Conditions: Suicidal Ideation
Keywords: ketamine suicidal ideation length of stay
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.

Detailed description:
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.

Arms:
arm 1: Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. arm 2: Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.

Interventions: intervention 1: Ketamine intervention 2: Normal Saline
Intervention descriptions: intervention 1: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes. intervention 2: IV infusion of 100 ml of normal saline over 45 minutes.

Protocol document:
Prot_SAP_001.pdf: 
Page 1 of 7 
Ketamine: its effects on suicidal ideations and 
inpatient hospital length of stay. 
 
 
 
NCT02997722 
 
 
 
 
 
11/06/2017 
 
 
 
 


Page 2 of 7 
 
RESEARCH PROTOCOL  
 
 
Title 
 
Ketamine: its effects on suicidal ideations and inpatient hospital length of stay 
Faculty Sponsor 
 
Allen Richert, MD 
Principle 
Investigator/Co-
investigators 
Allen Richert, MD 
Abstract 
Patients admitted to the University of Mississippi Medical Center’s (UMMC) 
inpatient psychiatry unit for suicidal ideations will be given the opportunity to 
participate in the study. Within 24 hours of arriving to the inpatient psychiatric 
floor, patients who choose to participate will be randomized to receive either a 
placebo saline infusion or a ketamine infusion of 0.5 mg/kg over the course of 45 
minutes.  Infusions will take place in the UMMC Post Anesthesia Care Unit and/or 
Short Stay Procedure Area. Patients will be monitored for 30 minutes after the 
completion of their infusion. We will assess all patients' suicidal ideations daily 
while they are inpatient at UMMC and our primary outcome will be their 
inpatient hospital course length.  
 
 
 
 
Background  
 
 
 
Recent studies demonstrate ketamine can positively impact a patient 
experiencing suicidal ideations. Ketamine is a NMDA receptor antagonist and has 
also been shown to have anti-inflammatory effects. There is an association 
between depression and tumor necrosis factor-alpha as well as interleukin-6 and 
ketamine has been demonstrated to inhibit both tumor necrosis factor-alpha and 
interleukin-6. Ketamine works quickly, and the anti-depressant effects have 
repeatedly been shown to be statistically significant in 24 hours or less. Though 
ketamine has repeatedly been proven to decrease depressive symptoms, no 
studies have been conducted evaluating whether or not ketamine shortens the 
hospital course of a patient admitted with suicidal ideations. Decreasing the 
inpatient hospital course of a patient admitted for suicidal ideations by as little as 
one day would save thousands in healthcare dollars. 
 
Purpose 
 
 
The hypothesis is that ketamine infusions administered to patients with suicidal 
ideation will help resolve the suicidal ideation more quickly and result in a shorter 
length of stay than in patients receiving the placebo infusions. The patients will 
also be assessed for improvement of their suicidal ideations by utilizing the Scale 
of Suicidal Ideation. 
Specific Aim(s) 
 
Our aim is to decrease the length of patients’ inpatient hospital course. 
 
Study Period (inclusive 
years) 
Approximately one year to conduct study and an additional six months to follow-
up on subjects and assess readmission rates. 


Page 3 of 7 
Study Design 
Patients with suicidal ideations who agree to participate in this study will be 
enrolled within 24 hours of being admitted to the UMMC inpatient psychiatric 
service. In order to assess the patient’s decisional capacity, a structured protocol 
will be followed.  Only IRB-approved research team members trained in the 
consent process will consent subjects.  During the consent process the 
investigator will perform a structured assessment of the subjects’ capacity to 
make decisions regarding participating in our protocol.  The assessment will occur 
after the investigator has reviewed the protocol with the patient and the patient 
has had an opportunity to read the consent form.  Introducing the study and 
obtaining consent will occur in a private area. The investigator's review of the 
protocol will highlight the following: 
 
 
participation is voluntary 
 
the purpose of the protocol is to determine if the experimental 
medication reduces the length of hospitalization  
 
the name of the experimental medication (in this case ketamine) 
 
the potential side effects of the medication 
 
that participating will require placement of a needle in their vein to 
administer the study medication  
 
the fact that they have a 50% chance of receiving placebo instead of the 
experimental medication and that they will not be told which they are 
getting. 
 
the fact that the patient will not be penalized if they decide to not 
participate in the study 
 
Prior to signing the consent form the potential subject will be asked to answer 
the following list of multiple choice questions designed to test the subject's 
decisional capacity related to consenting for the protocol. 
 
 
Which of the following is true? 
1. I must sign the consent form and I have to participate in this 
study. 
2. I do not have to sign the consent form or participate in this study 
if I do not want to participate. 
3. I do not have to participate in this study but if I choose not to 
participate I must leave the hospital. 
4. I do not have to participate in this study but if I do I will earn 
money. 
 
The purpose of the study is to determine if the experimental medication: 
1. causes hallucinations 
2. improves sleep 
3. reduces the length of hospitalization 
4. reduces anxiety 
 
The name of the medication tested in this study? 
1. Ketamine 
2. Zofran 
3. Ativan 
4. Prozac 
 
Which of the following are potential side effects from the medication 
used in this study? 


Page 4 of 7 
Study Design 
(continued) 
1. insomnia, anxiety, headaches 
2. hair loss, diarrhea, tingling in the feet 
3. ringing or the ears, loss of smell, tooth pain 
4. racing heartbeat, high blood pressure, hallucinations 
 
Is getting stuck with a needle part of the study? 
1. Yes, an IV which is a needle in the vein 
2. No, getting stuck with a needle is not part of the study 
3. Yes, an injection in the shoulder. 
4. Yes, a prick of the finger to get a blood sample 
 
Will you definitely receive the experimental medication? 
1. Yes, I will definitely receive the real medication 
2. No, I might not receive the real medication but I will be told if I 
do not. 
3. No, I will not know if I get the fake or real medicine 
4. No, I will definitely receive the fake medicine 
 
The investigators will consider greater than two incorrect responses 1) evidence 
of a deficiency in decisional capacity related to the consent process and 2) a 
criterion for excluding the potential subject from the study.  If the potential 
subject gives no more than two incorrect responses the investigator will ask the 
subject to explain the incorrect responses.  If in discussion of the incorrect 
responses the investigator feels that the potential subject actually has a correct 
understanding of the issues covered in the incorrectly answered questions, the 
investigator will 1) record on the questionnaire why he believes the potential 
subject understands the incorrectly answered issues and 2) proceed with the 
consent process.  The investigator will consider the potential subject's failure to 
understand even one of the issues 1) evidence of a deficiency in decisional 
capacity and 2) criteria for excluding the potential subject from the 
study.  Correct answers for all the questions will serve as evidence of decisional 
capacity and the potential subject's ability to consent to participate.  If the 
potential subject agrees to participate, he/she will be assured that participation 
in the study is confidential.  After appropriate decisional capacity has been 
assured, the patient will be assigned at random to one of the following groups: 
 
 
Group A: receives ketamine intravenous (IV) infusion over 45 minutes 
 
Group B: receives saline (salt solution) over 45 minutes 
 
The infusion will be administered in either the Post-Anesthesia Care Unit (PACU) 
or Short Stay Procedure Area (SSPA). After receiving the infusion, the patient will 
be monitored for an additional 30 minutes by medical personnel in either the 
PACU or SSPA. This study will be a randomized, double blind cohort study, so 
neither the patient nor the study doctor will know which infusion is being 
administered. While receiving the infusion, the patient’s vital signs (including 
heart rate, heart rhythm, blood pressure, respiratory rate, and temperature) will 
be monitored on an anesthesia paper chart. After the patient is discharged from 
the hospital, the treatment team will analyze the patient’s medical record and 
compare the length of hospital stay between the control and treatment groups. 
The only information about the patient’s hospital stay that will be analyzed will 
be the length of hospital stay. 
 


Page 5 of 7 
 
Study Design 
(continued) 
If a patient is a woman of childbearing age, a urine pregnancy test will be 
performed after you agree to enroll in the study. The cost of this test will be 
covered by the University of Mississippi Departments of Anesthesiology and 
Psychiatry.  If you are found to be pregnant, you will not be able to participate in 
the study. 
 
Patients admitted after suicidal attempt may be enrolled in the study. Those who 
attempted suicide by medication overdose may participate in the study, but must 
be cleared by a medical toxicology specialist prior to enrollment.  Due to 
cardiovascular adverse effects of ketamine, all participants will receive a 12-lead 
EKG to screen for cardiac arrhythmias. The cost of this test will be covered by the 
university of Mississippi Departments of Anesthesiology and Psychiatry. Any 
rhythm other than sinus rhythm will result in exclusion from the study. 
 
The patient’s length of hospital stay will be recorded. Patients will be called at 
three and six months post-discharge to assess for any adverse events or 
medication reactions. Readmission rates will be assessed at six months post-
discharge. 
Inclusion Criteria 
1. Men and women between the ages of 18 and 64 
2. Patients admitted to the UMMC inpatient psychiatry service with suicidal 
ideations 
 
Exclusion Criteria 
 
 
1. Lifetime history of schizophrenia or other primary psychotic disorder 
2. Current psychotic or manic symptoms 
3. Substance use disorder within one month of admission 
4. Positive urine toxicology at admission 
5. Any lifetime abuse of ketamine or phencyclidine 
6. Systolic BP >180 mmHg or diastolic BP >110 mmHg  
7. Any patient who has eaten food within 8 hours prior to receiving the 
ketamine infusion or who has drank clear liquids within 2 hours prior to 
receiving the infusion 
8. Known CNS mass 
9. CNS abnormalities 
10. Hydrocephalus 
11. Glaucoma 
12. Acute globe injury 
13. Porphyria 
14. Untreated thyroid disease 
15. Known coronary artery disease with poor functional capacity 
16. Pregnancy 
17. Currently breast-feeding 
18. Abnormal EKG 
Number of Subjects 
(anticipated) 
100 (50 in the control group, 50 in the treatment group) 
 
Outcome Measures 
 
 
The primary outcome will be the number of hours a patient is admitted to the 
inpatient psychiatry service after receiving the infusion. A secondary outcome will 
be improvement in their Scale of Suicidal Ideation score. 


Page 6 of 7 
 
Study Endpoints 
 
 
The study will end upon a patient’s discharge orders from the inpatient 
psychiatry ward being signed in Epic. Patients will be encouraged to notify their 
nurse when they feel they are ready for discharge, and subsequently will be 
evaluated by a psychiatrist to determine if they improved significantly enough to 
leave the inpatient facility. 
Private Health 
Information 
 
 
The PHI that will be accessed includes the entire patient's medical record within 
Epic. The only PHI that will be collected is the patient's length of hospital stay. All 
private health information will be stored on a password-protected USB drive that 
will be stored in a locked filing cabinet in Dr. Kenneth Oswalt's office at UMMC. 
Prior to submitting data for statistical analysis, all medical record numbers will be 
substituted for numerical values ranging from 1 to 100. 
Statistical 
Methodology  
 
 
 
Michelle Tucci, PhD, was consulted to determine the power of our study and 
evaluate for confounding variables. She determined that if a difference in length 
of stay between the treatment and control groups of two days was expected, 
then a treatment group of 50 people would be sufficient to potentially find a 
statistical difference. 


Page 7 of 7 
References  
 
 
 
Ballard, Elizabeth D. et al. Improvement in Suicidal Ideation after Ketamine 
Infusion: Relationship to Reductions in Depression and Anxiety. Journal of 
Psychiatric Research, 58   (2014), 161-166. 
 
Burger, LT John et al. A Double-Blinded, Randomized, Placebo-Controlled Sub-
Dissociative Dose Ketamine Pilot Study in the Treatment of Acute Depression and 
Suicidality in a Military Emergency Department Setting. Military Medicine, 181, 
10: 1195, 2016. 
 
Fond, G. et al. Ketamine administration in depressive disorders: a systematic 
review and meta-analysis. Psychopharmacology, 231 (2014), 3663-3676. 
 
Lael, Reinstatler and Youssef, Nagy A. Ketamine as a Potential Treatment for 
Suicidal Ideation: A Systemic Review of the Literature. Drugs in R&D, 15 (2015), 
37-43 
 
Lapidus, Kyle A.B. et al. A Randomized Controlled Trial of Intranasal Ketamine in 
Major Depressive Disorder. Biol Psychiatry 2014; 76: 970-976. 
 
Murrough, J.W. et al. Ketamine for rapid reduction of suicidal ideation: a 
randomized controlled trial. Psychological Medicine, 45 (2015), 3571-3580. 
 
Rajkumar, R., Fam, J., Yeo, E.Y.M. and Dawe, G.S. Ketamine and suicidal ideation 
in depression: Jumping the gun? Pharmacological Research, 99 (2015), 23-35. 
 
Serafini, G., Pompili, M., Seretti, M.E., Stefani, H., Palermo, M., Coryell, W., and 
Girardi, P. (2013). The role of inflammatory cytokines in suicidal behavior: A 
systemic review. European Neuropsychopharmacology, 23 (2013), 1672-1686. 
 
Wu, G.J., Chen, T.L., Ueng, Y.F. and Chen, R.M. (2008). Ketamine inhibits tumor 
necrosis factor-alpha and interleukin-6 gene expressions in lipopolysaccharide-
stimulated macrophages through suppression of toll-like receptor 4-mediated c-
Jun N-terminal kinase phosphorylation and activator protein-1 activation. 
Toxicology and Applied Pharmacology, 228, 105-113. 
 
 
 
 
 

ICF_000.pdf: 
1 
 
Ketamine: its effects on suicidal ideations and inpatient 
hospital length of stay. 
 
 
 
NCT02997722 
 
 
 
 
 
11/02/2017 
 
 
 
 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
2
CONSENT TO PARTICIPATE IN RESEARCH 
 
The University of Mississippi Medical Center 
 
Study Title: Ketamine: its effects on suicidal ideations and inpatient hospital 
length of stay 
 
Principal Investigator: Allen Richert, MD 
_____________________________________________________ 
 
Introduction   
 
You are being invited to be in this experimental research study because 
you have been admitted to the hospital for thoughts of suicide. Please take 
your time making a decision and feel free to discuss it with your friends and 
family. Before agreeing to take part in this research study, it is important 
that you read and understand this document that describes the study. 
Please ask the study researcher or the study staff to explain any words or 
information that you do not clearly understand. 
 
Purpose   
 
Previous research studies have shown the drug ketamine can improve 
suicidal thoughts.  Ketamine is a drug used for pain control, but is not 
approved for the treatment of depression or suicidal thoughts. We are 
doing this study to learn about ketamine and its effects on depression and 
thoughts of suicide.  We also hope to learn if the drug affects the length of 
the hospital stay. 
 
Procedures 
If you agree to participate in this study, your participation will begin within 
24 hours of being admitted to the hospital. After a member of the study 
team ensures that you understand the risks and benefits of participating 
versus not participating, you will be assigned, by chance, to one of the 
following groups: 
 
 Group A: receives ketamine intravenous (IV) infusion over 45 minutes 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
3
 Group B: receives saline (salt solution) over 45 minutes 
 
After receiving your infusion, you will be monitored for an additional 30 
minutes by medical personnel in either the Post-Anesthesia Care Unit 
(PACU) or Short Stay Procedure Area (SSPA). Neither you, nor your study 
doctor, will know what group you are in. While receiving the infusion, your 
vital signs (including heart rate, heart rhythm, blood pressure, respiratory 
rate, and temperature) will be monitored on an anesthesia paper chart. 
After you are discharged from the hospital, the treatment team will analyze 
your medical record and compare the length of your hospital stay with 
others who participated in the study. The only information about your 
hospital stay that will be analyzed will be the length of your hospital stay. 
 
If you are a woman of childbearing age, a urine pregnancy test will be 
performed after you agree to enroll in the study. All participants will also 
require an EKG. The cost of these tests will be covered by the University of 
Mississippi Departments of Anesthesiology and Psychiatry.  If you are 
found to be pregnant or to have an abnormal heart rhythm, you will not be 
able to participate in the study. 
 
Length of Participation 
 
Your participation in this study will last until you are discharged from the 
hospital. You will receive a phone call three months after discharge, and 
again at six months after discharge to assess for any adverse medication 
reactions. 
 
Risks of Ketamine 
 
Less Likely: 
 High blood pressure which may cause heart attack or stroke 
 Racing heart beat 
 Double vision 
 Hallucinations 
 Confusion 
 
Rare: 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
4
 Slowed heart beat 
 Throat spasms 
 Low blood pressure 
 Allergic reaction which may cause rash or shortness of breath 
 Increased pressure in the eye which may cause vision changes 
 Pressure in the space between the brain and the skull which may 
lead to headaches, nausea/vomiting, and vision changes 
 
We do not know how your body might respond to the medications used in 
this study.  We will discuss the risks identified above with you and the 
chances that they will happen.  There may be risks that we do not know 
about at this time.  Unknown problems, ranging from a mild inconvenience 
to some severe enough to cause stroke or heart attack may occur.  If you 
experience any of the above-mentioned symptoms, please call the 
University of Mississippi Medical Center at 601-984-1001 and ask for Dr. 
Allen Richert, the principal investigator, or the person on-call for him. 
 
Pregnancy  
 
You may not be pregnant, trying to become pregnant, or breastfeeding a 
baby while taking part in this research study.  Urine pregnancy tests will be 
done on all women of childbearing potential.  
 
Benefits   
 
You may or may not receive a direct benefit from being in this research 
study. Previous studies have shown that ketamine may improve depression 
and suicidal thoughts, and therefore shorten the length of hospital stay. 
However, there may not be any difference at all in your situation. We hope 
to learn information that may help others in the future. 
 
Alternatives 
 
The alternative is not to participate. The study drug is experimental. This 
means you can only receive it by enrolling in this study. 
 
Costs 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
5
 
There will not be additional costs to you if you participate in this study. 
University of Mississippi Medical Center Departments of Anesthesiology 
and Psychiatry will supply the study drug, EKG, and urine pregnancy test (if 
applicable) at no cost to you. Insurance companies and other third party 
payers will not be billed for research procedures. 
 
The medical care that you will receive while in this study is considered 
standard care for your situation and would be recommended whether or not 
you participate in this study.  These costs will be billed to you or your 
insurance carrier. 
 
Research-related injury 
 
In the case of injury or illness resulting from your participation in this study, 
medical treatment is available to you at the University of Mississippi 
Medical Center.  You will be charged the usual and customary charges for 
any such treatment you receive.  
 
Compensation 
 
You will not be paid for participating in this study. 
 
Voluntary Participation  
 
Your participation is voluntary.  If you decide not to participate in this study 
you will not suffer a penalty or loss of benefits to which you are otherwise 
entitled.  
 
Withdrawal 
 
You may choose to stop your participation in this study at any time. If you 
decide to withdraw the information already collected about you may still be 
used in this study but additional information will not be collected.  Your 
decision to stop your participation will have no effect on the quality of 
medical care you receive at the University of Mississippi Medical Center. 
Please talk to us about this decision to help ensure your safe withdrawal 
from the study. 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
6
 
 
 
 
New Information 
 
You will be told of any information we learn during your participation in this 
study that may affect your willingness to participate.   
 
Confidentiality 
 
Every effort will be made to keep the information we learn about you 
private.  Study personnel, the Food and Drug Administration (FDA), the 
Office for Human Research Protections (OHRP), the University of 
Mississippi Medical Center’s Institutional Review Board (IRB) and Office of 
Integrity and Compliance may review the study records. If study results are 
published your name will not be used.   
 
A copy of this informed consent document will be filed in your medical 
record because the experimental research you are agreeing to participate 
in involves your care, diagnosis, or treatment. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This Web site will not include information that can 
identify you.  At most, the Web site will include a summary of the results. You can 
search this Web site at any time. 
 
Protected Health Information 
 
Protected health information is any personal health information through 
which you can be identified. The information collected in this study will be 
the type of infusion you receive, your medical record number, and the 
length of your hospitalization. Your name, age, and date of birth will not be 
recorded. By signing this consent document, you authorize Dr. Richert to 
collect this information and use your records as necessary for this study.  
 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
7
The information collected for this study will be kept indefinitely and may be 
combined with information collected through other research studies or used 
in other studies but no information will identify you.   
 
You have the right to cancel this authorization at any time by providing Dr. 
Richert with a written request to cancel the authorization.  If you cancel this 
authorization, medical information and records about you that were created 
before the authorization was cancelled will still be used and disclosed as 
needed to preserve the integrity of the study. 
 
This authorization has no expiration date. If you do not sign this consent 
document, you will not be allowed to participate in this study. 
 
Number of Participants 
 
We expect 100 participants to enroll in this study here at the University of 
Mississippi Medical Center. 
 
Questions 
 
If you have questions about this study or need to report any problems, side 
effects, or injuries, please call the call the University of Mississippi Medical 
Center at 601-984-1001 and ask to be connected to Dr. Allen Richert, the 
principal investigator, or the person on-call for him. 
 
You may discuss your rights as a research participant with the Chairman of 
the University of Mississippi Medical Center’s Institutional Review Board, 
2500 North State Street, Jackson, Mississippi, 39216; telephone: 601-984-
2815; facsimile, 601-984-2961.  The Institutional Review Board is a group 
of people not involved with this study who have reviewed the study to 
protect your rights.  
 
You will be given a copy of this consent document after it has been signed. 
 
Statement of Participation 
 
I have been told about this study, including the experimental treatment I will 
receive, and the possible risks and benefits.  I agree to participate in this 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
8
study, to follow instructions, and to report any side effects to my study 
doctor.  My participation is voluntary and I may withdraw at any time 
without any penalty or loss of benefits to which I am entitled, including 
medical care at the University of Mississippi Medical Center. 
 
By signing this form, I am not giving up any legal rights I may have.   
 
 
________________________________ 
Participant’s Printed Name 
 
________________________________ 
Participant’s Signature 
 
____________________________ 
Date 
 
 
 
_____________________________________________________________ 
Printed Name of Legally Authorized Representative and relationship to 
participant (if applicable) 
 
______________________________________________ 
Signature of Legally Authorized Representative (if applicable) 
 
___________________________________ 
Date 
 
 
 
_________________________________________ 
Printed Name of Person Obtaining Consent 
 
 
__________________________________________ 
Signature of Person Obtaining Consent 
 


 
“Ketamine: its effects on suicidal ideations  
and inpatient hospital length of stay” 
      Principal Investigator: Allen Richert, MD 
      Version 14; Revised November 2, 2017 
9
 
________________________________ 
Date 
 
 
 
I acknowledge that the participant identified above has been entered into 
this study, with properly obtained informed consent. 
 
________________________________ 
Signature of Principal Investigator  
 
________________________________ 
Date