Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
Phase: PHASE4
Conditions: Suicidal Ideation
Sponsor: Allen Richert

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Ketamine: its effects on suicidal ideations and 
inpatient hospital length of stay. 
 
 
 
NCT02997722 
 
 
 
 
 
11/06/2017 
 
 
 
 

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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. 

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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? 

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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. 
 

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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. 

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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. 

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References  
 
 
 
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