual the freedom to act 
on those considered judgments, or to withhold information necessary to make a considered 
judgment, when there are no compelling reasons to do so.  
 
 
However, not every human being is capable of self-determination. The capacity for self-
determination matures during an individual's life, and some individuals lose this capacity wholly 
or in part because of illness, mental disability, or circumstances that severely restrict liberty. 
Respect for the immature and the incapacitated may require protecting them as they mature or 
while they are incapacitated.  
 

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Some persons are in need of extensive protection, even to the point of excluding them 
from activities which may harm them; other persons require little protection beyond making sure 
they undertake activities freely and with awareness of possible adverse consequence. The extent 
of protection afforded should depend upon the risk of harm and the likelihood of benefit. The 
judgment that any individual lacks autonomy should be periodically reevaluated and will vary in 
different situations.  
 
 
In most cases of research involving human subjects, respect for persons demands that 
subjects enter into the research voluntarily and with adequate information. In some situations, 
however, application of the principle is not obvious. The involvement of prisoners as subjects of 
research provides an instructive example. On the one hand, it would seem that the principle of 
respect for persons requires that prisoners not be deprived of the opportunity to volunteer for 
research. On the other hand, under prison conditions they may be subtly coerced or unduly 
influenced to engage in research activities for which they would not otherwise volunteer. Respect 
for persons would then dictate that prisoners be protected. Whether to allow prisoners to 
"volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is 
often a matter of balancing competing claims urged by the principle of respect itself.  
 
2. Beneficence.—Persons are treated in an ethical manner not only by respecting their decisions 
and protecting them from harm, but also by making efforts to secure their well-being. Such 
treatment falls under the principle of beneficence. The term "beneficence" is often understood to 
cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence 
is understood in a stronger sense, as an obligation. Two general rules have been formulated as 
complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize 
possible benefits and minimize possible harms.  
 
 
The Hippocratic maxim "do no harm" has long been a fundamental principle of medical 
ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one 
person regardless of the benefits that might come to others. However, even avoiding harm 
requires learning what is harmful; and, in the process of obtaining this information, persons may 
be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their 
patients "according to their best judgment." Learning what will in fact benefit may require 
exposing persons to risk. The problem posed by these imperatives is to decide when it is 
justifiable to seek certain benefits despite the risks involved, and when the benefits should be 
foregone because of the risks.  
 
 
The obligations of beneficence affect both individual investigators and society at large, 
because they extend both to particular research projects and to the entire enterprise of research. 
In the case of particular projects, investigators and members of their institutions are obliged to 
give forethought to the maximization of benefits and the reduction of risk that might occur from 
the research investigation. In the case of scientific research in general, members of the larger 
society are obliged to recognize the longer term benefits and risks that may result from the 
improvement of knowledge and from the development of novel medical, psychotherapeutic, and 
social procedures.  
 

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The principle of beneficence often occupies a well-defined justifying role in many areas 
of research involving human subjects. An example is found in research involving children. 
Effective ways of treating childhood diseases and fostering healthy development are benefits that 
serve to justify research involving children—even when individual research subjects are not 
direct beneficiaries. Research also makes it possible to avoid the harm that may result from the 
application of previously accepted routine practices that on closer investigation turn out to be 
dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult 
ethical problem remains, for example, about research that presents more than minimal risk 
without immediate prospect of direct benefit to the children involved. Some have argued that 
such research is inadmissible, while others have pointed out that this limit would rule out much 
research promising great benefit to children in the future. Here again, as with all hard cases, the 
different claims covered by the principle of beneficence may come into conflict and force 
difficult choices.  
 
3. Justice.—Who ought to receive the benefits of research and bear its burdens? This is a 
question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice 
occurs when some benefit to which a person is entitled is denied without good reason or when 
some burden is imposed unduly. Another way of conceiving the principle of justice is that equals 
ought to be treated equally. However, this statement requires explication. Who is equal and who 
is unequal? What considerations justify departure from equal distribution? Almost all 
commentators allow that distinctions based on experience, age, deprivation, competence, merit 
and position do sometimes constitute criteria justifying differential treatment for certain 
purposes. It is necessary, then, to explain in what respects people should be treated equally. 
There are several widely accepted formulations of just ways to distribute burdens and benefits. 
Each formulation mentions some relevant property on the basis of which burdens and benefits 
should be distributed. These formulations are (1) to each person an equal share, (2) to each 
person according to individual need, (3) to each person according to individual effort, (4) to each 
person according to societal contribution, and (5) to each person according to merit.  
 
 
Questions of justice have long been associated with social practices such as punishment, 
taxation and political representation. Until recently these questions have not generally been 
associated with scientific research. However, they are foreshadowed even in the earliest 
reflections on the ethics of research involving human subjects. For example, during the 19th and 
early 20th centuries the burdens of serving as research subjects fell largely upon poor ward 
patients, while the benefits of improved medical care flowed primarily to private patients. 
Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration 
camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the 
Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a 
disease that is by no means confined to that population. These subjects were deprived of 
demonstrably effective treatment in order not to interrupt the project, long after such treatment 
became generally available.  
 
 
Against this historical background, it can be seen how conceptions of justice are relevant 
to research involving human subjects. For example, the selection of research subjects needs to be 
scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial 
and ethnic minorities, or persons confined to institutions) are being systematically selected 

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simply because of their easy availability, their compromised position, or their manipulability, 
rather than for reasons directly related to the problem being studied. Finally, whenever research 
supported by public funds leads to the development of therapeutic devices and procedures, 
justice demands both that these not provide advantages only to those who can afford them and 
that such research should not unduly involve persons from groups unlikely to be among the 
beneficiaries of subsequent applications of the research. 
Part C: Applications 
C. Applications  
 
 
Applications of the general principles to the conduct of research leads to consideration of 
the following requirements: informed consent, risk/benefit assessment, and the selection of 
subjects of research.  
 
1. Informed Consent.—Respect for persons requires that subjects, to the degree that they are 
capable, be given the opportunity to choose what shall or shall not happen to them. This 
opportunity is provided when adequate standards for informed consent are satisfied.  
 
 
While the importance of informed consent is unquestioned, controversy prevails over the 
nature and possibility of an informed consent. Nonetheless, there is widespread agreement that 
the consent process can be analyzed as containing three elements: information, comprehension 
and voluntariness.  
 
Information. Most codes of research establish specific items for disclosure intended to assure 
that subjects are given sufficient information. These items generally include: the research 
procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is 
involved), and a statement offering the subject the opportunity to ask questions and to withdraw 
at any time from the research. Additional items have been proposed, including how subjects are 
selected, the person responsible for the research, etc.  
 
 
However, a simple listing of items does not answer the question of what the standard 
should be for judging how much and what sort of information should be provided. One standard 
frequently invoked in medical practice, namely the information commonly provided by 
practitioners in the field or in the locale, is inadequate since research takes place precisely when 
a common understanding does not exist. Another standard, currently popular in malpractice law, 
requires the practitioner to reveal the information that reasonable persons would wish to know in 
order to make a decision regarding their care. This, too, seems insufficient since the research 
subject, being in essence a volunteer, may wish to know considerably more about risks 
gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for 
needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the 
extent and nature of information should be such that persons, knowing that the procedure is 
neither necessary for their care nor perhaps fully understood, can decide whether they wish to 
participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, 
the subjects should understand clearly the range of risk and the voluntary nature of participation.  
 
 
A special problem of consent arises where informing subjects of some pertinent aspect of 
the research is likely to impair the validity of the research. In many cases, it is sufficient to 

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indicate to subjects that they are being invited to participate in research of which some features 
will not be revealed until the research is concluded. In all cases of research involving incomplete 
disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly 
necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects 
that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when 
appropriate, and for dissemination of research results to them. Information about risks should 
never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers 
should always be given to direct questions about the research. Care should be taken to 
distinguish cases in which disclosure would destroy or invalidate the research from cases in 
which disclosure would simply inconvenience the investigator.  
 
Comprehension. The manner and context in which information is conveyed is as important as 
the information itself. For example, presenting information in a disorganized and rapid fashion, 
allowing too little time for consideration or curtailing opportunities for questioning, all may 
adversely affect a subject's ability to make an informed choice.  
 
 
Because the subject's ability to understand is a function of intelligence, rationality, 
maturity and language, it is necessary to adapt the presentation of the information to the subject's 
capacities. Investigators are responsible for ascertaining that the subject has comprehended the 
information. While there is always an obligation to ascertain that the information about risk to 
subjects is complete and adequately comprehended, when the risks are more serious, that 
obligation increases. On occasion, it may be suitable to give some oral or written tests of 
comprehension.  
 
 
Special provision may need to be made when comprehension is severely limited—for 
example, by conditions of immaturity or mental disability. Each class of subjects that one might 
consider as incompetent (e.g., infants and young children, mentally disable patients, the 
terminally ill and the comatose) should be considered on its own terms. Even for these persons, 
however, respect requires giving them the opportunity to choose to the extent they are able, 
whether or not to participate in research. The objections of these subjects to involvement should 
be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect 
for persons also requires seeking the permission of other parties in order to protect the subjects 
from harm. Such persons are thus respected both by acknowledging their own wishes and by the 
use of third parties to protect them from harm.  
 
 
The third parties chosen should be those who are most likely to understand the 
incompetent subject's situation and to act in that person's best interest. The person authorized to 
act on behalf of the subject should be given an opportunity to observe the research as it proceeds 
in order to be able to withdraw the subject from the research, if such action appears in the 
subject's best interest.  
 
Voluntariness. An agreement to participate in research constitutes a valid consent only if 
voluntarily given. This element of informed consent requires conditions free of coercion and 
undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one 
person to another in order to obtain compliance. Undue influence, by contrast, occurs through an 
offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order 

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to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue 
influences if the subject is especially vulnerable.  
 
 
Unjustifiable pressures usually occur when persons in positions of authority or 
commanding influence—especially where possible sanctions are involved—urge a course of 
action for a subject. A continuum of such influencing factors exists, however, and it is 
impossible to state precisely where justifiable persuasion ends and undue influence begins. But 
undue influence would include actions such as manipulating a person's choice through the 
controlling influence of a close relative and threatening to withdraw health services to which an 
individual would otherwise be entitle.  
 
2. Assessment of Risks and Benefits.—The assessment of risks and benefits requires a careful 
arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits 
sought in the research. Thus, the assessment presents both an opportunity and a responsibility to 
gather systematic and comprehensive information about proposed research. For the investigator, 
it is a means to examine whether the proposed research is properly designed. For a review 
committee, it is a method for determining whether the risks that will be presented to subjects are 
justified. For prospective subjects, the assessment will assist the determination whether or not to 
participate.  
 
The Nature and Scope of Risks and Benefits. The requirement that research be justified on the 
basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, 
just as the moral requirement that informed consent be obtained is derived primarily from the 
principle of respect for persons. The term "risk" refers to a possibility that harm may occur. 
However, when expressions such as "small risk" or "high risk" are used, they usually refer (often 
ambiguously) both to the chance (probability) of experiencing a harm and the severity 
(magnitude) of the envisioned harm.  
 
 
The term "benefit" is used in the research context to refer to something of positive value 
related to health or welfare. Unlike, "risk," "benefit" is not a term that expresses probabilities. 
Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with 
harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned 
with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of 
possible harms and benefits need to be taken into account. There are, for example, risks of 
psychological harm, physical harm, legal harm, social harm and economic harm and the 
corresponding benefits. While the most likely types of harms to research subjects are those of 
psychological or physical pain or injury, other possible kinds should not be overlooked.  
 
 
Risks and benefits of research may affect the individual subjects, the families of the 
individual subjects, and society at large (or special groups of subjects in society). Previous codes 
and Federal regulations have required that risks to subjects be outweighed by the sum of both the 
anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of 
knowledge to be gained from the research. In balancing these different elements, the risks and 
benefits affecting the immediate research subject will normally carry special weight. On the 
other hand, interests other than those of the subject may on some occasions be sufficient by 
themselves to justify the risks involved in the research, so long as the subjects' rights have been 

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protected. Beneficence thus requires that we protect against risk of harm to subjects and also that 
we be concerned about the loss of the substantial benefits that might be gained from research.  
 
The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks 
must be "balanced" and shown to be "in a favorable ratio." The metaphorical character of these 
terms draws attention to the difficulty of making precise judgments. Only on rare occasions will 
quantitative techniques be available for the scrutiny of research protocols. However, the idea of 
systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. 
This ideal requires those making decisions about the justifiability of research to be thorough in 
the accumulation and assessment of information about all aspects of the research, and to consider 
alternatives systematically. This procedure renders the assessment of research more rigorous and 
precise, while making communication between review board members and investigators less 
subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first 
be a determination of the validity of the presuppositions of the research; then the nature, 
probability and magnitude of risk should be distinguished with as much clarity as possible. The 
method of ascertaining risks should be explicit, especially where there is no alternative to the use 
of such vague categories as small or slight risk. It should also be determined whether an 
investigator's estimates of the probability of harm or benefits are reasonable, as judged by known 
facts or other available studies.  
 
 
Finally, assessment of the justifiability of research should reflect at least the following 
considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) 
Risks should be reduced to those necessary to achieve the research objective. It should be 
determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be 
entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) 
When research involves significant risk of serious impairment, review committees should be 
extraordinarily insistent on the justification of the risk (looking usually to the likelihood of 
benefit to the subject—or, in some rare cases, to the manifest voluntariness of the participation). 
(iv) When vulnerable populations are involved in research, the appropriateness of involving them 
should itself be demonstrated. A number of variables go into such judgments, including the 
nature and degree of risk, the condition of the particular population involved, and the nature and 
level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in 
documents and procedures used in the informed consent process.  
 
3. Selection of Subjects.—Just as the principle of respect for persons finds expression in the 
requirements for consent, and the principle of beneficence in risk/benefit assessment, the 
principle of justice gives rise to moral requirements that there be fair procedures and outcomes in 
the selection of research subjects.  
 
 
Justice is relevant to the selection of subjects of research at two levels: the social and the 
individual. Individual justice in the selection of subjects would require that researchers exhibit 
fairness: thus, they should not offer potentially beneficial research only to some patients who are 
in their favor or select only "undesirable" persons for risky research. Social justice requires that 
distinction be drawn between classes of subjects that ought, and ought not, to participate in any 
particular kind of research, based on the ability of members of that class to bear burdens and on 
the appropriateness of placing further burdens on already burdened persons. Thus, it can be 

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considered a matter of social justice that there is an order of preference in the selection of classes 
of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the 
institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only 
on certain conditions.  
 
 
Injustice may appear in the selection of subjects, even if individual subjects are selected 
fairly by investigators and treated fairly in the course of research. Thus injustice arises from 
social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual 
researchers are treating their research subjects fairly, and even if IRBs are taking care to assure 
that subjects are selected fairly within a particular institution, unjust social patterns may 
nevertheless appear in the overall distribution of the burdens and benefits of research. Although 
individual institutions or investigators may not be able to resolve a problem that is pervasive in 
their social setting, they can consider distributive justice in selecting research subjects.  
 
 
Some populations, especially institutionalized ones, are already burdened in many ways 
by their infirmities and environments. When research is proposed that involves risks and does 
not include a therapeutic component, other less burdened classes of persons should be called 
upon first to accept these risks of research, except where the research is directly related to the 
specific conditions of the class involved. Also, even though public funds for research may often 
flow in the same directions as public funds for health care, it seems unfair that populations 
dependent on public health care constitute a pool of preferred research subjects if more 
advantaged populations are likely to be the recipients of the benefits.  
 
 
One special instance of injustice results from the involvement of vulnerable subjects. 
Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the 
institutionalized may continually be sought as research subjects, owing to their ready availability 
in settings where research is conducted. Given their dependent status and their frequently 
compromised capacity for free consent, they should be protected against the danger of being 
involved in research solely for administrative convenience, or because they are easy to 
manipulate as a result of their illness or socioeconomic condition. 

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(1) Since 1945, various codes for the proper and responsible conduct of human experimentation in 
medical research have been adopted by different organizations. The best known of these codes 
are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 
1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of 
Health, Education, and Welfare Codes for the conduct of social and behavioral research have 
also been adopted, the best known being that of the American Psychological Association, 
published in 1973.  
 
(2) Although practice usually involves interventions designed solely to enhance the well-being of 
a particular individual, interventions are sometimes applied to one individual for the 
enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) 
or an intervention may have the dual purpose of enhancing the well-being of a particular 
individual, and, at the same time, providing some benefit to others (e.g., vaccination, which 
protects both the person who is vaccinated and society generally). The fact that some forms of 
practice have elements other than immediate benefit to the individual receiving an 
intervention, however, should not confuse the general distinction between research and 
practice. Even when a procedure applied in practice may benefit some other person, it remains 
an intervention designed to enhance the well-being of a particular individual or groups of 
individuals; thus, it is practice and need not be reviewed as research.  
 
(3) Because the problems related to social experimentation may differ substantially from those of 
biomedical and behavioral research, the Commission specifically declines to make any policy 
determination regarding such research at this time. Rather, the Commission believes that the 
problem ought to be addressed by one of its successor bodies. 
 
 

 
 
APPENDIX  M 
 
 
 
HEALTH ECONOMICS AND COST ANALYSIS  
 
 

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A.   
Overview 
The proposed project will compare the effectiveness of rTMS to that of sham-rTMS 
among patients with treatment-resistant major depression participating in CSP 556.  The 
economic analysis will comprise three parts: (1) cost-identification analysis to document the cost 
of the intervention; (2) a cost-consequences analysis to estimate its impact in both short- and 
long-term time horizons (i.e., 24-weeks post-treatment, and 4- to 12-months post-treatment, 
respectively); and (3) a cost-effectiveness analysis for rTMS therapy.  The intervention cost-
identification analysis will document the expected cost of the intervention to the VA in a typical 
site.  The cost-consequences analysis will compare the difference in average total and average 
variable costs of care during a one-year period between rTMS therapy and usual outpatient 
depression care for treatment-resistant patients.  The cost-effectiveness analysis will calculate 
the average incremental treatment cost per incremental depression remission for these same 
participants and time period.  Remission is defined as a Hamilton depression score less than 
10.   
An economic analysis is central to CSP 556, because any future plan to implement 
rTMS technology within VHA will require estimates of the expected investment cost for new 
equipment, staff time, and other resources and because any decision to invest substantial new 
resources into rTMS therapy may depend on its expected effects on services utilization, cost, 
and patients’ health status balanced against that investment.  
A VA payer perspective will be adopted for the analyses.  Although a broader societal 
viewpoint is often used in cost-effectiveness research,1 the primary rationale for the economic 
analysis component in this study is to provide information to VA managers and administrators 
about the likely budgetary plus indirect health care resource impacts of rTMS implementation 
and diffusion.  It is critical that VA administrators have preliminary evidence on economic 
impacts to inform their decisions about the extent and timing of any investment in rTMS 
technology.  A secondary rationale is to demonstrate the cost-effectiveness of rTMS within an 
integrated system of care vis-à-vis usual care received by patients with treatment-resistant 
major depression.  The planned cost-effectiveness analysis will provide information about the 
improvements in depressive symptoms that may result from an investment in rTMS as 
compared to standard care.   
We will combine both micro-costing and gross (or “average”) costing methodologies in 
deriving these cost estimates, as has been recommended for cost-effectiveness research in the 

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VA health care system.2  We will use micro-costing methods to estimate the cost of rTMS 
therapy. We will use average costing methods for other health care costs.  The more labor-
intensive micro-costing method, where the quantity of each production input is counted, 
quantities are multiplied by input unit costs, and input costs are added together, is reserved for 
components of the analysis where precision is paramount or where alternatives are not 
available.  Gross costing, where the average cost of finished products and services are used, is 
used for remaining components.  Costs will be expressed in current-year dollars, or “nominal 
dollars”.  Past and future costs will be inflated and discounted, respectively, following 
recommended guidelines. 
Three elements are needed to perform these cost and cost-effectiveness analyses: 
clinical outcomes, health care utilization data, and value data for assigning costs to utilization.  
The sources of information for these elements may be summarized as follows.  Health 
outcomes will be determined from patient interviews.   Health care utilization will be determined 
from national VA data systems and CSP study forms.  Cost data will be extracted from national 
data systems when possible and from published sources or VA administrators as needed.  The 
range of costs considered will include: direct inpatient and outpatient care costs; indirect costs 
for staff time; and direct and indirect costs associated with use of equipment and office space 
and with use of other physical and administrative resources. 
A key component of the economic analysis is our strategy for estimating usual care 
costs in a comparison group representing "usual care."  A customized imputation approach is 
required for this component, because the randomized trial does not include a “treatment as 
usual” study arm.  Patients assigned to the trial's comparison or “placebo” group will receive 
sham rTMS.  Sham treatment does not resemble usual care for treatment-resistant patients in 
the VA.  Patients assigned to sham will attend up to 30 sham rTMS sessions (see Figure 1, 
“Patient Flow in Study”).  Patients who do not achieve remission (HRSD<=10) after the first 20 
sham rTMS sessions will attend additional sham rTMS sessions.  Thus, the expected cost of 
usual care during the acute treatment phase of the trial, which will last from 4 to 11 weeks, must 
be imputed for all patients receiving sham rTMS.   These imputed costs will be added together 
with actual costs during the follow-up phase to estimate the cost of usual care for treatment-
resistant patients in the comparison group.  We provide further details on the imputation method 
and related sensitivity analyses below. 
 
 
 

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Figure 1.  Patient Flow in Study (in Main Proposal) 
Sign Consent
Screening Assessments
Randomization
Screening
2-4 Weeks
Active rTMS
x 20 sessions
Acute Treatment Phase
4-11 Weeks
Additional Active rTMS
5-10 sessions MAX
Follow-up 24 weeks
No Taper
Remit?
(HRSD < 10)
Remit?
(HRSD < 10)
Follow-up Phase
24 Weeks
Treatment Taper and 
Follow-up 24 weeks
No
No
Sham rTMS
x 20 sessions
Additional Sham rTMS
5-10 sessions MAX
Follow-up 24 weeks
No Taper
Remit?
(HRSD < 10)
Remit?
(HRSD < 10)
No
No
Yes
Yes
Yes
Yes

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B.   
Objectives 
 
It cannot be known a priori if rTMS therapy will increase or reduce usual VA health care costs 
associated with treatment-resistant depression.  This innovation, rTMS, may increase costs 
during the acute treatment phase due to more frequent contact with outpatient providers, 
greater frequency of lab tests, use of an expensive rTMS medical device, and greater use of 
other resources.  However, these extra costs could be partially or completely offset by savings 
from reduced likelihood of later hospitalization, reduced likelihood of receiving electroconvulsive 
therapy (ECT), reduced use of psychotropic medications, and/or reduced frequency of 
depression-related medical encounters.  If rTMS therapy increases the likelihood of a full 
remission and/or reduces the likelihood of a recurrence, cost-offset effects will tend to 
accumulate over time.  Because there is presently little evidence on the cost and effectiveness 
of rTMS in usual clinical settings, the magnitude of shorter and longer term potential cost 
differences between rTMS and usual care are unknown.   Two hypotheses about the short-term 
(24-weeks post-treatment) and longer term (6- to 12-months post-treatment) cost consequences 
of rTMS therapy will therefore be tested: 
1. Relative to usual care, total direct and indirect VA costs related to rTMS therapy for 
treatment-resistant depression will be less than total costs associated with usual care 
at 6-weeks post-treatment. 
2. Relative to usual care, total direct and indirect VA costs related to rTMS therapy for 
treatment-resistant depression will be less than total costs associated with usual care 
at 6- to 12-months post-treatment. 
 
The short-term 24-week period was chosen to coincide with the collection of clinical 
endpoints at the end of the CSP 556 follow-up phase.  The longer term 6- to 12-month period 
was chosen to maximize the opportunity to observe cost offsets from rTMS.  The reason for 
specifying 6- to 12-months rather than a single time period is that due to extant data lags we do 
not know in advance how long of a retrospective period will be available to us, given the 
potential variability in the timing of patient recruitment.  Maximization of sample size is 
paramount to accurate cost estimation.  Therefore, we will select the longest 6- to 12-month 
post-treatment period that will allow us to include the largest sample of study participants.  We 
believe that nearly all patients will have completed treatment and will have 6-months post-
treatment cost data available before the end of the three-year study.  A longer cost 
consequence follow-up will be pursued, if the extant data are available.  Cost consequences 

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results will be discussed in terms of statistical significance and the magnitude and types of 
differences (e.g., inpatient and outpatient).   
 
We will then estimate the cost-effectiveness of rTMS therapy in producing a sustained 
remission from depression (HRSD<=10) at 24-weeks post-treatment.  We will report the 
incremental cost of rTMS per incremental remission, which will provide a standardized measure 
of the cost-effectiveness of rTMS therapy relative to that of “usual outpatient care”.  These 
estimates will allow us to test a third hypothesis: 
3. 
Relative to usual care, rTMS therapy for treatment-resistant depression is cost-
effective in producing a sustained remission from acute depressive symptoms, in 
outpatients.   
We will calculate a 95% confidence region for all estimated cost-effectiveness ratios.  
The ratios will be discussed in light of the cost-effectiveness of antidepressant medication and 
ECT.   Estimates for these alternative therapies are available from published studies.3, 4  
 
C.  
Background 
 
1.  
Prevalence 
In the VA there may be roughly 100,000 treatment-resistant patients.5-8  Prevalence 
estimates for treatment-resistant depression that are derived from general community samples 
indicate that up to 20% of patients with depression disorders are treatment-resistant.6-8  Even 
this number could underestimate the actual number of VA patients with treatment-resistant 
depression, where more difficult patients are often expected.  First, many VA treatment-resistant 
patients may discontinue antidepressant medication use altogether, and therefore are not 
counted among current medication users.   Second, the rate of treatment resistance among VA 
patients could be greater than in the community: VA patients could have higher rates of 
substance abuse and anxiety disorders, which are associated with higher rates of treatment 
resistance.9   
 
2.  
 Treatment Costs 
Annual VA health care costs associated with treatment resistance among patients with 
depression could represent roughly $580 million.  In FY02, the VA spent approximately $3 
billion for medical and psychiatric care for patients with unipolar depression diagnoses, or 
approximately $5,535 per depression patient.5  In community samples of patients with 
depression, health care costs among treatment-resistant patients are at least 2-times the mean 
costs of non-treatment-resistant patients.6, 7, 10, 11  This suggests treatment costs among 

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treatment-resistant patients in the VA could exceed the costs for non-treatment-resistant 
patients by more than $5,800 per patient per year.   
One goal of this proposed economic study is to establish some bounds for the likely cost 
impact of rTMS.  The magnitude of any cost-offset depends on the effectiveness of rTMS 
compared with antidepressant or other therapy among treatment-resistant patients and on the 
relationship between depressive symptoms and services utilization.   Recurrently elevated  
depressive symptoms may to some extent contribute to these patients’ relatively higher  
psychiatric as well as general medical services costs.  An effective therapy could potentially 
lower their psychiatric as well as their general medical care costs.  However, these relationships 
have not been established in prior research, so the potential cost impacts of rTMS technology 
are unknown.  Because of the extensive, standardized data systems in the VA, this investigation 
can be conducted during the CSP 556 trial.   
A final important point is that an effective alternative to electro-convulsive therapy (ECT) 
would fill a void in the current VA treatment arsenal for patients who do not respond fully to 
antidepressant therapy.   ECT is not offered at all VHA facilities.  Access to ECT is also limited 
because of its high cost and because of administrative and logistical barriers, such as the need 
for ECT patients to receive anesthesia.  rTMS could provide another treatment option, one that 
could be disseminated widely, both to larger as well as to smaller outpatient treatment settings.  
Thus, even though rTMS might increase VA’s expenditures for depression care, rTMS could 
benefit the health of patients who currently have limited access to effective treatment.   
3.  
Health Economics and Treatment Resistance 
The health economics literature on treatment resistance consists of only a few studies.  
Virtually all have focused on its association with health care costs.6, 7, 10, 11  Prior studies have 
been based on estimates from private employer claims data, which may underestimate both its 
prevalence and its cost.  The validity and reliability of measures of treatment resistance in 
administrative claims data have also not been verified.  Obvious problems include reliance on 
an incomplete history of depression treatment, misidentification of depression based on claims 
diagnosis, and underreporting of depression diagnoses by physicians (e.g., due to concerns 
about insurance reimbursement).  In the proposed CSP 556 study, treatment resistance will be 
determined through clinical interview, thereby allowing us to extend the literature on cost 
estimates using a more valid measure of cases.  The correlation of clinical interview-based and 
administrative data-based case identification can also be examined, with estimates of the 

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systematic biases of claims-based case identification and associated costs of care derived from 
these data.  These would be valuable contribution to this limited literature.   
 
D. 
Analyses 
1. 
Cost and Utilization Data 
Data Sources.  Table 1 summarizes constituent components of utilization and cost and 
their corresponding data sources.  Components are divided by whether they will be used to  
measure costs for active rTMS only (Tx Group = Active) or for both sham and active rTMS (Tx 
Group = Both).   Health care utilization will be determined from national VA data systems, 
patient responses recorded on study forms, and study case report forms (adverse events, in 
particular).  Cost estimates will be derived from national VA data systems, published sources, 
and accounting values provided by VA administrators. 
We will use centralized VA databases to obtain the health care services used by the trial 
participants.  From the database of VA inpatient hospital stays, the Patient Treatment File 
(PTF), we will obtain the date of discharge, days of stay in each ward (bedsection), including the 
number of days in intensive care, and the ICD-9 diagnoses (up to 10 codes) assigned to the 
stay.  Then, we will obtain from the outpatient care file (OPC), the date of the visit, the location 
of care (stop code), and ICD-9 diagnoses (up to ten) and CPT codes (up to five) assigned to 
describe the visit and the type of provider.  All major types of outpatient care are captured, 
including mental health and substance abuse as well as general medical services utilization.   
The cost of other care (including diagnostic tests) will be obtained from detailed utilization data, 
which is available from centralized VA Austin databases.  National VA utilization databases 
(PTF and OPC) lack cost estimates, but they can be merged to the Health Economics Resource 
Center (HERC) average cost database, and accepted methods applied. 
 
 

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Table 1. Resource Utilization and Associated Costs 
 
Tx Phase/Resource Category 
Tx Group 
Primary Source(s) and Notes 
 Pre-screening for patient safety 
Active 
Case report forms and provider wage rates 
 Treatment for rTMS-related adverse 
medical events 
Active 
Adverse events reporting forms, OPC and 
PTF, and administrative HERC files. We 
will link study data on adverse events with 
administrative data on services utilization 
and costs.  
 rTMS 
device 
and 
associated 
physical  equipment costs 
Active 
Equipment prices will be obtained from 
study investigators.  Average per session 
expense will be imputed using straight-line 
depreciation plus rental cost, with per 
session 
costs 
distributed 
across 
the 
equipment's useful lifetime.  
 Staff time during rTMS sessions 
Active 
Case report forms and provider wage rates 
 Staff time for planning ongoing rTMS 
care and for post-treatment services  
Active 
Provider reports 
 rTMS-related  non-clinical 
administrative staff time 
Active 
Administrative staff reports 
 rTMS-related medical supplies 
Active 
Study investigators and administrative staff 
 rTMS-related electricity expense and 
other overhead 
Active 
Study investigators and administrative staff 
 Office space for rTMS sessions 
Active 
Study investigators and administrative 
staff. Imputed rental cost.  
 rTMS-related computer resource use
Active 
Study investigators and administrative staff 
 Inpatient stays 
Both 
VA administrative HERC cost files 
 All non-rTMS outpatient visits 
Both 
VA administrative HERC cost files 
 Prescription medication 
Both 
DSS pharmacy extracts and Pharmacy 
Benefits Management (PBM) data.  
 
Comparison of HERC & DSS Costs. Data from the VA administrative HERC average 
cost data files will be used to estimate most outpatient and inpatient costs.12-15    The HERC 
average cost data provide cost estimates; the true cost is unknown.  For a second set of cost 
estimates, we will use the VA Decision Support System (DSS).  DSS is a detailed cost 
allocation system that was implemented in 1997 across the VA.  Although DSS is a 
sophisticated accounting tool that taps VA cost and utilization databases for “real time” 
managers’ use, its use by researchers is limited.  Ongoing validation studies with DSS data 
show that the cost estimates need to be carefully reviewed to find administrative errors.  
Because DSS is not standardized nationally, we will use DSS as a secondary source of cost 
and utilization data in a sensitivity analysis.  Recent research compared the HERC and DSS 

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cost estimates, and the research provides guidance on how to use DSS to test the sensitivity of 
the HERC data.16 
Pharmacy Costs. The cost of outpatient prescription medications will come primarily 
from the DSS Pharmacy Extract.  The DSS Pharmacy Extract is a relatively new data source 
that now covers all VA health care systems and medical centers.  The DSS cost includes the 
medication and a dispensing fee that reflects labor and supply costs for the source of the 
prescription, either the VA study sites or the VA centralized mail order pharmacy.  Preliminary 
analysis by VIREC suggests that these data are quite comparable to the VA Pharmacy Benefits 
Management (PBM) data, except that the PBM cost estimate does not include a dispensing fee.   
To verify the completeness and accuracy of DSS prescription records and associated costs, we 
will also access prescription data from the PBM database and compare them to DSS data.  
PBM prescription records could be more complete and accurate in some respects, particularly 
for inpatient stays. DSS inpatient pharmacy records have been aggregated; they contain one 
cost amount per day rather than separate records for each prescription.  Also, we will compare 
PBM to DSS for reporting of diagnostic tests, which could be under-reported in DSS.  Finally, 
we will compare the DSS pharmacy data with the study records on the dispensing of any 
medications to make sure that no double counting occurs. 
2. 
Identification of rTMS Intervention Costs 
The cost of the rTMS intervention will be estimated by aggregating the costs of 
component services and physical resources.  Services costs will be derived from data on 
provider type, service type, and service duration using standard methods.  Providers’ nominal 
earnings will be multiplied by a loading factor (>1) to adjust for fringe benefit and overhead 
costs.  Costs will be assigned to all physical resources, including donated office space and 
computer time, using standard resource valuation methods.  The cost of physical resources 
(e.g., rTMS devices) will include depreciation costs plus the rental cost of capital.  Resource 
prices will be obtained from published sources or will be obtained from VA administrators or 
resource suppliers. 
3.  
rTMS Cost Consequences 
We will estimate the average cost differences between active-rTMS and usual care 
during the acute treatment phase and the follow-up phase.  Two analyses will be conducted, 
one for the period extending 24-weeks post-treatment and one for the period extending 6- to 12-
months post-treatment.  Total average direct and indirect health care costs for all inpatient and  
outpatient care will be included in our estimates.  Will also produce separate estimates by study 
phase (treatment or follow-up), in order to isolate any post-treatment cost-offset effects.  We will 

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collect utilization and cost data from HERC, DSS Pharmacy, PBM, and National Patient Care 
Database (OPC and PTF) files for at least a 30-month period, starting one year prior to the date 
of randomization and extending one year after the end of the treatment follow-up phase.  For 
patients randomized to sham-rTMS, we will assume that health care utilization and costs during 
the post-treatment phase are representative of usual health care utilization and costs for these 
patients. An imputation approach (described in the next paragraph) will be used to estimate their 
cost of usual care during the acute treatment phase.  
Usual Care Costs for Patients Randomized to Sham rTMS. As noted earlier, usual daily 
cost values will be imputed for patients in the comparison group.  Imputation is necessary 
because our cost analysis requires an estimate of the difference between the cost of providing 
rTMS intervention and the cost of providing “usual services over a similar period of potential 
intervention time”.  This “incremental cost” cannot be estimated by the difference in average 
health care costs during the acute treatment phase between the active- and sham-rTMS 
treatment groups.  The estimator for the average incremental cost of rTMS can be expressed as 
E(C | Ta) – E(C | Tu), where C is health care cost, Ta indicates receipt of active rTMS and Tu 
indicates receipt of usual care.  In randomized trials, estimates of the second component of this 
expression, E(C | Tu), are normally calculated as the average cost of care in the comparison 
group.  In this trial that approach is problematic, because this trial will not include a “usual care” 
group, and the sham-rTMS group will potentially get protocol-driven additional days of care as 
compared to the active-rTMS group, if the latter is more effective.   
Instead, we propose to estimate the cost of usual care for the sham-rTMS group during 
the pre-intervention acute treatment phase using HERC estimates of all (inpatient and 
outpatient) VA health care costs during the 6-month period immediately preceding the date of 
study recruitment.  Using these cost estimates, we will calculate each patient’s average 
estimated daily health care cost.  We will multiply these estimated daily cost values by the 
average duration (in days) of the acute treatment phase, measured from first to last day of rTMS 
therapy, among patients randomized to active-rTMS.  The average duration represents the 
expected number of days of usual care that essentially will be foregone as a result of receiving 
active-rTMS.  The product of the average daily health care cost value and the average duration 
will be our imputed value for the usual cost of care in the sham-rTMS treatment group during the 
acute treatment phase of the trial.     
 
Mortality. Mortality information is potentially significant to this economic study because of 
the potential for patients who die to have very high health care costs just prior to expiring.  
Deaths will be identified by searching the VA Patient Treatment File and the VA Beneficiary 

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Identification and Record Locator System (BIRLS) death file.   In sensitivity analyses, all 
analytical findings will be replicated leaving patients who died during the treatment or follow-up 
periods out of the analytical sample. The resulting estimates will be compared with results from 
the complete sample and any differences will be noted in our reporting of the research findings.    
 
Inflation and Discounting. Dollar amounts in the study will be presented in terms of the 
price level as of the last year of data collection.  We will adjust costs for inflation using the 
Consumer Price Index (CPI) for all urban consumers and all goods, the most common measure 
of nationwide inflation.   The CPI is calculated on the basis of a basket of 305 items 
representing all goods and services purchased for everyday living by all urban residents.  We 
will follow standard discounting methods, and discount health benefits and expenditures at a 
rate of 3% per year.1  As noted earlier, HERC cost estimates are adjusted for regional 
differences in health care labor costs.  
 
Discussion of the Rationale for Exclusion of non-VA Costs.  As we noted above, we 
have chosen to limit our economic focus to VA health care costs only.  Clearly, we have the 
opportunity to also collect data on non-VA health care costs.  We recognize that a substantial 
proportion of these CSP 556 study participants’ health care utilization may occur outside the 
VHA system and that it is generally desirable to measure non-VA treatment and caregiver costs.  
However, we believe that the gain in knowledge that could result from an effort to measure non-
VA health care costs does not justify the additional research cost that would be required to 
obtain usable information on non-VA costs.  In particular, we expect that Medicaid 
reimbursements account for a substantial proportion of non-VA expenditures among treatment-
resistant VA patients.  To obtain access to Medicaid data we would need to overcome 
numerous administrative hurdles, including gaining permission from each state’s Medicaid 
agency.  This has become a lengthy and sometimes infeasible process since the 
implementation of HIPAA privacy regulations.  Access to private insurance claims is also 
potentially problematic, and working with claims from numerous private insurance carriers is 
onerous and labor intensive. Medicare files are available for VA patients, but Medicare may 
cover only a handful of patients in this study.  
Estimation of non-VA patient and caregiver indirect costs is also potentially problematic, 
and therefore may not be justifiable given the required added research costs.  Information on  
caregiver costs and patients’ indirect costs is potentially unreliable due to several factors, 
including stigma associated with psychiatric problems and disability, difficult relationships 
between patients and family members, and cognitive problems.  Although it is possible to 
address these issues through careful study planning and thorough data verification steps, the 

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additional expense and the risk that the resulting data would be incomplete and/or unreliable 
suggest that such an enterprise may not be justified in the current study.      
4.   
Cost-Effectiveness Analysis 
The remission outcomes data – where a sustained remission is defined as HRSD<=10 
at 6-weeks post-treatment – will be used in conjunction with incremental treatment cost 
estimates to determine an incremental cost-effectiveness ratio (ICER) for the intervention.  The 
resulting ICER will represent the estimated incremental cost per sustained remission, measured 
at 6-weeks post-treatment.  The ratio will be expressed as: ICER = [E(C | Ta) – E(C | Tu)] / [P(R | 
Ta) – P(R | Tu)], the difference in average acute treatment costs divided by the difference in 
probability of remission (R) between the two groups.  Note that this assumes that the P(R) 
among patients receiving sham-rTMS is approximately equal to the probability of remission 
among usual care patients.  A 95% confidence region surrounding cost-effectiveness ratios will 
be estimated using bootstrapping methods.17-19  
The cost-effectiveness analysis could produce one of three major results: (1) rTMS may 
be cost neutral or less expensive and also more effective than usual depression care, indicating 
that its implementation is highly desirable; (2) rTMS might not be shown clinically effective in the 
VA, in which case its relative cost impact is irrelevant to VA decision-makers;  (3) rTMS therapy 
will be more expensive than sham but will yield a greater likelihood of sustained remission.  In 
this last case, the costs of a sustained remission will be compared with the cost of the main 
alternative treatment option, namely ECT.  Estimates of ECT costs will be derived from the 
literature and from VA administrative sources.4 
5.   
Sensitivity Analyses 
We will test the sensitivity of our results to a number of assumptions.  At a minimum, we 
expect them to include: 
Discount and Inflation Rates.  Costs incurred in earlier years must be inflated over time 
to maintain a steady level of purchasing power.  They must also be inflated over time to reflect 
the discount rate, the rate at which people value money today over the same amount of money 
next year.  The inflation rate, which we will measure by changes in the Consumer Price Index 
(CPI), could be varied in two ways for a sensitivity analysis.  One is to use an alternative  
inflation measure, such as changes in the Gross Domestic Product Implicit Price deflator.  We 
will use the CPI for main analyses and the Gross Domestic Product Implicit Price Deflator in the 
sensitivity analysis.  A second approach is to vary the CPI by a small percentage, such as +/- 
1.0% per year.  Likewise, we will vary the assumed 3% discount rate by using alternative rates, 
such as 2% or 5%.   

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Usual Cost of Care.  We will test our assumption that our imputed average costs in usual 
care for patients randomized to sham-rTMS are typical of treatment-resistant patients with major 
depression by comparing our average costs estimates for this group to a similar group of VA 
patients who are not participating in CSP 556.  We will use Austin OPC-file data patients who 
were screened for participation in the study to estimate a propensity score for treatment-
resistance among patients with a major depression diagnosis.  The propensity score predictors 
will include an algorithm for possible treatment-resistance, which will be based on ICD-9 codes, 
number of changes in antidepressant medications in the past 12 months, treatment with a mood 
stabilizer, receipt of ECT, and other factors identified in extant studies.6, 7, 9, 10 Using this 
propensity score metric, we will identify treatment-resistant likely patients in the VA, and 
estimate their average health care costs and the variance of costs.  Statistics for mean and 
variance will be compared with analogous sample parameters for patients randomized to sham.  
Based on these comparisons, we will define sensitivity ranges and apply them to our cost-
effectiveness and cost-consequences estimates.   
6. 
Power Analysis.   
We do not present power analysis data.  The extant literature provides too little 
information to make such an analysis informative. A key purpose of the cost-consequences 
analyses is to establish potential bounds for cost-offset effects resulting from rTMS, which are a 
necessary component of a power analysis.  Also, the clinical study is adequately powered to 
detect a difference in health outcomes.  We believe that an important finding of the economic 
study will be set of bounds for the potential cost-offsets that are associated with a depression 
remission among treatment-resistant patients with major depression.  Whether or not these 
estimates reach statistical significance at conventional levels, they will provide critical 
information about the potential cost-effectiveness of expanded investment in emerging 
therapeutic technologies for treatment-resistant patients.  They will be useful both in conducting 
future economic evaluation studies using the VA’s large administrative databases as well as in 
ensuring that future cost-effectiveness studies in depression treatment are adequately powered.  
 
E.  Administrative policy 
 
Economics data will be managed in the same way as the clinical data.  We will adopt the 
same procedures and policies developed in the clinical study.   
 
 

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F. Project Coordination and Implementation Plan 
1) Time Frame for Data Collection 
The cost analysis will be conducted throughout the three-year RCT.  The Gantt Chart describing 
the activities and the duration of each is shown below in Table 2. 
Table 2  rTMS for Treatment-Resistant Major Depression Trial – Cost Analysis  
Gantt Chart 
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1.       Establish data collection 
routine at local sites for 
Intervention Costs
2.       Collect cost of production 
data on each subject 
3.       Extract prior- year VHA data 
for each enrolled subject 
4.       Extract post- year VHA data 
for each enrolled subject 
5.       Extract Medicare data for 
those using extensive non-VHA 
services
6.       Analyze the cost of 
Intervention in each Facility
7.       Analyze the healthcare use 
& cost in post-intervention year
8.       Analyze the healthcare use 
& cost in pre- & post-intervention 
years
9.       Analyze the cost-
effectiveness 
10.    Prepare manuscripts, Final 
Report, etc. 
Year 6
Quarter
Quarter
Quarter
Quarter
Quarter
Year 4
Quarter
Year 5
Activity:
Year 1
Year 2
Year 3
 
 
2) Project Plan and Resource Requirements for Cost Analysis 
The Cost Analysis Management Plan for this trial flows from the Gantt Chart of Table 2.  Cost 
analysis will start prospective data collection of primary data collection concerning the 
intervention’s implementation as soon as each site’s IRB approves the study.  In both study 
groups, the prior year of VHA utilization and VHA expenditures will be calculated to establish the 
pre-enrollment healthcare costs per patient and for each group.  For each participant in the trial, 
VHA and Medicare utilization and expenses will be tracked and summarized for 6-months and 
one-year following their treatment follow-up date.  For some portion of the sample, we anticipate 
having more than one-year of follow-up experience recorded in the AAC encounter data, which 
will permit modeling of longer-term impacts.   
 
The cost analysis will be conducted centrally at the Perry Point Cooperative Studies Branch.  
The Investigator time will include: 12.5% of two Health Economists, and 80% of an advanced 
Outcomes Programmer throughout the six-year RCT.  At each site, the primary data 

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collection effort will require 5% of a research coordinator to collect the Intervention’s 
Costs of Implementation.  This allows for the start-up and implementation period and the 
manuscript and final report generation periods in addition to the four-year data collection period 
described above in Table 2. 
a) Investigative Team 
Eric Slade, PhD is a Research Health Scientist at the MIRECC, VAMCS, Baltimore VAMC and 
is an Associate Professor in the Division of Services Research, Department of Psychiatry at the 
University of Maryland School of Medicine.  He will serve as a Health Economist on the 
economic evaluation sub-study.  His participation will require 12.5% FTE each year during the 
project.  This will be Dr. Slade’s first CSP project.  He will collaborate with Dr. Bradham, who is 
on the same campus in the extraction and assembly of the necessary data for the planned 
analyses.  He will assist in the development of the analytical products, manuscripts and final 
reports.  Dr. Slade is currently engaged in numerous studies of mental health service use and 
cost, including several VA projects, and has more than 9 years of post-graduate experience as 
a health economist.   
Douglas D. Bradham, Dr.P.H. is Associate Professor in the Department of Epidemiology and 
Preventive Medicine at the University of Maryland Medical School in Baltimore.  He is a Senior 
CSP Health Economist located at the Perry Point CSP Coordinating Center and at the Baltimore 
VA Medical Center, which is the lead facility in the Veterans Affairs Maryland Health Care 
Systems (VAMHCS).  Dr. Bradham is also the Director of The Capitol Network (VISN 5) HSR&D 
Center, located in the Baltimore-Washington regional area.  His participation will require 12.5% 
FTE each year during the project.  He will: (a) coordinate the extraction of the requisite data 
from the national VHA and Medicare data, and local VHA databases; (b) design the intervention 
cost-identification and healthcare use and expense identification analyses; (c) oversee the cost 
and use analyses; (d) collaborate with other investigators; (e) determine whether the Medicare 
data are warranted and obtain these Medicare data for each of these patient, where informed 
consents allow retrieval; and (f) consult with the Principal Investigators, investigators, data 
coordinators and others necessary to implement the cost analysis study.  He will assist in the 
development of the analytical products, manuscripts and final reports.    
Dr. Bradham has been engaged in the development of this project since the first planning 
meeting on May 9-10, 2005 and is fully committed to its success.  Dr. Bradham has been 
conducting these types of health services impact studies since completing his doctoral work at 
the University of North Carolina in 1981 where he specialized in Health Economics and Health 

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Services Research.  He has been at Baltimore since 1996 developing the infrastructure for HSR 
in VISN 5.  He is an independently-funded investigator for VHA, and has been a member of the 
Scientific Review and Evaluation Boards for HSR&D and RR&D in the VHA.  Dr. Bradham has 
been involved with CSP studies since 2001.   
William J. Culpepper, MS, Ph.D. Candidate (80% FTE) - will provide expertise in: (a) 
extraction of the data from the national VHA and local VHA databases; (b) summarizing the 
intervention’s healthcare use and expense identification process and analyses; (c) analyzing of 
both the cost and use analyses applying the HERC data and techniques; and (d) collaborate in 
the development of the manuscripts and reports.  Mr. Culpepper had 10 years in outcomes 
research before joining Bradham in 2002, where he serves as Assistant Director.  He will 
consult with Local VHA facility IRM personnel and programmers to coordinate and assemble all 
additional data from contributing sites, so that patient-specific event and episode data elements 
are available for the study periods.  He will assist in the development of the analytical products, 
manuscripts and final reports.  He facilitate the extraction the VHA, PBM, DSS and Medicare 
data for these patients and merge them into longitudinal analytic files, in order to prepare the 
final episodic utilization and cost data in a SAS-compatible format, which can be merged with 
other study data.  All healthcare expense estimates will be summarized by setting, (e.g. 
inpatient, outpatient, ER, etc.) and expenditure components, (e.g., pharmacy, physicians, 
laboratory, adverse events) and total healthcare use, allowing for analysis by total and by type 
of setting (ER, ambulatory visit, hospital day, etc.) and by service (Psychiatric, Medical, 
Pharmacy, etc.).   Mr. Culpepper and Dr. Bradham’s staff have assisted Dr. Bradham in similar 
activities over the past three years in health services cost-of-care estimation techniques.  He 
has co-authored manuscripts with Dr. Bradham.   
b) Budget Justification: 
Drs. Bradham and Slade are VHA employees and the portion of their VHA salary levels are 
used to estimate the budget requirements.  Mr. Culpepper is a University of Maryland employee.  
His time will be acquired by IPA arrangement with the Department of Epidemiology and 
Preventive Medicine, where Dr. Bradham is his supervisor.  The analytical work will be 
accomplished through the facilities at the Perry Point Coordinating Center and Dr. Bradham’s 
offices at the University of Maryland, Department of Epidemiology and Preventive Medicine 
based on a Memorandum of Understanding.   
Travel expenses are needed for all three Health Economics Investigators to attend the annual 
meeting for the trial, and for at least one professional meeting – the latter has been included in 

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the budget.  Specialized computer expenses are anticipated to be consistent with VA Data 
Security Policy.  Software updates are required for all three investigators bi-annually.    

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References 
 
1. Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-Effectiveness in Health and 
Medicine. Oxford: Oxford University Press; 1996. 
 
2. Swindle R, Lukas CV, Meyer DA, Barnett PG, Hendricks AM. Cost analysis in the department 
of veterans affairs: Consensus and future directions. Med Care. 1999;37:AS3-8. 
 
3. Berndt ER, Bir A, Busch SH, Frank RG, Normand SL. The medical treatment of depression, 
1991-1996: Productive inefficiency, expected outcome variations, and price indexes. J Health 
Econ. 2002;21:373-396. 
 
4. Kozel FA, George MS, Simpson KN. Decision analysis of the cost-effectiveness of repetitive 
transcranial magnetic stimulation versus electroconvulsive therapy for treatment of nonpsychotic 
severe depression. CNS Spectr. 2004;9:476-482. 
 
5. Blow FC, Owen RE, eds. Specialty Care for Veterans with Depression in the VHA: 2002 
National Registry for Depression (NARDEP) Project Report. Ann Arbor, MI: Serious Mental 
Illness Treatment Research and Evaluation Center; 2003. 
 
6. Corey-Lisle PK, Birnbaum HG, Greenberg PE, Marynchenko MB, Claxton AJ. Identification of 
a claims data "signature" and economic consequences for treatment-resistant depression. J Clin 
Psychiatry. 2002;63:717-726. 
 
7. Crown WH, Finkelstein S, Berndt ER, et al. The impact of treatment-resistant depression on 
health care utilization and costs. J Clin Psychiatry. 2002;63:963-971. 
 
8. Thase ME. New approaches to managing difficult-to-treat depressions. J Clin Psychiatry. 
2003;64 Suppl 1:3-4. 
 
9. Kornstein SG, Schneider RK. Clinical features of treatment-resistant depression. J Clin 
Psych. 2001;62:18-25. 
 
10. Greenberg P, Corey-Lisle PK, Birnbaum H, Marynchenko M, Claxton A. Economic 
implications of treatment-resistant depression among employees. Pharmacoeconomics. 
2004;22:363-373. 
 
11. Russell JM, Hawkins K, Ozminkowski RJ, et al. The cost consequences of treatment-
resistant depression. J Clin Psychiatry. 2004;65:341-347. 
 
12. Phibbs CS, Bhandari A, Yu W, Barnett PG. Estimating the costs of VA ambulatory care. 
Med Care Res Rev. 2003;60(3 suppl.):54S-73S. 
 
13. Yu W, Wagner TH, Chen S, Barnett PG. Average cost of VA rehabilitation, mental health, 
and long-term hospital stays. Med Care Res Rev. 2003;60:40S-53S. 
14. Wagner TH, Chen S, Barnett PG. Using average cost methods to estimate encounter-level 
costs for medical-surgical stays in the VA. Med Care Res Rev. 2003;60:15S-36S. 
 
 

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15. Smith MW, Joseph GJ.  
Pharmacy data in the VA health care system. Med Care Res Rev. 2003;60(3):92S-123S. 
16. Wagner TH, Velez J. A comparison of inpatient costs from the HERC and DSS national data 
extract datasets. Menlo Park, CA: VA Health Economics Resource Center; 2004. 
17. Willan AR, O'Brien BJ. Sample size and power issues in estimating incremental cost-
effectiveness ratios from clinical trials data. Health Econ. 1999;8:203-211. 
18. O'Brien BJ, Drummond MF, Labelle RJ, Willan A. In search of power and significance: 
Issues in the design and analysis of stochastic cost-effectiveness studies in health care. Med 
Care. 1994;32:150-163. 
19. Stinnett AA, Mullahy J. Net health benefits: A new framework for the analysis of uncertainty 
in cost-effectiveness analysis. Med Decis Making. 1998;18:S68-80. 
 
 
 

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Attachment 1:   Study Intervention’s Implementation Costs 
  
 

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The purpose of this form is to help you track the local expenses and resources used developing, 
testing, implementing and maintaining the Study’s Intervention.  Ideally, one form should be 
filed per month, even if there is no activity.   
1. 
Site __ __ __ 
 
2. 
Date  __ __ / __ __ / __ __ __ __  Please enter Date of Submission as mm/dd/yyyy 
 
3. 
Please list all Study meetings where the Intervention was discussed, by date (3.a), since 
last report.   
Classify by entering a check mark the following characteristics about the meeting: 3.b. purpose 
(i.e., Development, Implementation, Maintenance) and 3.c. mode of meeting, (i.e., Telephone, 
Face-to-face or Video).   
 
Record in 3.d. the total number of persons in attendance.  For each personnel category attending 
(3.e.) indicate personnel grade (i.e., GS or Title 38, and level).   
 
Finally, in 3.f., indicate approximate total time involved and the types of activity (3.g.), (i.e., 
Preparation, Conduct and Follow-up).   
Example:  A telephone conference attended by 5 people.  Three are MDs (T38); one is NP (T38) 
and one is PhD researcher (GS-13).  Total time for the meeting was 1 hour, but approximately 
1.5 hours was spent by two attendees in preparation and 1 hour in follow-up to prior meeting.     
 
Mtg
. # 
Date 
Purpose 
Mode of 
Meeting 
Total # 
@ Mtg. 
Personnel 
Grade 
Time 
Involved 
Type of 
Activity 
 
(mm/dd/yyyy
) 
D I M T
F
V
 
GS 
T38 
Hr 
Mi
n 
P
C
F
I 
02/03/2004 
X 
 
 
X
 
 
5 
2@11 2@NII
I 
3 
30 
X
X
X
 
 
 
3.a. 
3.b. 
3.c. 
3.d. 
3.e. 
3.f. 
3.g. 
Mt
g. # 
Date 
Purpose 
Mode of 
Meeting 
Total # 
@ Mtg. 
Personnel 
Grade  
(# @ Grade)
Time 
Involved 
Type of 
Activity 
 
(mm/dd/yyyy) D I M T 
F 
V
 
GS 
T38 
Hr 
Min
P 
C
F 
I 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
II 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IV 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
V 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VII 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VII
I 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. 
Please list all Equipment or Space required for the Intervention purchased or 
encumbered since last report.  
In 4.a. please indicate date of purchase (or date of encumbrance). 
In 4.b. please describe the equipment item by model name or number.  If space allocated to 
intervention, then indicate room # and total square feet.   
In 4.c. please describe the role of the equipment or space in the intervention, e.g., primary 
intervention, or patient safety, or sub-hypothesis, or covariate (e.g., “metabolic cart is for nutrition 
status, a covariate”).  If uncertain of these categories, then indicate briefly in “other” column.   
In 4.d. indicate the amount expended.  If contributed, enter 88888.   
 
 
4.a. 
4.b. 
4.c. 
4.d. 
Check 
Equip.(E) 
or 
Space (S) 
Date 
Item 
Purpose 
Dollar 
Amount 
(mm/dd/yyyy) 
Brief description or 
model # 
Role of item in the intervention, 
e.g., primary intervention, or 
patient safety, or sub-hypothesis, or 
covariate – or explain. 
(no decimals, 
please) 
# 
E? 
S? 
mm 
dd 
yyyy 
Model # or Room # 
PI 
PS 
SH 
C 
Other? 
 
I 
 
 
 
 
 
 
 
 
 
 
 
 
II 
 
 
 
 
 
 
 
 
 
 
 
 
III 
 
 
 
 
 
 
 
 
 
 
 
 
IV 
 
 
 
 
 
 
 
 
 
 
 
 
V 
 
 
 
 
 
 
 
 
 
 
 
 
VI 
 
 
 
 
 
 
 
 
 
 
 
 
VII 
 
 
 
 
 
 
 
 
 
 
 
 
VII
I 
 
 
 
 
 
 
 
 
 
 
 
 
IX 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 

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5. 
Please list all Materials or Supplies required for the Intervention purchased or 
encumbered since last report.  Please indicate the number of patients to be served – 
approximately; (e.g., 1,000 4X4 bandages should serve ?? patients).   
In 5.a. please indicate date of purchase (or date of encumbrance). 
In 5.b. please describe the equipment item by order or supply number.  
In 5.c. please describe the role of the item in the intervention, e.g., primary intervention, or patient 
safety, or sub-hypothesis, or covariate (e.g., “metabolic cart is for nutrition status, a covariate”).  If 
uncertain of these categories, then indicate briefly in “other” column.   
In 5.d. indicate the amount expended.  If contributed, enter 88888.   
 
 
5.a. 
5.b. 
5.c. 
5.d. 
Check 
Everyone.(E) 
Or only 
Some (S) 
Date 
Item 
Purpose 
Dollar 
Amount 
(mm/dd/yyyy) 
Brief description or 
model # 
Role of item in the intervention, e.g., 
primary intervention, or patient 
safety, or sub-hypothesis, or covariate 
– or explain. 
(no 
decimals, 
please) 
# 
Number 
of 
Patients 
to be 
served 
mm 
dd 
yyyy 
Order # or Supply # 
PI 
PS 
SH 
C 
Other? 
 
I 
 
 
 
 
 
 
 
 
 
 
 
II 
 
 
 
 
 
 
 
 
 
 
 
III 
 
 
 
 
 
 
 
 
 
 
 
IV 
 
 
 
 
 
 
 
 
 
 
 
V 
 
 
 
 
 
 
 
 
 
 
 
VI 
 
 
 
 
 
 
 
 
 
 
 
VII 
 
 
 
 
 
 
 
 
 
 
 
VIII 
 
 
 
 
 
 
 
 
 
 
 
IX 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please fax this form back to the Coordinating Center at 410 – XXX-XXXX. 
File the original with your Study records so you can answer questions if we need to call you 
about an item.   
 
Thank you for your assistance. 
 
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-32 
 
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-33 
Current VHA Target Population 
 
The VHA’s clinical management operational data system, the Decision Support System (DSS), 
indicates that in 2005 approximately 130,193 veterans had received inpatient or outpatient care 
where their primary or principal diagnosis was “Depression”, and had other mental health 
comorbidities, including: Dementia (12%), Schizophrenia (24%), Bipolar Disorder (23%), 
Anxiety (56%), PTSD (49%), Substance Abuse (66%), or Brain Injury (3%).  These patients’ 
condition demand considerable resources from the VHA, with all being hospitalized at least once 
per year, 9,744 (7%) being admitted three or more times annually, and 11,464 (11%) visiting the 
VHA ER three or more times per year.  The combination of services provided to this population 
results in 9,676 (7%) of this comorbid Depression population receiving care valued above 
$75,000 per year.  The overall total expenditure from VHA for this population amounted to more 
than $4.1 billion in 2005.   
 
 
Potential Target Sampling Pool at Participating VHA Sites 
 
Analysis of the DSS data for the entire patient caseload with Depression as a primary or principal 
diagnosis in either inpatient or outpatient care found that approximately 48,063 patients met this 
criterion in 2005.  Of these, an estimated 21,663 were between the ages of 18 and 70, inclusively.  
As shown in Table ??, 228 also had Dementia and Brian Injury diagnoses during the year, with 8 
having both.  Since these secondary conditions would exclude them from recruitment to the 
trial’s protocol, approximately 21,443 would be eligible for this protocol, nationally.  This 
becomes the population to which the trial could generalize.  This clinical population accounted 
for $161.3 million in 2005 VHA expenditures for inpatient care and outpatient encounters and 
pharmacy.   
 
For the ten sites being considered, approximately 4,140 unique patients would be both eligible 
and within the age range of 18 to 70.  Portions of this patient population have been seen for 
mental health comorbidities during the same year: Substance Abuse (19 %), PTSD (24 %), 
Anxiety (14 %), Bipolar Disorder (8 %) and Schizophrenia (6 %).  These clinical incidence rates 
are consistent with those found in the overall population of 21,443: Substance Abuse (21 %), 
PTSD (22 %), Anxiety (14 %), Bipolar Disorder (9 %) and Schizophrenia (7 %), suggesting that 
these potential CSP 556 sites could render generalizable findings.   
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-19 
NATION
12
130,193
15,336
31,789
30,150
73,270
63,539
85,701
3,531
1
12
6,395
839
1,614
1,842
3,808
3,842
4,381
226
2
12
3,988
505
1,072
1,055
2,555
2,368
2,814
114
3
12
4,878
568
1,654
1,317
2,855
2,821
3,324
92
4
12
7,002
709
1,743
1,941
4,153
3,683
4,817
174
5
12
4,744
610
1,395
1,306
2,851
2,827
3,350
136
6
12
8,322
835
1,827
1,652
4,789
4,141
5,398
197
7
12
8,502
905
2,488
1,835
5,103
4,469
5,731
232
8
12
12,542
1,651
3,183
3,296
7,096
5,729
7,751
350
9
12
8,577
920
1,793
2,004
5,006
3,960
5,515
162
10
12
6,534
789
1,837
1,783
3,990
3,450
4,735
148
11
12
6,036
603
1,487
1,371
3,388
2,822
4,230
135
12
12
6,267
734
1,744
1,665
3,779
3,090
4,545
161
15
12
6,684
831
1,661
1,644
4,001
3,095
4,527
197
16
12
13,176
1,348
3,222
2,507
7,222
5,867
8,853
347
17
12
7,699
898
1,907
1,698
4,055
3,805
4,928
139
18
12
7,280
920
1,686
1,746
4,174
3,738
4,679
334
19
12
4,778
453
1,010
1,313
2,685
2,369
2,994
137
20
12
7,166
795
1,538
1,624
4,016
3,969
4,803
182
21
12
6,106
843
1,517
1,522
3,315
3,223
3,897
222
22
12
7,149
753
1,931
1,898
3,924
3,322
4,581
170
23
12
7,621
987
1,547
1,772
4,267
3,484
5,068
343
PTSD
Substance 
Abuse
Mental 
Disorder 
due to Brain 
Damage
Total Unique SSNs
Other Diagnosis and Co Morbidity List
VISN
MONTHS
All VHA 
Depression 
Past 4 QTRS
Dementia
Schizophrenia
Bi Polar
Anxiety, 
Personality 
Disorder
 
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-20 
NATION
12
130,193
11,464
9,744
15,246
7,435
9,676
130,193
21,522
2,546,324,129
4,152,226,250
1
12
6,395
286
687
419
245
688
6,395
1,297
147,598,947
243,629,275
2
12
3,988
634
375
645
413
331
3,988
804
79,538,114
137,350,214
3
12
4,878
330
552
495
322
866
4,878
926
132,236,801
233,156,299
4
12
7,002
426
706
717
354
625
7,002
1,227
144,422,564
251,104,922
5
12
4,744
339
533
550
398
475
4,744
895
101,816,016
173,558,642
6
12
8,322
1,099
571
1,342
711
465
8,322
1,376
150,741,866
244,973,705
7
12
8,502
540
539
896
424
544
8,502
1,255
159,195,565
261,898,897
8
12
12,542
1,280
881
1,979
1,017
819
12,542
2,216
239,657,231
380,702,979
9
12
8,577
1,444
507
1,704
932
484
8,577
1,475
150,871,606
241,739,792
10
12
6,534
110
857
182
129
587
6,534
1,573
134,389,222
227,089,462
11
12
6,036
478
488
611
234
405
6,036
940
116,099,765
189,630,665
12
12
6,267
712
542
819
642
638
6,267
1,257
142,299,536
231,046,112
15
12
6,684
736
558
1,150
633
365
6,684
1,100
117,307,903
191,701,371
16
12
13,176
1,804
826
2,020
991
800
13,176
2,138
237,709,289
379,907,803
17
12
7,699
603
659
1,017
436
506
7,699
1,514
144,758,344
226,520,975
18
12
7,280
607
537
694
373
338
7,280
1,172
122,816,706
195,432,493
19
12
4,778
457
349
378
203
351
4,778
739
94,589,301
152,560,215
20
12
7,166
194
517
292
165
446
7,166
1,036
137,177,570
219,482,459
21
12
6,106
610
515
709
372
769
6,106
1,089
154,810,596
253,891,661
22
12
7,149
872
405
1,150
604
739
7,149
1,105
158,345,375
268,138,450
23
12
7,621
139
743
224
148
648
7,621
1,278
170,874,112
263,604,565
3 Or More 
ED Visits
Patients with 
1 or more 
Discharges in 
Past 4 QTRS
Re-Admit 
Within 30 
Days
Total Direct 
Cost Of Care 
For Patients 
With At Least 
1 Co-Morbid 
Condition
Total Actual 
Cost Of Care 
For Patients 
With At Least 
1 Co-Morbid 
Condition
3 Or More 
Inpat Admits
Combo 3 Or 
More ED 
Visits And 
Inpat Admits
Total 3 Or 
More ED 
Visits And 3 
Or More 
Inpat Admits
Total Actual 
Cost Of 
Care 
$75,000 Or 
Greater
Total Unique SSNs
High Risk And High Cost Unique SSNs
VISN
MONTHS
All VHA 
Depression 
Past 4 QTRS
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-19 
 
Total
Brain Inj.
Dementia
D & B Inj
VISN - FACILITY - Location
No
18 to 70
All Ages
Yes
Yes
BOTH
7 - 509 - AUGUSTA
Unique Patients Using VHA 
54
462
574
0
6
0
456
% within Station
9.40%
100.00%
100.00%
0.00%
1.30%
0.00%
% within Age of 18 to 70
0.90%
2.10%
1.20%
0.00%
3.30%
0.00%
1 - 518 - BEDFORD
Unique Patients Using VHA 
23
63
209
0
0
0
63
% within Station
11.00%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
0.40%
0.30%
0.40%
0.00%
0.00%
0.00%
2 - 528 - BUFFALO
Unique Patients Using VHA 
168
986
1,298
0
8
0
978
% within Station
12.90%
100.00%
100.00%
0.00%
0.80%
0.00%
% within Age of 18 to 70
2.70%
4.60%
2.70%
0.00%
4.40%
0.00%
7 - 534 - CHARLESTON
Unique Patients Using VHA 
15
162
192
0
0
0
162
% within Station
7.80%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
0.20%
0.70%
0.40%
0.00%
0.00%
0.00%
10 - 539 - CINCINNATI
Unique Patients Using VHA 
159
155
1,368
0
1
0
154
% within Station
11.60%
100.00%
100.00%
0.00%
0.60%
0.00%
% within Age of 18 to 70
2.60%
0.70%
2.80%
0.00%
0.50%
0.00%
19 - 554 - DENVER
Unique Patients Using VHA 
53
190
545
1
2
0
187
% within Station
9.70%
100.00%
100.00%
0.50%
1.10%
0.00%
% within Age of 18 to 70
0.90%
0.90%
1.10%
2.20%
1.10%
0.00%
6 - 558 - DURHAM
Unique Patients Using VHA 
404
510
4,047
1
7
0
502
% within Station
10.00%
100.00%
100.00%
0.20%
1.40%
0.00%
% within Age of 18 to 70
6.60%
2.40%
8.40%
2.20%
3.80%
0.00%
12 - 578 - HINES
Unique Patients Using VHA 
290
119
1,635
1
0
0
118
% within Station
17.70%
100.00%
100.00%
0.80%
0.00%
0.00%
% within Age of 18 to 70
4.70%
0.50%
3.40%
2.20%
0.00%
0.00%
16 - 580BY - HOUSTON - BEAUMONT OUTPATIENT CLINICUnique Patients Using VHA 
135
586
1,425
1
4
0
581
% within Station
9.50%
100.00%
100.00%
0.20%
0.70%
0.00%
% within Age of 18 to 70
2.20%
2.70%
3.00%
2.20%
2.20%
0.00%
16 - 598 - LITTLE ROCK
Unique Patients Using VHA 
66
133
465
0
0
0
133
% within Station
14.20%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
1.10%
0.60%
1.00%
0.00%
0.00%
0.00%
21 - 640 - PALO ALTO
Unique Patients Using VHA 
19
74
280
0
0
0
74
% within Station
6.80%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
0.30%
0.30%
0.60%
0.00%
0.00%
0.00%
4 - 646 - PITTSBURGH(UD)
Unique Patients Using VHA 
34
225
271
1
4
1
221
% within Station
12.50%
100.00%
100.00%
0.40%
1.80%
0.40%
% within Age of 18 to 70
0.60%
1.00%
0.60%
2.20%
2.20%
12.50%
19 - 660 - SALT LAKE CITY
Unique Patients Using VHA 
6
62
80
0
1
0
61
% within Station
7.50%
100.00%
100.00%
0.00%
1.60%
0.00%
% within Age of 18 to 70
0.10%
0.30%
0.20%
0.00%
0.50%
0.00%
21 - 662 - SAN FRANCISCO
Unique Patients Using VHA 
73
43
118
0
0
0
43
% within Station
61.90%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
1.20%
0.20%
0.20%
0.00%
0.00%
0.00%
20 - 663 - SEATTLE
Unique Patients Using VHA 
48
151
584
1
0
0
150
% within Station
8.20%
100.00%
100.00%
0.70%
0.00%
0.00%
% within Age of 18 to 70
0.80%
0.70%
1.20%
2.20%
0.00%
0.00%
8 - 672 - SAN JUAN
Unique Patients Using VHA 
12
98
117
0
0
0
98
% within Station
10.30%
100.00%
100.00%
0.00%
0.00%
0.00%
% within Age of 18 to 70
0.20%
0.50%
0.20%
0.00%
0.00%
0.00%
1 - 689 - WEST HAVEN
Unique Patients Using VHA 
209
161
412
0
2
0
159
% within Station
50.70%
100.00%
100.00%
0.00%
1.20%
0.00%
% within Age of 18 to 70
3.40%
0.70%
0.90%
0.00%
1.10%
0.00%
CSP 556 POTENTIAL SITES
4,180
13,620
4,140
ALL OTHER VHA SITES
Unique Patients Using VHA Care in 200
17,593
34,552
41
149
8
17,303
Total
6121
21,663
48,063
46
182
8
21,443
% within Age of 18 to 70
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
% of Total
12.70%
100.00%
100.00%
0.20%
0.80%
0.00%
When Age is 18 to 70 
Unique Patients with Prime or Principal Diagnosis as "Depression" 
in either Inpatient or Outpatient VHA Care 
g
for CSP 
556
EXCLUSIONS:
 

_____________________________________________________ 
CSP #556, ”The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix M, Health Economics and Cost Analysis 
 
M-20 
SEX
 
Subs Ab
PTSD
Anxiety
BiPolar
Schiz.
VISN - FACILITY - Location
Yes
Yes
Yes
Yes
Yes
Female
7 - 509 - AUGUSTA
456
114
146
73
35
44
85
24.70%
31.60%
15.80%
7.60%
9.50%
18.40%
2.60%
3.10%
2.40%
1.90%
3.20%
2.50%
1 - 518 - BEDFORD
63
18
18
10
11
3
6
28.60%
28.60%
15.90%
17.50%
4.80%
9.50%
0.40%
0.40%
0.30%
0.60%
0.20%
0.20%
2 - 528 - BUFFALO
978
135
237
182
58
54
162
13.70%
24.00%
18.50%
5.90%
5.50%
16.40%
3.10%
5.00%
6.00%
3.20%
4.00%
4.70%
7 - 534 - CHARLESTON
162
29
42
27
10
8
28
17.90%
25.90%
16.70%
6.20%
4.90%
17.30%
0.70%
0.90%
0.90%
0.50%
0.60%
0.80%
10 - 539 - CINCINNATI
154
41
31
17
15
7
29
26.50%
20.00%
11.00%
9.70%
4.50%
18.70%
0.90%
0.70%
0.60%
0.80%
0.50%
0.80%
19 - 554 - DENVER
187
79
59
22
35
17
19
41.60%
31.10%
11.60%
18.40%
8.90%
10.00%
1.80%
1.20%
0.70%
1.90%
1.20%
0.60%
6 - 558 - DURHAM
502
88
135
71
39
21
101
17.30%
26.50%
13.90%
7.60%
4.10%
19.80%
2.00%
2.80%
2.30%
2.10%
1.50%
2.90%
12 - 578 - HINES
118
31
26
18
15
7
15
26.10%
21.80%
15.10%
12.60%
5.90%
12.60%
0.70%
0.50%
0.60%
0.80%
0.50%
0.40%
16 - 580BY - HOUSTON - BEAUMONT OUTPATIENT CLINIC'
581
102
88
52
26
32
85
17.40%
15.00%
8.90%
4.40%
5.50%
14.50%
2.30%
1.90%
1.70%
1.40%
2.30%
2.50%
16 - 598 - LITTLE ROCK
133
39
46
22
10
9
17
29.30%
34.60%
16.50%
7.50%
6.80%
12.80%
0.90%
1.00%
0.70%
0.50%
0.70%
0.50%
21 - 640 - PALO ALTO
74
30
26
19
9
2
10
40.50%
35.10%
25.70%
12.20%
2.70%
13.50%
0.70%
0.50%
0.60%
0.50%
0.10%
0.30%
4 - 646 - PITTSBURGH(UD)
221
24
25
16
23
6
42
10.70%
11.10%
7.10%
10.20%
2.70%
18.70%
0.50%
0.50%
0.50%
1.30%
0.40%
1.20%
19 - 660 - SALT LAKE CITY
61
12
19
14
11
7
11
19.40%
30.60%
22.60%
17.70%
11.30%
17.70%
0.30%
0.40%
0.50%
0.60%
0.50%
0.30%
21 - 662 - SAN FRANCISCO
43
2
3
0
1
1
1
4.70%
7.00%
0.00%
2.30%
2.30%
2.30%
0.00%
0.10%
0.00%
0.10%
0.10%
0.00%
20 - 663 - SEATTLE
150
25
43
14
11
9
21
16.60%
28.50%
9.30%
7.30%
6.00%
13.90%
0.60%
0.90%
0.50%
0.60%
0.70%
0.60%
8 - 672 - SAN JUAN
98
4
15
13
3
5
12
4.10%
15.30%
13.30%
3.10%
5.10%
12.20%
0.10%
0.30%
0.40%
0.20%
0.40%
0.30%
1 - 689 - WEST HAVEN
159
18
36
23
16
10
21
11.20%
22.40%
14.30%
9.90%
6.20%
13.00%
0.40%
0.80%
0.80%
0.90%
0.70%
0.60%
CSP 556 POTENTIAL SITES
4,140
791
995
593
328
242
665
19%
24%
14%
8%
6%
16%
ALL OTHER VHA SITES
17,303
3,612
3,771
2,479
1,514
1,131
2,793
21%
22%
14%
9%
7%
16%
21,443
4,380
4,742
3,056
1,832
1,366
3,441
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
20.20%
21.90%
14.10%
8.50%
6.30%
15.90%
Eligible 18 to 70 Year Old Patient's 
Other Mental Health Comorbidities 
Unique Patients with Prime or Principal 
Diagnosis as "Depression" 
g
for CSP 
556
 
 

 
 
APPENDIX N 
 
 
LIST OF POTENTIAL PARTICIPATING SITES 
AND LIKELY PATIENT POPULATIONS 
 
 

_____________________________________________________ 
CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013  
Appendix N, Selected Sites 
N-1 
 
APPENDIX N:  LIST OF POTENTIAL PARTICIPATING SITES  
 
 
 
SITE NAME 
Palo Alto, CA  
Charleston, SC 
Salt Lake City, UT 
Philadelphia, PA 
Cincinnati, OH 
Pittsburgh, PA 
Temple, TX 
San Francisco, CA 
White River Junction, VT 
 

 
 

 
 
 
 
APPENDIX O 
 
 
TMS TRAINING AND CERTIFICATION 
 
 
 
 
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix O, TMS Training and Certification 
O-1 
 
 
Proper training and supervision and oversight of TMS operators are very important for both 
safety and probably efficacy. We will institute, without question, the most rigorous training 
and certification process of any TMS multi-site trial ever. This is an important aspect of this 
trial as we will be having registered nurses, nurse practitioners, or physician assistants 
performing the large majority of treatments, under the close supervision of licensed and 
trained psychiatrists or neurologists who are also trained in rTMS. These physicians have 
experience caring for patients with major depressive disorder, and most have experience 
conducting rTMS clinical trials. The daily treatments take about an hour in terms to prepare 
the patient, answer questions about safety and their condition, and conduct the actual 
treatment. Having MDs perform these treatments would make TMS prohibitively expensive 
for most patients, and for the VA medical system.  
Thus, during this study we will develop training and quality methods not only for the MDs 
who will be doing the treatments, but also for the registered nurses, nurse practitioners, and 
physician assistants administrating the treatment. The training curriculum and certification 
will be developed and overseen by Mark George, M.D and David Avery, M.D., leading TMS 
experts and researchers. The TMS training and certification process used in this trial will 
take advantage of the knowledge gained from the conduct of the recent NIH Optimization of 
Transcranial Magnetic Stimulation for Depression (OPT-TMS) trial, the Neuronetics-
sponsored multisite trial of TMS in depression, knowledge gained with the recent FDA 
approval of TMS and the need to train psychiatrists across the country regarding proper 
TMS technique, and workshops and seminars on TMS use conducted over the past few 
years at the annual meeting of the American Psychiatric Association.   
The physicians who will be supervising and prescribing TMS are all VA psychiatrists or 
neurologists, licensed and credentialed in their respective states and with VA clinical 
privileges. An important concept of the trial is that these physicians will be responsible for 
each TMS session. In the OPT-TMS trial, most sites had more than one TMS certified 
physician, in order to cover TMS delivery when a physician was out of town, sick, or on 
vacation.  
The certification process for the MDs, RNs, RNPs, and PAs will start before the kickoff 
meeting, and there will be ongoing recertification as well as the potential for new certification 
of MDs throughout the trial, as personnel change and move away from a VA. Prior to the 
first kickoff meeting, candidate study staff will receive pre-reading materials. The training will 
involve pre-reading materials including the safety paper (Rossi, Hallett et al. 2009) and the 
curriculum from the APA TMS course. There will be lectures at the kickoff meeting and a 
written test which will include testing on how to handle safety issues including what to do if 
there is a TMS induced seizure. This will be followed by hands-on testing of how to operate 
the TMS machines, find the motor area, determine the motor threshold, find the treatment 
area, and deliver the treatment. The TMS device manufacturer will be available at the 
meeting and at the time of device set-up at the site to provide a cursory overview of the 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix O, TMS Training and Certification 
O-2 
 
device. The curriculum for the MD training has been adopted from a course prepared by Dr. 
George and Dr. Ziad Nahas which has been given each year at the American Psychiatric 
Association, and which will also be given this year at the annual meeting of the Association 
for Convulsive Therapy (see course outline below). Each certified MD, RN, RNP, and PA will 
have to pass the written test and a hands-on skill course at this meeting in order for the site 
to launch.  We will also be offering this series periodically through the life of the trial either at 
the Ralph H. Johnson VA Medical Center in Charleston or online or at other venues in order 
to train and certify secondary MDs, and to handle personnel changes at sites. TMS training 
and certification for the CSP 556 study will be conducted at the site, using a combination of 
written materials, PowerPoint slides, videos, hands-on by currently study-certified staff, a 
written exam, and a video conference with Dr. Mark George. Importantly, all TMS treatments 
in this study will be supervised by these TMS-certified MDs and administered by the TMS-
certified RNs, RNPs, and PAs. This approach is entirely consistent with the recent safety 
consensus paper and with clinical delivery of TMS in the US community. Because the MDs 
will be responsible for determining the initial motor threshold and finding the treatment scalp 
location, the training will focus more on correctly monitoring patients during treatment 
sessions, safety issues in terms of seizures or syncopes, and how to safely interrupt 
treatments. There will also be vignettes of different patient emergencies and how to handle 
them (e.g. fire alarm, patient discomfort, power interruption, device malfunction, etc.). This 
initial series of training, certification and constant monitoring was developed by Dr. George 
and Dr. Nahas and was used in the industry sponsored trial and the recently completed NIH 
sponsored TMS depression trial.  
In addition to this rigorous initial training, we will have periodic re-assessments of skills at 
the annual investigators meetings, and will have on-site testing by Dr. George or other 
members of the certifying and quality assessment group. Dr. George has designed a 
phantom head with a small pickup coil inside it that can be used to test the skill level of TMS 
operators. The TMS vendor has built this phantom and it will be beta-tested before the 
annual meeting and then potentially used as a mannequin or dummy for certification and 
recertification. This phantom can be used at yearly meetings or carried to sites to make sure 
that operators can reliably and accurately determine the proper motor area and motor 
threshold.  
If an MD, RN, RNP, or PA fail the initial written test they will be allowed to retake it only two 
more times, and then will be deemed ineligible and the site will have to put forward other 
candidates. The same will apply for the hands-on skill testing.  
Should this CSP study find evidence of TMS efficacy and safety in the depressed VA 
population, the lessons learned in this study regarding proper training and certification, and 
the curriculum and methods developed, will likely serve as the building block for how the VA 
might adopt the technology as a treatment and insure safe and qualified use of TMS.  
Rossi, S., M. Hallett, et al. (2009). "Safety, ethical considerations, and application guidelines 
for the use of transcranial magnetic stimulation in clinical practice and research." Clin 
Neurophysiol 120(12): 2008-2039. 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix O, TMS Training and Certification 
O-3 
 
 
 
 
 
Certificate course on TMS 
 
Table of contents 
 
1. How TMS works- Mechanisms of action of TMS 
2. Safety in TMS: Potential side effects and their management 
3. Regulations and policies concerning TMS 
4. TMS efficacy in major depressive disorder 
5. Practical topics in clinical TMS management 
6. How to set up and staff a TMS service 
7. Use of the MagPro30 device and components 
8. Obtaining motor threshold 
9. Administrating TMS 
10. Practicum sessions and testing 
11. Written exam 
 
 
See next page 
 
 
 
 
 
 
 
 
 
 
 
 
 

CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” 
Version 4.0, September 2013 
Appendix O, TMS Training and Certification 
O-4 
 
 
 
 
 
 
 
 
 
Cooperative Studies Program #556 
Certificate of completion 
The Executive Committee of CSP #556 certifies that on (date) 
 (Name) 
Attended the certificate course in Transcranial Magnetic Stimulation and 
successfully passed the course examination. This didactic and practicum 
course included review of selection and preparation, TMS technique, 
management of complications, TMS treatment management and 
medicolegal issues. A one hour written examination tested the theoretical 
and practical knowledge learned in the course 
  
 
 
 
 
 
  
Jerome Yesavage, MD    
 
                        Mark George, MD 
               Chairman, CSP #556 

 
 
SAFETY PLAN: VA VERSION 
Step 1: Warning signs: 
1. 
_____________________________________________________________ 
2. 
_____________________________________________________________ 
3. 
_____________________________________________________________ 
Step 2: Internal coping strategies - Things I can do to take my mind off my problems 
without contacting another person: 
1.  
_____________________________________________________________ 
2. 
_____________________________________________________________ 
3. 
_____________________________________________________________ 
Step 3: People and social settings that provide distraction:   
1. 
Name_________________________________ Phone____________________ 
2. 
Name_________________________________ Phone____________________ 
3. 
Place________________________   4. Place  __________________________ 
Step 4: People whom I can ask for help:  
1. 
Name_________________________________ Phone____________________ 
2. 
Name_________________________________ Phone____________________ 
3. 
Name_________________________________ Phone____________________ 
Step 5:Professionals or agencies I can contact during a crisis:  
1. 
Clinician Name__________________________ Phone____________________ 
 
Clinician Pager or Emergency Contact #________________________________ 
2. 
Clinician Name__________________________ Phone____________________ 
 
Clinician Pager or Emergency Contact #________________________________ 
3. 
Local Urgent Care Services _________________________________________ 
 
Urgent Care Services  Address_______________________________________ 
 
Urgent Care Services  Phone ________________________________________ 
4. 
VA Suicide Prevention Resource Coordinator Name_______________________ 
 
VA Suicide Prevention Resource Coordinator Phone_______________________ 
5. 
VA Suicide Prevention Hotline Phone: 1-800-273-TALK (8255), push 1 to reach a 
 
VA mental health clinician 
Step 6: Making the environment safe: 
1.  
_______________________________________________________________ 
2. 
_______________________________________________________________ 
Safety Plan Treatment Manual to Reduce Suicide Risk: Veteran Version (Stanley & Brown, 2008). 

CSP #556 - PATIENT STUDY ID CARD  
(Printing on Both sides of card) 
 
 
FRONT SIDE OF CARD 
 
CSP #556 PATIENT IDENTIFICATION CARD  
 Patient’s Name_________________________________________________ 
Address______________________________Phone #________________  
 Subject ID #:___  ___ ___               Subject Treatment #: ___  ___  ___  ___ 
 
 
 
  
    I am participating in a clinical trial being conducted at the 
__________________________________________. During this trial I will 
have repetitive transcranial magnetic stimulation (rTMS) or sham 
treatment that may decrease my depression symptoms.  Please contact 
the physician or nurse listed on the backside of this card if I require 
medical attention that might be affected by my participation in this trial 
or if you have questions regarding the trial.  
 
 
BACK SIDE OF CARD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Card Size – 2 inches high x 3 ½  
 
Dark Salmon 
  
 
 
 
 
 
IN CASE OF EMERGENCY, Please Notify:  
 
Site Investigator:_______________________________________  
 
                   Name                                          Work number  
Nurse: _______________________________________________  
 
                   Name                                           Work number  
 
National Clinical Trial Chairs: Jerome  Yesavage, M.D.  650-852-3287 
                                                   Mark George, M.D.  843-876-5142  
                                                   J. Kaci Fairchild, Ph.D.  650-493-5000 x63432 
Pharmacy Coordinating Center: 505-248-3203  (24 hrs/7days per week)  
Study Biostatistician:  (410) 642-2411 ext 5283                             
This card should be shown to any health care professional  
treating you for any reason.  

Signature                                                                           
Date 
 
Department of Veterans Affairs 
[Insert Site Specific Information Here] 
 
 
 
 
 
 
 
 
 
 
 
 
Dear Veteran:  
 
 
 
 
 
 
 
 
Version April 2014 
 
 
You recently signed an Informed Consent Form indicating: 
 
You will be paid for your time and inconvenience in each of the three study phases as follows: 
 
Screening Phase:     $18 
 
Intervention Phase:  $30 
 
Follow-up Phase:     $27 
 
Additional reimbursement funds are now available. The new reimbursement structure is as follows: 
 
You will be paid for your time and inconvenience in each of the three study phases as follows: 
 
Screening Phase:     $40 
 
Intervention Phase:  $300 
 
Follow-up Phase:     $60 
 
If you withdraw or stop early in any of the three phases, you will be paid according to what phase you 
are in.  For example, if you withdraw at any time during the Intervention Phase you would receive 
payment of $40 for the screening phase and $300 for the Intervention Phase, but not $60 for the follow-
up phase.  If you complete all three phases you would receive a total of $400. 
Your signature below confirms that you have read this memo, or it has been read to you.  You will receive a 
copy of this memo after you sign it.  A copy of this signed memo will be included in the research record.  

Signature                                                                                                                              Date 
Page 1 
 
Department of Veterans Affairs 
[Insert Site Specific Information Here] 
 
 
 
 
 
 
 
 
 
 
 
 
Version February 2016 
 
 
Dear Veteran: 
 
 
 
 
 
 
 
 
 
 
You recently signed an Informed Consent Form for the CSP #556 Study indicating: 
 
There is a possible risk of hearing loss due to the sounds made by the device.  You will 
wear earphones during your rTMS sessions.  This should greatly reduce the possibility of 
hearing loss.  Your hearing will be tested at screening, after the intervention phase, and 
after follow-up to see if any hearing loss has occurred. 
 
Due to recent findings, the study protocol has been changed: 
 
 You will wear earplugs and headphones during your rTMS sessions.  
 Your hearing will be not be tested at screening, after the intervention phase, and after 
follow-up to see if any hearing loss has occurred. 
 If you think your hearing is getting worse during the study, tell the study team right 
away. 
 After your last study treatment, you may keep the headphones if you choose. 
Your signature below confirms that you have read this memo, or it has been read to you.  You 
will receive a copy of this memo after you sign it.  A copy of this signed memo will be included 
in the research record.