Automatic Self-transcending Meditation (ASTM) Therapy Versus Treatment as Usual (TAU) in Late Life Depression: Implications for Cardiovascular Health and Cross-fertilization Across Different Levels of Care.
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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General Info 
FileNo: 104936  
Title: Automatic Self-transcending Meditation (ASTM) therapy versus Treatment As Usual 
(TAU) in late life depression: Implications for cardiovascular health and cross-fertilization 
across different levels of care.  
Start Date: 22/04/2014  
End Date: 31/12/2015  
Keywords: Cardiovascular autonomic testing,Automatic Self transcending meditation,HRV 
biofeedback,Heart Rate Variability  
Project Members 
Principal Investigator 
Prefix: Dr.  
Last Name: Vasudev  
First Name: Akshya  
Affiliation: Schulich School of Medicine and Dentistry\Psychiatry  
Rank: Assistant Professor  
Gender: Male  
Email: akshya.vasudev@uwo.ca  
Phone1: 519-667-6693  
Phone2:  
Fax: 519-667-6707  
Mailing Address: LHSC Zone A, Door 4  
Institution: London Health Sciences Centre  
Country: Canada  
Comments:  
Others 
Rank 
Last 
Name 
First 
Name 
Affiliation 
Role In 
Project 
Assistant 
Professor 
Burhan 
Amer 
Schulich School of Medicine and 
Dentistry\Psychiatry 
Co-
Investigator 
Assistant 
Professor 
Whetmore Stephen 
  
Co-
Investigator 
Resident 
Maldeniya Pramudith Schulich School of Medicine and 
Dentistry\Psychiatry 
Co-
Investigator 
  
Patterson Robert 
  
Co-
Investigator 
Postdoctoral 
Fellow 
Arena 
Amanda 
  
Co-
Investigator 
 Postdoctoral 
Amtul 
Zareen 
 
Co-

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Fellow 
investigator 
 
Shoemaker Kevin 
Health Sciences\Kinesiology 
Other 
Common Questions 
1. 1. Registration Information 
# 
Question 
Answer 
1.1  
Please confirm that you have reviewed the 
eligibility requirements for the Health 
Sciences Full Board application form. 
Yes 
1.2  Indicate the funding source for this study. Granting Agency 
1.3  Please specify the name of the funding 
source selected above. 
AMOSO AHSC AFP INNOVATION FUND 
1.4  Is this a student project? 
No 
1.5  Is this a multi-site study? 
No 
1.6  
If YES has been selected in question 1.5 
above, name the lead site and project 
leader for the study. If the study is 
administered by a Coordinating or Contract 
Research Organization (CRO) provide the 
name and contact information. 
  
1.7  
Are the investigator(s) based at any of the 
sites below or will the study utilize any 
patient data, staff resources or facilities 
within any of these sites? (Please indicate 
all applicable sites and read the associated 
notes found in the blue information icon 
above) 
LHSC - Victoria Hospital|LHSC - University 
Hospital|Regional Mental Health Care - 
London|Byron Family Medical Centre|Victoria 
Family Medical Centre|St. Joseph's Family 
Medical Centre 
1.8  Lay Summary of the study (typically less 
than 5 lines). 
Patients with an episode of late life depression 
will be randomized to Automatic self-
transcending meditation (ASTM)plus Treatment 
as Usual (TAU) or TAU alone to assess changes 
in Heart Rate Variability (HRV, a measure of 
cardiovascular autonomic health, along with 
other secondary measures such as depression, 
anxiety and quality of life. 
2. 2. Background, Methodology and Analysis 
# 
Question 
Answer 
2.1  
Has the study undergone a formal scientific 
or peer review (i.e. CIHR, NSERC, NIH)? 
If yes, please attach the approval letter (or 
No 

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relevant correspondence). 
2.2  
Outline the study rationale including 
relevant background information and 
justification. Cite references where 
appropriate. 
LATE LIFE DEPRESSION AND 
CARDIOVASCULAR AUTONOMIC 
FUNCTION: Major depressive disorder in the 
elderly (in those >60 years of age), also known 
as late life depression (LLD), is common, 
disabling and associated with a high mortality 
rate caused by suicide as well as cardiovascular 
events1 compelling appropriate treatment. 
Research shows that in a naturalistic setting 
response rate to at least one antidepressant trial 
of adequate dose and duration alone is around 
30-40%2 thereby necessitating usage of 
additional interventions3. Such therapies 
include psychological therapies, and, recently, 
various forms of treatments loosely defined as 
mind-body therapies such as biofeedback, 
energy healing, meditation, guided imagery, and 
yoga4. Mind-body therapies are being 
increasingly embraced by patients as they have 
negligible side effects, are easy to administer 
and display beneficial effects on the quality of 
life as well as comorbid anxiety. There is 
increasing research on the mechanisms and 
benefits of such therapies, however, good 
quality trial data is scant. It is well established 
that antidepressants work by mostly modifying 
neurotransmitter levels in the brain5. On the 
other hand, some mind-body therapies target 
multiple organ systems and hence could offer 
neurobiological advantages as depression is now 
recognised as a multi-system disorder. This is 
particularly relevant to the LLD population 
where there is increased prevalence of comorbid 
cardiovascular disorders 3. Hence, some mind 
body therapies when offered in combination 
with antidepressants might have a beneficial 
effect on both depression and the cardiovascular 
system. One of the ways of assessing the 
cardiovascular system is through measurement 
of various autonomic parameters i.e. heart rate, 
blood pressure and heart rate variability. The 
most commonly reported is heart rate variability 
(HRV) which is a manifestation of the interplay 
of the central nervous system and the autonomic 
nervous system on a beat-by-beat basis6. One of 

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the ways of its estimation is by calculating the 
elapsed time between two consecutive waves, 
called R waves, on a person’s electrocardiogram 
(ECG). A consistent finding has been that there 
is reduced HRV in people who have suffered a 
myocardial infarction (MI), and this phenomena 
is a predictor of subsequent cardiac arrhythmia 
and even death7. In addition, through previous 
work the PI has found that in LLD there are 
significant cardiovascular autonomic 
disturbances compared to age matched controls 
after controlling for various risk factors8. Other 
studies conducted in depression across the 
human life span have found similar results9,10. 
Hence, if there is a mind-body treatment that 
specifically targets autonomic dysfunction and 
has a positive benefit on depressive symptoms, 
it would be valuable to assess. The investigators 
would like to investigate such a therapy which 
has been selected based on previous reports of 
beneficial effects but has not been evaluated in a 
randomised controlled trial of LLD patients. 
AUTOMATIC SELF TRANSCENDING 
MEDITATION (ASTM): ASTM is a class of 
meditation that helps quiet the mind and induces 
physiological and mental relaxation whilst the 
eyes are shut. It utilizes a specific sound value 
(mantra) to draw attention inward and permit 
the mind to experience a restful but alert state of 
consciousness11-13. Research suggests that 
ASTM is easier to learn and to teach in 
comparison to other meditation techniques 
including mindfulness14. Studies of adult and 
elderly ASTM practitioners have documented 
reductions in depressive symptoms, as well as 
improvements in cardiovascular function among 
elderly with and without cardiovascular disease. 
A study of adults with CVD further 
demonstrated improvements in HRV 15-18. 
Research further suggests ASTM may be 
particularly well suited to elderly populations. 
In a randomized controlled trial of elderly 
retirement home residents which evaluated 
ASTM with two other meditative techniques 
and treatment as usual, ASTM produced 
significantly greater improvements in cognitive 

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function, cardiovascular function and quality of 
life than all other treatment conditions19. A 
subsequent meta-analysis of all-cause mortality 
rates among hypertensive elderly who had 
participated in stress reduction interventions 
found that ASTM practitioners had a 30% lower 
cardiovascular mortality rate than four other 
meditative or relaxation interventions20. The 
investigators are currently conducting a pilot 
study to explore the feasibility of ASTM on 
HRV measurement and depressive symptoms in 
patients with LLD in a secondary care 
background (UWO HSREB #103966). 
Preliminary results suggest that patients can be 
recruited, find improvement in depressive 
symptoms and tolerate the therapy, confirming 
feasibility of a larger study through this grant. 
We predict that ASTM augmentation is an 
effective intervention that ameliorates the 
autonomic disturbance associated with LLD, 
and possibly has beneficial effects on depressive 
symptoms as compared to a control treatment as 
usual (TAU) group. REFERENCES: 1. Steffens 
DC, Skoog I, Norton MC, et al: Prevalence of 
depression and its treatment in an elderly 
population: the Cache County study. Archives 
of general psychiatry 2000; 57:601-607 2. 
Trivedi MH, Rush AJ, Wisniewski SR, 
Nierenberg AA, Warden D, Ritz L, Norquist G, 
Howland RH, Lebowitz B, McGrath PJ, Shores-
Wilson K, Biggs MM, Balasubramani GK, Fava 
M; STAR*D Study Team. Evaluation of 
outcomes with citalopram for depression using 
measurement-based care in STAR*D: 
implications for clinical practice. Am J 
Psychiatry. 2006 Jan;163(1):28-40. 3. 
Alexopoulos GS. Depression in the elderly. 
Lancet. 2005 Jun 4-10;365(9475):1961-70 4. 
Purohit MP, Wells RE, Zafonte R, Davis RB, 
Yeh GY, Phillips RS. Neuropsychiatric 
symptoms and the use of mind-body therapies. J 
Clin Psychiatry. 2013 Jun;74(6):e520-6. 5. Stahl 
SM, Grady MM. Differences in mechanism of 
action between current and future 
antidepressants. J Clin Psychiatry. 2003;64 
Suppl 13:13-7 6. Heart rate variability for risk 

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stratification of life-threatening arrhythmias. 
American College of Cardiology Cardiovascular 
Technology Assessment Committee. Journal of 
the American College of Cardiology 1993; 
22:948-950 7. Barron HV,Viskin S: Autonomic 
markers and prediction of cardiac death after 
myocardial infarction. Lancet 1998; 351:461-
462 8. Vasudev A, O'Brien JT, Tan MP, et al: A 
study of orthostatic hypotension, heart rate 
variability and baroreflex sensitivity in late-life 
depression. Journal of affective disorders 2011; 
131:374-378 9. Gorman JM,Sloan RP: Heart 
rate variability in depressive and anxiety 
disorders. American heart journal 2000; 140:77-
83 10. R R: Maharishi Mahesh Yogi’s 
Transcendental Meditation. Primus 1994; 
Washington DC: 12. Toane EB: The 
Transcendental Meditation program. Canadian 
Medical Association journal 1976; 114:1095-
1096 13. Travis F, Pearson C. Pure 
consciousness: distinct phenomenological and 
physiological correlates of “consciousness 
itself.” Int J Neurosci. 2000;100(1– 4):77– 89 
14. Lutz A, Slagter HA, Dunne JD, Davidson 
RJ. Attention regulation and monitoringin 
meditation. Trends Cogn Sci. 2008 
Apr;12(4):163-9. 15. Eppley KR, Abrams AI, 
Shear J. Differential effects of relaxation 
techniques on trait anxiety: A meta-analysis. 
Journal of Clinical Psychology Volume 45, 
Issue 6, November 1989. 16. Paul-Labrador M, 
Polk M., Dwyer J, Ivan Velasquez I, Nidich, S, 
Rainforth M, Schneider R, et. al. Effects of a 
Randomized Controlled Trial of Transcendental 
Meditation on Components of the Metabolic 
Syndrome in Subjects With Coronary Heart 
Disease. Arch Intern Med/Vol 166, June 12, 
2006. 17. Nidich, S, Mark T; Myers H; 
Rainforth M; Grandinetti, A, Salerno J, 
Gaylord-King C, Schneider, R. (2010) Change 
in Symptoms of Depression in Minority 
Subjects at Risk for CVD : Randomized 
Controlled Mind-Body Intervention Trials, In 
31st Annual Meeting and Scientific Sessions of 
the Society of Behavioral Medicine, Seattle, 
WA. 18. Barnes VA,Orme-Johnson DW: 

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Prevention and Treatment of Cardiovascular 
Disease in Adolescents and Adults through the 
Transcendental Meditation((R)) Program: A 
Research Review Update. Current hypertension 
reviews 2012; 8:227-242 19. Alexander, C. N., 
Langer, E. J., Newman, R. I., Chandler, H. M., 
and Davies, J. L. (1989). Transcendental 
Meditation, mindfulness, and longevity: an 
experimental study with the elderly. Journal of 
Personality and Social Psychology, 57 (6): 950–
964 20. Schneider, R. H., Alexander, C. N., 
Staggers, F., Rainforth, M., Salerno, J. W., 
Hartz, A., et al. (2005). Long-term effects of 
stress reduction on mortality in persons =55 
years of age with systemic hypertension. 
American Journal of Cardiology, 95 (9): 1060–
1064 is a class of meditation that quiets the 
mind and induces physiological and mental 
relaxation whilst the eyes are shut. It utilizes a 
specific sound value (mantra) to draw attention 
inward and permit the mind to experience a 
restful but alert state of consciousness (9-11). 
There are many systems of meditative practices 
which vary widely in their cognitive procedures, 
goals and subsequently on their specific psycho-
physiological outcomes. Based upon these 
differences, distinct classes of meditation have 
recently been identified (12, 13) MBCT belongs 
to the class of ‘open monitoring’ practices 
which are characterized by dispassionate, non-
evaluative monitoring of ongoing thoughts, 
feelings, sensations and experiences. In contrast, 
the category of ASTM involves taking the 
attention to successively finer states of a thought 
until thought is transcended and the mind 
experiences ‘pure awareness’ itself’, the screen 
of awareness without any object of awareness. 
[14].Open monitoring involves voluntary 
sustained attention, while ASTM involves 
automatic moving from attention to mental 
silence. According to several is recognized as 
ASTM easier to learn and instruct than Open 
Monitoring techniques (12). It also requires 
shorter daily practice. These factors may make 
ASTM particularly useful in clinically 
depressed populations where motivation and 

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compliance with treatment are of concern. 
ASTM has been found to reduce stress and 
improve cardiovascular function in healthy 
adults (12), and to improve cardiovascular 
function, cognitive function and quality of life 
in elderly retirement home residents (13). 
However, its feasibility and effects on HRV in 
people with LLD has not been investigated in a 
randomised trial. Personal experiences of two 
self-paying LLD patients from the PI’s clinical 
case load who recently completed ASTM 
training, as well as a study of retirement home 
residents (13) suggest that ASTM could be 
feasible, appropriately suited to their age, as 
well as effective in reducing their depression 
symptoms. STUDY JUSTIFICATION: We 
suspect that both ASTM would be a feasible 
intervention that can later be tested for its 
potential to ameliorate the autonomic 
disturbance, and possibly have beneficial effects 
on depressive symptoms, in LLD. If so, this 
technique could be offered as treatment choices 
in the future for patients with LLD. 
REFERENCES 1. Steffens DC, Skoog I, Norton 
MC, et al: Prevalence of depression and its 
treatment in an elderly population: the Cache 
County study. Archives of general psychiatry 
2000; 57:601-607 2. Vasudev A, O'Brien JT, 
Tan MP, et al: A study of orthostatic 
hypotension, heart rate variability and 
baroreflex sensitivity in late-life depression. 
Journal of affective disorders 2011; 131:374-
378 3. Gorman JM,Sloan RP: Heart rate 
variability in depressive and anxiety disorders. 
American heart journal 2000; 140:77-83 4. 
Kemp AH, Quintana DS, Felmingham KL, et al: 
Depression, comorbid anxiety disorders, and 
heart rate variability in physically healthy, 
unmedicated patients: implications for 
cardiovascular risk. PloS one 2012; 7:e30777 5. 
Kemp AH, Quintana DS, Gray MA, et al: 
Impact of depression and antidepressant 
treatment on heart rate variability: a review and 
meta-analysis. Biological psychiatry 2010; 
67:1067-1074 6. Servant D, Logier R, Mouster 
Y, et al: [Heart rate variability. Applications in 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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psychiatry]. L'Encephale 2009; 35:423-428 7. 
Heart rate variability for risk stratification of 
life-threatening arrhythmias. American College 
of Cardiology Cardiovascular Technology 
Assessment Committee. Journal of the 
American College of Cardiology 1993; 22:948-
950 8. Barron HV,Viskin S: Autonomic markers 
and prediction of cardiac death after myocardial 
infarction. Lancet 1998; 351:461-462 9. 
http://www.artofliving.org/ca-en/meditation: 10. 
R R: Maharishi Mahesh Yogi’s Transcendental 
Meditation. Primus 1994; Washington DC: 11. 
Toane EB: The Transcendental Meditation 
program. Canadian Medical Association journal 
1976; 114:1095-1096 12. Lutz, A., Slagter, H. 
A., Dunne, J. D., & Davidson, R. J. (2008). 
Attention regulation and monitoring in 
meditation. Trends in cognitive sciences, 12(4), 
163-169. 13. Luders, E., Toga, A. W., Lepore, 
N., & Gaser, C. (2009). The underlying 
anatomical correlates of long-term meditation: 
larger hippocampal and frontal volumes of gray 
matter. Neuroimage, 45(3), 672-678. Travis, F., 
& Pearson, C. (2000). Pure consciousness: 
distinct phenomenological and physiological 
correlates of “consciousness itself”. 
International Journal of Neuroscience, 100(1-4), 
77-89. 
2.3  Study Objectives. 
PRIMARY HYPOTHESIS: We hypothesise 
that in patients with LLD, ASTM+TAU will 
lead to a significant increase in HRV from 
baseline to end of study period as compared to 
TAU alone. SECONDARY HYPOTHESES: 
We hypothesise that ASTM+TAU will cause a) 
significant fall in depression scores b) 
significant improvement in other autonomic 
parameters including resting heart rate and 
blood pressure c) significant improvement in 
depression related symptom pathologies 
including impaired quality of life and anxiety; 
compared to TAU alone. 
2.4  
Describe the study design and 
methodology. Please be specific (e.g. 
Randomized, cohort, double blind). 
STUDY DESIGN: We plan to conduct a single-
centre, single blind longitudinal randomized 
controlled naturalistic trial. Research 
participants will be 96 men and women (48 in 
each group), 60-85 years of age, who have 

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treatment resistant mild to moderate major 
depressive disorder (MDD). Diagnosis of MDD 
will be confirmed through a structured clinical 
interview (Structured Clinical Interview for 
DSM Disorder (SCID)). Participants will be 
recruited from primary, secondary and tertiary 
care centres in London, Ontario. SCREENING 
AND INITIAL ASSESSMENTS: Potential 
participants will be screened as per inclusion 
and exclusion criteria by the PI at the Geriatric 
Mental Health Program (as written in another 
part of the protocol). Upon selection, the 
following scales will be administered: interview 
for comorbid medical conditions (Cumulative 
illness rating scale- Geriatrics, CIRS-G), a 
screening cognitive examination (Mini Mental 
State Examination (MMSE)), depression 
severity assessment (Hamilton Depression score 
(HAM-D 21 items), Clinical Global Impression 
(CGI), self rated Geriatric Depression Scale 
(GDS)), anxiety (Geriatric Anxiety Inventory 
(GAI)), side effects (Toronto Side Effects Scale, 
(TSES)), Quality of Life (QOL profile seniors 
version (QOLPS), physical activity assessment 
(Physical activity scale of the elderly, PASE 
questionnaire) RANDOMIZATION: 
Participants will be randomized to either 
ASTM+TAU or TAU equally (1:1) using 
computer generated randomisation numbers 
available at random.org. Concealment of 
randomisation will be ensured by independent 
staff performing randomisation using a third 
party web based provider 
(http://www.sealedenvelope.com/). 
Computerised randomization will occur from 
the Geriatric Mental Health Program outpatient 
unit in London Health Sciences, London, 
Ontario. A telephone number will be available 
for study concerns/queries. Pre-randomized 
information will be stored using unique de-
identifiers and downloaded on a secure 
database. It will not be possible to blind 
participants to intervention status. Outcome 
assessors and investigators will be blinded to 
treatment. It will not be possible to blind 
participants or staff providing treatment to the 

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intervention status. TRIAL 
INTERVENTIONS/TREATMENT ARMS: 1. 
Automatic Self-Transcending meditation 
(ASTM): Following the initial clinical and lab 
measurements (common to both ASTM and 
control group), participants in the ASTM group 
will undergo ASTM training in groups of four 
by certified teachers under the supervision of 
one of the study co-investigators (RN) at a room 
in Victoria Hospital, LHSC or at the Lawson 
Building on 750 Baseline Road East. This 
involves participating in four, 90-120 minutes 
sessions each of four consecutive days. This will 
be followed by once weekly 45-60 minute 
follow up sessions for 12 weeks. In addition 
participants will be asked to practice ASTM at 
home for 20 minutes twice daily over the study 
period (12 weeks). Participants will be asked to 
log practice frequency and any other noteworthy 
observations in the log sheet provided to them. 
2. Control Intervention: Participants randomized 
to control arm (Treatment as Usual, TAU) will 
continue to receive their treatment as usual 
including antidepressant medications and/or 
non-structured supportive psychotherapy. They 
will follow assessment and study procedures as 
listed below. Following a duration of week 12 
into the study participants in TAU arm will also 
be offered the opportunity to learn ASTM and 
attend follow up meditation sessions. No study 
procedures will be applied or any other 
information collected during this period. 
MEDICATION ADHERENCE FOLLOW UP 
THROUGH 24 WEEK STUDY PERIOD: All 
medication types will be permitted in this study. 
Any dosage modifications will be recorded. 
Medication adherence will be monitored by pill 
count and history at follow up appointments. 
STUDY RECRUITMENT: It is expected that 
the study will recruit from primary secondary 
and tertiary care practices in London identified 
by the investigators at a rate of at least 2 patients 
per week over a period of 76 weeks allowing 
attainment of sample size of n=96. 
Advertisements about the study will be placed at 
key areas around the city including various 

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community centres and libraries. 
2.5  Indicate the inclusion criteria. 
Participants will be considered eligible for 
inclusion in the study if they are: 1. Of either 
gender, between the age range of 60-85 years. 2. 
Have an Axis 1 diagnosis of mild to moderate 
major depressive disorder or bipolar disorder 
with HAMD-21 score of 8 to 22. 3. Consuming 
single agent or combination antidepressant 
therapy at therapeutic doses for a minimum of 
four weeks. 4. Of good general physical health 
with no severe cardiovascular disease in the past 
12 months, no past history of neurological 
disease or seizures or history of diabetic 
neuropathy. 5. Sufficient hearing to be able to 
follow verbal instructions and able to sit without 
physical discomfort for 45 minutes. 6. Willing 
and able to attend 4 initial ASTM training 
sessions and 75% of weekly follow up sessions. 
2.6  Indicate the exclusion criteria. 
Participants will be considered ineligible for 
participating in the study if they are: 1. 
Participating in other similar studies. 2. Other 
significant mental health diagnosis (including 
Dementia, Substance dependence, Post 
traumatic stress disorder, panic disorder, 
Obsessive compulsive disorder, dissociative 
disorder, neurocognitive disorder and 
Personality disorder) 3. High risk of suicide as 
elicited by clinical interview. 4. Psychotic 
episodes within the past 12 months. 5. Recent 
(within the past 6 months) head trauma that 
required emergency care 6. Currently practicing 
any type of formal meditation, mindfulness or 
breathing techniques. 7. patients with severe 
cardiovascular disease in the past 12 months 
(myocardial infarction, stroke or TIA) as well as 
history of neurological disease (including 
Parkinson’s Disease) or seizures NOTE: We are 
aware that patients with depression in this age 
group (60-85 yrs of age) have usually a number 
of comorbidities including hypertension, 
diabetes mellitus and a history of cardiovascular 
as well as cerebrovascular events for which they 
receive appropriate medications including, but 
not limited to, beta blockers, calcium channel 
blockers and antiarrhythmics. Hence, 
realistically speaking it would be impossible to 

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exclude patients who have a history of a 
cardiovascular disease and are on treatment with 
various cardiovascular drugs that could 
influence the autonomic variables that we are 
interested in. However, the investigators are 
confident that by the process of randomization 
to the two treatment arms (ASTM+TAU and 
TAU alone) we shall be able to control for these 
variables equally to both the study arms.  
2.7  
Document the usual standard of care at the 
trial site(s) for this population (including 
diagnostic testing, frequency of follow up 
visits). 
The standard of care for patients with late life 
depression involves starting them on an 
appropriate antidepressant from various classes 
such as SSRIs, (fluoxetine, fluoxamine, 
paroxetine, citalopram, escitalopram, sertraline, 
paroxetine), or NaSSA (mirtazapine) or 
Bupropion. Patients are also prescribed 
additional anxiolytic medications like 
benzodiazepines and trazodone if deemed 
necessary. Participants will be initiated and 
maintained on appropriate dosages of such 
medications as part of standard of care. The 
psychiatrist and/or his multidisciplinary team 
members might offer supportive therapy as part 
of standard of care. 
2.8  Document the study procedures and any 
study specific testing that will be done. 
Automatic self-transcending meditation 
treatment sessions will be conducted, details 
have been provided above. This is a minimally 
invasive treatments not routinely performed as 
part of standard and is done for research 
purposes only. Furthermore, three extra visits to 
the neurovascular research lab will be required 
as a part of this study. These involve HRV 
testing through ECG measurements, along with 
BP measurements. 
2.9  
Will any participant(s) be withdrawn from 
or denied usual therapy, or be subjected to 
other restrictions for any condition in order 
to participate in the study? 
No 
2.10 If YES has been selected in question 2.9 
above, please explain. 
  
2.11 
Describe the primary and secondary 
outcomes of this study and how they will 
be measured. 
PRIMARY (HEART RATE VARIABILITY) 
OUTCOME MEASURES AT WEEK 0, 12 
AND 24: Participants from both arms will be 
asked to report to room 402, Neurovascular 
Research Laboratory or the Laboratory for Brain 

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and Heart Health, Labatt Health Sciences 
Building, Western University Campus (Only 
participants in the ASTM arm will be asked to 
attend follow up assessments at 24 weeks). 1. 
Heart rate will be monitored using an 
electrocardiogram (ECG) with three adhesive 
leads situated on the chest. 2. Blood pressure 
will be measured using a small cuff placed on a 
finger (Finometer) or using a wrist cuff device 
(Colin Pilot). These continuous measures of 
blood pressure will be confirmed against values 
obtained periodically by an automated 
sphygmomanometer (Dinamap). 3. 
Electrocardiogram: A standard 
electrocardiogram will be collected via small 
surface electrodes on the chest to determine 
heart rate. 4. A bellows placed around the chest 
will provide information on respiratory 
excursions. The main outcome of interest, HRV, 
will be calculated by standard deviation of all R-
R intervals (SDNN) on ECG, root-mean square 
of successive differences (RMSSD), and 
number of R-R intervals differing by >50 m sec 
from adjacent intervals (NN50) in time domain 
analysis. All of these tasks are validated and 
performed in this laboratory. A number of 
approved HSREB protocols are in place for the 
same. SECONDARY OUTCOME MEASURES 
(WEEKS 0, 4, 8, 12, and 24): Depression and 
comorbid anxiety symptoms will be assessed by 
a blinded rater on various scales at study visit 
days (week 0, 4, 8, 12 and 24 weeks) (Again, 
only participants in the ASTM arm will be 
asked to attend follow up assessments at 24 
weeks). These scales are (Hamilton Depression 
score (HAM-D 21 items), Clinical Global 
Impression (CGI), self rated Geriatric 
Depression Scale (GDS)), anxiety (Geriatric 
Anxiety Inventory (GAI)), Antidepressant 
medication adherence threshold will be set at 
80% of pills consumed; other consumed 
medications will also be recorded. In addition 
other outcome measures including scales 
Physical activity (PASE), adverse events 
(TSES) and quality of life (QOLPS) will be 
assessed at all study visits (week 0, 4, 8, 12 and 

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24 weeks). ADDITIONAL PROTOCOL 
CONDITIONS: Individual patients will be 
withdrawn from the study interventions if it 
appears that to continue would be deleterious 
for their mental health or safety. This can be 
determined by the patient, the treating clinician 
and/or the research team and will be supported 
by the use of the HAM-D 21 particularly if there 
is an increase in the score for question 18 
“suicide”, or an increase in total HAM-D score. 
2.12 What is the local sample size? 
96 
2.13 What is the total sample size? 
96 
2.14 Is the sample size justified in the sponsor 
or other study protocol? 
No 
2.15 
If YES in question 2.14 above, indicate the 
protocol page number. If NO, provide 
sample size justification. 
The design for this investigation is a split-plot 
partial hierarchical factorial design analysis of 
variance with 2 primary treatment conditions 
(ASTM+TAU vs TAU) tested at fixed time 
intervals. Because the ASTM treatment is to be 
conducted with groups of 4 participants, 
sampling will be done to form random groups of 
four participants each which will be randomly 
assigned to the ASTM or Control condition. 
That is, participants are nested in groups that are 
nested in Treatment condition. The primary 
focus is the interaction effect of treatment on 
heart rate variability at Weeks 0 and 12, with the 
long term benefits assessed at 24 weeks. On the 
assumption that this effect size is medium 
(Cohen’s f = .25), calculations (using 
G*Power)23 indicate that a sample size of 80 (4 
in each of 20 groups) yield power estimates of 
.99 for both the interaction and the main effect 
of time. The power estimate for relevant simple 
main effects of time for the ASTM treatment 
condition is .93 (.83 Bonferroni adjusted). 
Simple main effects of treatment at each level of 
time are not expected for early time periods, but 
could be at 24 weeks with a significant linear by 
linear interaction of time and treatment. This 
contrast is estimated to have a power of .72 
assuming a medium effect, but the effect might 
well be stronger with the cumulative effects of 
time. All secondary variables measured at the 
five time points will be analyzed with a similar 
design (i.e., a 2x5 split plot factorial design 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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analysis of variance with groups crossed with 
time but nested in Treatment condition). With 
the total sample size of 80 this yields power 
estimates of .999 for both Time, and the 
Treatment x Time interaction. It is intended to 
test a total of 96 participants to cover a 
conservative estimate of 20% loss to follow up. 
2.16 Describe the method(s) for data analysis. 
Please see section 2.15 
2.17 Is an interim analysis planned? 
No 
2.18 If YES to question 2.17 above, please 
describe. 
  
2.19 How will the results of this study be made 
public? 
Peer reviewed publication|Presentation 
2.20 If report to participants or other is selected 
above, please explain. 
  
2.21 
Does this study include any use of 
deliberate deception or withholding of key 
information that may influence a 
participant's performance or response? 
No 
2.22 
If YES in question 2.21 above, describe 
this process and provide justification for 
the planned deception or partial disclosure. 
Also describe how and when the 
participants will be debriefed. Please 
include the debriefing letter of information 
and consent. 
  
2.23 
Are biological specimens to be taken or 
analyzed for the purposes of this research 
protocol? 
No 
2.24 
Are any biological specimens being taken 
for future genetic testing or other 
unspecified testing or studies? 
No 
2.25 
The subsequent use of tissue or 
biomaterials (except blood) originally 
collected for diagnostic purposes must be 
approved by the Department of Pathology 
Tissue Use Committee prior to submission 
to the HSREB and a copy of their approval 
appended to this form. If the Tissue 
Committee approval is not available at the 
time of submission to the HSREB, ethics 
approval will be withheld until a copy of 
Tissue Committee approval is received. 
Not applicable 
3. 3. Drugs and Natural Products 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
# 
Question 
Answer 
3.1  
Does the study involve drugs or natural 
products? If NO, please proceed to the 
Clinic Trials tab. 
No 
3.2  Is Drug 1 an investigational drug? 
  
3.3  Drug 1 - Generic Name 
  
3.4  Drug 1 - Brand Name 
  
3.5  Drug 1 - Dose 
  
3.6  Drug 1 - Frequency 
  
3.7  Drug 1 - Route 
  
3.8  Drug 1 - Duration 
  
3.9  Is Drug 2 an investigational drug? 
  
3.10 Drug 2 - Generic Name 
  
3.11 Drug 2 - Brand Name 
  
3.12 Drug 2 - Dose 
  
3.13 Drug 2 - Frequency 
  
3.14 Dose 2 - Route 
  
3.15 Drug 2 - Duration 
  
3.16 Is Drug 3 an investigational drug? 
  
3.17 Drug 3 - Generic Name 
  
3.18 Drug 3 - Brand Name 
  
3.19 Drug 3 - Dose 
  
3.20 Drug 3 - Frequency 
  
3.21 Drug 3 - Route 
  
3.22 Drug 3 - Duration 
  
3.23 Is Drug 4 an investigational drug? 
  
3.24 Drug 4 - Generic Name 
  
3.25 Drug 4 - Brand Name 
  
3.26 Drug 4 - Dose 
  
3.27 Drug 4 - Frequency 
  
3.28 Drug 4 - Route 
  
3.29 Drug 4 - Duration 
  
3.30 Is Drug 5 an investigational drug? 
  
3.31 Drug 5 - Generic Name 
  
3.32 Drug 5 - Brand Name 
  
3.33 Drug 5 - Dose 
  
3.34 Drug 5 - Frequency 
  
3.35 Drug 5 - Route 
  
3.36 Drug 5 - Duration 
  
3.37 Is Drug 6 an investigational drug? 
  

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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3.38 Drug 6 - Generic Name 
  
3.39 Drug 6 - Brand Name 
  
3.40 Drug 6 - Dose 
  
3.41 Drug 6 - Frequency 
  
3.42 Drug 6 - Route 
  
3.43 Drug 6 - Duration 
  
3.44 Is Drug 7 an investigational drug? 
  
3.45 Drug 7 - Generic Name 
  
3.46 Drug 7 - Brand Name 
  
3.47 Drug 7 - Dose 
  
3.48 Drug 7 - Frequency 
  
3.49 Drug 7 - Route 
  
3.50 Drug 7 - Duration 
  
3.51 Is Drug 8 an investigational drug? 
  
3.52 Drug 8 - Generic Name 
  
3.53 Drug 8 - Brand Name 
  
3.54 Drug 8 - Dose 
  
3.55 Drug 8 - Frequency 
  
3.56 Drug 8 - Route 
  
3.57 Drug 8 - Duration 
  
3.58 Is Drug 9 an investigational drug? 
  
3.59 Drug 9 - Generic Name 
  
3.60 Drug 9 - Brand Name 
  
3.61 Drug 9 - Dose 
  
3.62 Drug 9 - Frequency 
  
3.63 Drug 9 - Frequency 
  
3.64 Drug 9 - Route 
  
3.65 Drug 9 - Duration 
  
3.66 Is Drug 10 an investigational drug? 
  
3.67 Drug 10 - Generic Name 
  
3.68 Drug 10 - Brand Name 
  
3.69 Drug 10 - Dose 
  
3.70 Drug 10 - Frequency 
  
3.71 Drug 10 - Route 
  
3.72 Drug 10 - Duration 
  
4. 4. Clinical Trials 
# 
Question 
Answer 
4.1  Is this a clinical trial? If this is NOT a 
Yes 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
clinical trial, please select NO and proceed 
to the Risks and Benefits section. 
4.2  Proposed type of clinical trial: 
Phase 3 
4.3  
Does this trial involve a drug, device or 
natural health product used for an 
indication outside the Health Canada 
Notice of Compliance (NOC) or Drug 
Identification Number (DIN) application or 
Medical Device License? 
No 
4.4  
If YES to question 4.3 above, have you 
received a No Objection Letter (NOL) or 
comparable document from Health 
Canada? 
  
4.5  Is this a US Food and Drug Administration 
monitored study? 
No 
4.6  
Has this study been or will this study be 
registered on a publicly accessible clinical 
trial registry? 
Yes 
4.7  
If YES is specified in question 4.6 above, 
please indicate the registry name and 
registration number. 
Will be registered on clinicaltrials.gov 
4.8  
Is there a data safety monitoring board 
(DSMB)? If YES, please note that you 
must submit the Data Safety Monitoring 
Committee report(s) to the Office of 
Research Ethics using Form 2-F-014. 
No 
4.9  If there is a DSMB, is it independent of the 
sponsor? 
No 
4.10 If NO in question 4.9 above, please provide 
justification. 
  
4.11 Has the drug or other therapy been 
evaluated in previous human trials? 
Not applicable 
4.12 
If NO in question 4.11 above, please 
describe any animal studies that have led to 
this study. (Cite references where 
applicable) 
  
4.13 Will this trial use a placebo or active 
comparator? 
No 
4.14 
If YES in question 4.13 above, please 
describe the placebo or active comparator 
and justify its inclusion. Also, please 
describe how the risks to participants will 
be minimized. 
  

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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5. 5. Risks and Benefits 
# 
Question 
Answer 
5.1  Describe any direct benefits to the study 
participants.  
Automatic self transcending meditation 
participants may benefit from participating in 
this treatment. The technique is known to draw 
attention inward and permit the mind to 
experience a restful but alert state of 
consciousness. (1, 2, 3) There has been some 
evidence for ASTM to reduce stress and 
improve cardiovascular function in healthy 
adults(5). Also, there is documented 
improvement in cardiovascular function, 
cognitive function and quality of life in elderly 
retirement home residents (4). We are uncertain 
whether these benefits would translate to elderly 
depressed subjects and this is one of the purpose 
of our study. 1) R R: Maharishi Mahesh Yogi’s 
Transcendental Meditation. Primus 1994; 
Washington DC: 2) Toane EB: The 
Transcendental Meditation program. Canadian 
Medical Association journal 1976; 114:1095-
1096 3) Travis F, Pearson C. Pure 
consciousness: distinct phenomenological and 
physiological correlates of “consciousness 
itself.” Int J Neurosci. 2000;100(1– 4):77– 89 4) 
Barnes VA,Orme-Johnson DW: Prevention and 
Treatment of Cardiovascular Disease in 
Adolescents and Adults through the 
Transcendental Meditation((R)) Program: A 
Research Review Update. Current hypertension 
reviews 2012; 8:227-242 5) Alexander, C. N., 
Langer, E. J., Newman, R. I., Chandler, H. M., 
and Davies, J. L. (1989). Transcendental 
Meditation, mindfulness, and longevity: an 
experimental study with the elderly. Journal of 
Personality and Social Psychology, 57 (6): 950–
964 6) Karavidas MK, Lehrer PM, Vaschillo E, 
et al: Preliminary results of an open label study 
of heart rate variability biofeedback for the 
treatment of major depression. Applied 
psychophysiology and biofeedback 2007; 32:19-
30 7) Siepmann M, Aykac V, Unterdorfer J, et 
al: A pilot study on the effects of heart rate 
variability biofeedback in patients with 
depression and in healthy subjects. Applied 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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psychophysiology and biofeedback 2008; 
33:195-201 
5.2  Describe the potential benefits to society. 
At present it is difficult to determine direct 
potential benefits to society. 
5.3  
List and describe the potential 
risks/harms/inconveniences of the study, 
including risks from radiation exposure. 
This information must be included in the 
informed consent documentation. 
During study period: Automatic Self-
transcending meditation, will be applied to 
subjects over a 12-week period. Even though 
there are no known direct risks of ASTM, some 
reported adverse effects include relaxation-
induced anxiety; boredom; feeling addicted to 
the technique; and mild dissociation with all 
meditative techniques. However, such effects 
have been found mostly in individuals who 
practice meditative techniques for several years; 
no other short-term adverse events have been 
reported. At week 0 and week 12: we shall 
measure height, weight, ECG, pulse monitor, 
blood pressure measurement (with finger cuff 
and arm cuff), respiratory belt around ribcage 
(to assess breathing rate and depth) These are 
minimally invasive tests with no known direct 
risks. With the use of finger and arm cuffs 
possibly, with prolonged use there may be 
numbness and discolouration but this resolves 
upon removal of the cuff. ECG testing may 
cause some discomfort when electrodes are 
removed and the adhesive may cause some 
redness to the skin.  
5.4  
For the study risks listed above, describe 
the monitoring to be undertaken during and 
following the study conclusion. 
All scientific instruments and the therapy 
modality has been previously seen to have 
minimal to no discomfort. All sites have access 
to first aid and CPR in the event of an 
emergency. Participants will also be asked to 
indicate any discomfort, at which time the 
appropriate adjustments will be made, including 
discontinuation of the experiment for that 
participant if necessary. Whilst participants are 
practicing ASTM techniques at their own 
homes, there is no additional perceived risks to 
their physical or mental health. To minimize 
risk of acute suicidality and acute distress, based 
on inclusion criteria we shall recruit patients 
who are considered at low risk of suicide as 
elicited by clinical interview. At both the initial 
interview and during frequent follow up 
interviews (4 weeks, 8 weeks and 12 weeks into 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
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the study period), any concerns of acute distress 
and active suicidality/self harm will be first of 
all assessed by the PI and/or his clinical team 
and if there is considered an imminent risk such 
patients will be referred to the Psychiatry 
Emergency (CEPS) at Victoria Hospital. 
5.5  
If a research participant is/or becomes 
pregnant, breastfeeds a child or fathers a 
child while in the study, does their 
participation in the study pose a possible 
risk to the fetus or child? 
No 
5.6  
If YES is selected in question 5.5 above, 
please discuss these risks and indicate what 
monitoring will be undertaken during the 
study and following the study conclusion?  
  
5.7  
If a research participant fathers a child 
while in the study, will access to the health 
records of the "pregnant" partner and/or her 
child be required and/or will the woman or 
child be monitored by this study during 
and/or after the pregnancy? 
No 
6. 6. Recruitment and Informed Consent 
# 
Question 
Answer 
6.1  Describe the method(s) for recruiting 
participants. 
Investigators will approach their own 
patients/students|Investigators will receive 
referrals from other Healthcare 
providers|Advertising (i.e. poster or email or 
web-based). Please submit a copy of all 
advertisements.|Database of people who 
consented to future contact (please provide REB 
number or database name below) 
6.2  
If OTHER or DATABASE OF PEOPLE is 
selected in question 6.1 above, please 
specify here. 
REB protocols #102574, #100749, 
6.3  Will personal health information (PHI) be 
used to identify potential participants? 
No 
6.4  
If PHI will be used, please describe the 
screening and consent process regarding 
PHI. 
  
6.5  
How will potential participants be 
contacted? Please provide a copy of all 
telephone scripts and correspondence 
documents in the attachments tab. 
In Person|Other 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
6.6  If OTHER is selected in question 6.5 
above, please specify in this box. 
A poster in various primary care offices will be 
used to recruit participants to our study. Posters 
shall be placed in various community centres 
and libraries as well. Please see attached poster. 
6.7  
Describe the process for obtaining 
informed consent. Please attach a copy of 
the Information Letter/Consent Form, 
Audio/Video Recording Consent Form, 
and the content of any telephone script 
and/or any other material that will be used 
in the informed consent process.  
Please see attached Letter of information. 
6.8  Indicate if the research will involve any of 
the following: 
Patients 
6.9  Will minors or persons not able to consent 
for themselves be included in the study? 
No 
6.10 
If YES is selected in question 6.9 above, 
describe the consent process and indicate 
who will be asked to consent on their 
behalf and discuss what safeguards will be 
employed to ensure the rights of the 
research participant are protected.  
  
6.11 
When the inability to provide an informed 
consent is expected to be temporary, 
describe what procedures will be used to 
regularly assess capacity and to obtain 
consent if the individual later becomes 
capable of providing consent. 
Alternatively, if diminished capacity is 
anticipated for the study population, 
describe the procedure used to assess 
capacity and obtain ongoing consent. 
  
6.12 List any anticipated communication 
difficulties: 
None 
6.13 Describe the procedures to address any 
communication difficulties (if applicable):   
6.14 
Indicate what compensation, if any, will be 
provided to participants and include a 
justification for compensation. 
Each participant will be reimbursed for travel 
costs by receiving $ 150 in total for the 
assessment visits. 
7. 7. Confidentiality and Data Security 
# 
Question 
Answer 
7.1  Are you collecting personal identifiers for 
this study? 
Yes 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
7.2  Identify any personal identifiers collected 
for this study. Select all that apply. 
Full name|Telephone number|Email|Date of 
birth 
7.3  Explain and justify the use of this identifier 
- Full name: 
The name, phone number and email address of 
the participants will be collected so that we can 
contact them regarding the scheduling of the 
tests. 
7.4  Explain and justify the use of this identifier 
- Initials: 
  
7.5  Explain and justify the use of this identifier 
- Health card number: 
  
7.6  Explain and justify the use of this identifier 
- Address: 
  
7.7  Explain and justify the use of this identifier 
- Full postal code: 
  
7.8  Explain and justify the use of this identifier 
- Partial postal code: 
  
7.9  Explain and justify the use of this identifier 
- Telephone number: 
The name, phone number and email address of 
the participants will be collected so that we can 
contact them regarding the scheduling of the 
tests. 
7.10 Explain and justify the use of this identifier 
- Email: 
The name, phone number and email address of 
the participants will be collected so that we can 
contact them regarding the scheduling of the 
tests. 
7.11 Explain and justify the use of this identifier 
- Family Physician: 
  
7.12 Explain and justify the use of this identifier 
- Date of birth: 
  
7.13 Explain and justify the use of this identifier 
- Partial date of birth: 
For the study purposes year and month only be 
collected. Some participants might have the 
same year of birth hence additional month as an 
identifier will be collected. 
7.14 Explain and justify the use of this identifier 
- Hospital number: 
  
7.15 Explain and justify the use of this identifier 
- Other: 
  
7.16 Where will information collected as part of 
this study be stored? (select all that apply) 
University or Hospital network drive (specify 
below)|Memory stick 
7.17 If required, please specify further 
information below. 
All participant data will be kept on password 
protected and encrypted, secure portable media 
drives or on LHSC secure network servers. 
7.18 
If identifiable participant information is 
stored on a hard drive or portable device, 
the device must be encrypted. Describe the 
Data will be encrypted and password protected 
through freely available software, 7-zip. 
www.7-zip.org/. The data contained on portable 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
encryption being used. 
media would be stripped of all participant 
identifiers. 
7.19 How will you record study data? 
Data will be recorded first using a case report 
form that is attached to this proposal. These will 
be kept in a locked facility in the PI's office in 
London. Patient identifiers will not be included 
in the case report file. Only participant ID 
included and data will remain anonymous when 
statistically analyzed. 
7.20 
Describe the coding system to protect 
identifiable information or explain why the 
data must remain identifiable. 
Datasets will only have information pertaining 
to the participant unique code as the identifier 
e.g. PNS001. 
7.21 
How will you store and protect the master 
list, signed original letters of information 
and consent documents or other data with 
identifiers? 
Paper file (Required Protection: Locked cabinet 
in locked institutional office) 
7.22 If any options are selected above, please 
provide the specific details here. 
The master list, signed letters of information and 
case report forms containing the personal 
identifiers will be kept in a locked facility in the 
PI’s office in London, Ontario. 
7.23 How will you store and protect data 
without identifiers? 
Data will be encrypted and password protected 
through freely available software, 7-zip. 
www.7-zip.org/. The data may also be stored in 
flash drives that would be encrypted and 
password protected as well as secure LHSC 
servers. 
7.24 
If you plan to de-identify the study data, 
please describe the method of de-
identification. 
Datasets will only have information pertaining 
to the participant unique code as the identifier 
e.g. PNS001. 
7.25 How long will you keep the study data? 
Participant data will be kept up to a maximum 
of 10 years. 
7.26 How will you destroy the study data after 
this period? (If applicable) 
Study data on flash drives and other media will 
be wiped and formatted afterwards to ensure 
proper destruction. Similarly, folders on 
network drives will be formatted as well. 
7.27 
Does this study require you to send data 
outside of the institution where it is 
collected? This includes data taken off-site 
for analysis. Please note that 
Western/Robarts are considered off-site 
locations for hospital/Lawson based 
studies, and vice-versa. 
Yes 
7.28 Where will the data be sent? 
Deidentified data will be transferred between 
Dr. Vasudev and his coinvestigators, Mrs. 
Newman, Dr. Shoemaker. Dr. Shoemaker is 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
located at Western University. Mrs. Newman 
belongs to the Art of Living Foundation, 
Canada. 
7.29 
Does the data to be transferred include 
personal identifiers? If yes, a data transfer 
agreement may be necessary. 
No 
7.30 List the personal identifiers that will be 
included with the data sent off-site. 
  
7.31 How will the data be transmitted? 
Secure file transfer 
7.32 Please specify any additional details on 
data transmission below. 
Data may be sent electronically to co 
investigators in a secure and safe format through 
the internet using e-mail systems of Western 
University or LHSC. Prior to transmittal, de-
identified data will be encrypted and password 
protected through freely available software, 7-
zip. www.7-zip.org/. 
7.33 Will you link the locally collected data 
with any other data sets? 
No 
7.34 If YES is selected in question 7.33 above, 
identify the dataset 
  
7.35 If YES is selected in question 7.33 above, 
explain how the linkage will occur. 
  
7.36 
If YES is selected in question 7.33 above, 
provide a list of data items contained in the 
dataset. 
  
7.37 Will the study data be entered into a 
database for future use? 
No 
7.38 
If YES is selected in question 7.37 above, 
please specify where it will be stored, who 
the custodian will be, who will have access 
to the database and what security measures 
will be in place. 
  
7.39 
Please list agencies/groups/persons outside 
of your local research team who will have 
access to the identifiable data and indicate 
why access is required. 
NONE 
8. 8. Conflict of Interest 
# 
Question 
Answer 
8.1  
Will any investigators, members of the 
research teams, and/or their partners or 
immediate family members function as 
advisors, employees, officers, directors or 
No 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
consultants for a study-related sponsor or 
funding source? 
8.2  
Will any investigators, members of the 
research team, and/or their partners or 
immediate family members have a direct or 
indirect financial interest (including patents 
or stocks) in the drug, device or technology 
employed in this research study? 
No 
8.3  
Will any investigators, members of the 
research team, and/or their partners or 
immediate family members receive any 
personal benefit (apart from fees for 
service) as a result of, or connects to this 
study? 
No 
8.4  
If YES is selected in any of the above, 
please describe the nature of the conflict of 
interest and how all conflict(s) of interest 
will be managed. 
  
9. 9. Industry Sponsored Protocols 
# 
Question 
Answer 
9.1  Is this an industry sponsored protocol? 
No 
9.2  Billing Information - Company Institution:   
9.3  Contact Person: 
  
9.4  Email of Contact Person: 
  
9.5  Street Address: 
  
9.6  City: 
  
9.7  Country: 
  
9.8  Province/State: 
  
9.9  Phone Number: 
  
9.10 Fax: 
  
9.11 Contract and/or protocol reference number 
required: 
  
9.12 Additional Sponsor Reference or contact 
information: 
  
9.13 Do you wish to apply for a REB 
Administration Fee Adjustment/Waiver? 
  
9.14 Do you agree to the Conditions for 
Industry Funded Research Investigators? 
  
9.15 
Do you agree to provide supporting 
documents? (These can be added in the 
attachments section) 
  

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
10. 10. Confirmation of Responsibility 
# 
Question 
Answer 
10.1 
I assume full responsibility for the 
scientific and ethical conduct of the study 
as described in this REB application and 
submitted protocol. 
Yes 
10.2 
I agree to conduct this study in compliance 
with the Tri-Council Policy Statement 
(TCPS2), Ethical Conduct in Research 
Involving Humans and any other relevant 
regulations and guidelines. 
Yes 
10.3 
I certify that all researchers and other 
personnel involved in this project at this 
institution are appropriately qualified and 
experienced or will undergo appropriate 
training to fulfill their role in this project. 
Yes 
10.4 I certify that any and all conflicts of 
interest have been declared. 
Yes 
10.5 
I have obtained all necessary resource 
utilization signatures, and all costs 
associated with the use of these resources 
have been declared. 
Yes 
10.6 
On behalf of my research team, I recognize 
the importance of maintaining the 
confidentiality of all personal information, 
including personal health information, and 
the privacy of individuals with respect to 
that information. I will ensure that the 
personal information is used only as 
necessary, to fulfill the specific research 
objectives and related research questions 
described in this application and approved 
by the REB. This includes all conditions 
and restrictions imposed by the REB 
govern 
Yes 
10.7 
I will adhere to the Protocol and Informed 
Consent document as approved by the 
Health Sciences REB.  
Yes 
10.8 
Have you exported a copy of this 
submission to Word using the "Export to 
Word" button? Note that you will be 
unable to submit future revisions if this is 
not done. 
Yes 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
Attachments 
Description 
File Name 
Version 
Date 
CGI - I -Received Jan 29, 2014 
ClinicalGlobalImpressionCGI-I(1).doc 
08/01/2014 
CIRS G-Received Jan 29, 2014 
Appendix_5_CIRS_G[1].pdf 
 
Medication Adherence Form-Received 
Jan 29, 2014 
Medication Adherence Record(1).docx 
 
HAMD21-Received Jan 29, 2014 
HAMD(1).pdf 
 
Physical Assessment Scale for Elderly, 
PASE (Standardized Clinical 
Questionnaire)-Received Jan 29, 2014 
CSM_PASE.pdf 
 
Geriatric Depression Scale 
(standardized questionnaire)-Received 
Jan 29, 2014 
GDS(1).pdf 
 
original 
ASTM versus TAU AMOSO protocol, 
January 12th 2014 final.docx 
18/01/2014 
Quality of Life Profile Seniors Version-
Received Jan 29, 2014 
QOLPS scale.pdf 
 
Letter of information 
2 arm RN comments_ LOI ASTM vs TAU 
January 06 2014 final.docx 
06/01/2014 
Case Report File 
Case Report form- ASTM versus TAU Dec 
13 2013 final.docx 
08/12/2013 
Advertisement 
ASTMvs TAU ad final.docx 
18/01/2014 
Geriatric Anxiety Inventory-Received 
Jan 29, 2014 
GAI new English-USA.pdf 
 
Toronto Side Effects Scale-Received 
Jan 29, 2014 
Toronto Side Effects Scale.docx 
18/01/2014 
original 
104936 Vasudev Protocol.docx 
 
  
104936 Vasudev.docx 
 
  
28th Feb ASTM vs TAU ad final.docx 
28/02/2014 
v2, TRACKED 
28th Feb 2014 REB protocol ASTM versus 
TAU with changes.docx 
28/02/2014 
  
28th feb 2014 LOI ASTM vs TAU .pdf 
28/02/2014 
Tracked 
28th feb 2014 LOI ASTM vs TAU .docx 
28/02/2014 
Recommendation #2 
104936 Vasudev (recomm..pdf 
28/03/2014 
V2 Case Report form- ASTM versus 
TAU -TRACKED 
28th Fec V2 Case Report form- ASTM 
versus TAU .docx 
27/02/2014 
V2 Case Report form- ASTM versus 
TAU 
28th Fec V2 Case Report form- ASTM 
versus TAU .pdf 
27/02/2014 
  
28th Feb Appendix ASTM Vs TAU.pdf 
28/02/2014 
  
28th Feb Appendix ASTM Vs TAU.docx 
28/02/2014 

ASTM versus TAU Protocol Version 5, 11/12 /2014 
11/12/2014 
v2, including Appendix ASTM Vs TAU 28th Feb 2014 REB protocol ASTM versus 
TAU with changes.pdf 
28/02/2014 
v2 
28th Feb ASTM vs TAU ad final.pdf 
28/02/2014 
2nd recommendation letter 
104936 Vasudev (recomm..pdf 
28/02/2014 
  
104936 Vasudev.pdf 
14/02/2014 
Response to board recommendation 
Response to Health Science Research 
Ethics Board recommendations april 3rd 
.pdf 
02/04/2014 
Version 3  
V3 ASTM vs TAU ad final March 31ST 
2014.docx 
31/03/2014 
Version 3  
V3 MARCH 31ST 2014 LOI ASTM vs 
TAU .pdf 
10/03/2014 
Word tracked document of version 3 
advertisement 
V3 ASTM vs TAU ad final March 31ST 
2014.docx 
31/03/2014 
Word tracked document of version 3 of 
letter of information 
V3 MARCH 31ST 2014 LOI ASTM vs 
TAU .docx 
31/03/2014 
V3 Case Report form- ASTM versus 
TAU 
1st April V3 Case Report form- ASTM 
versus TAU .pdf 
01/04/2014 
CGI –I, version 2 
v2 Clinical Global Impression Scale April 
10th 2014.pdf 
10/04/2014 
V3 Case Report form- ASTM versus 
TAU-TRACKED 
1st April V3 Case Report form- ASTM 
versus TAU .docx 
01/04/2014 
initial approval notice 
DOC042414-04242014151641-0004.pdf