The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.

Study Overview
=================
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.

Official Title
-----------------
Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay

Conditions
-----------------
Suicidal Ideation

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between the ages of 18 and 64 Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations Exclusion Criteria: Lifetime history of schizophrenia or other primary psychotic disorder Current psychotic or manic symptoms Substance use disorder within one month of admission Positive urine toxicology at admission Any lifetime abuse of ketamine or phencyclidine Systolic BP >180 mmHg or diastolic BP >110 mmHg 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 Known central nervous system (CNS) mass CNS abnormalities Hydrocephalus Glaucoma Acute globe injury Porphyria Untreated thyroid disease Known coronary artery disease with poor functional capacity Pregnancy Currently breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine infusion<br>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes. | Drug: Ketamine<br>* IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.<br>|
| Placebo Comparator: Normal Saline infusion<br>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes. | Drug: Normal Saline<br>* IV infusion of 100 ml of normal saline over 45 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient Hospital Length of Stay | We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient. | The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, suicidal ideation, length of stay