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

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

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.

Study Overview

• Status: Terminated
• Conditions: Suicidal Ideation
• Intervention / Treatment: Drug: Ketamine; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women between the ages of 18 and 64
2. Patients admitted to the University of Mississippi Medical Center 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 central nervous system (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ketamine infusion; Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.	Drug: Ketamine; IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
PLACEBO_COMPARATOR: Normal Saline infusion; Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.	Drug: Normal Saline; IV infusion of 100 ml of normal saline over 45 minutes.

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.

Collaborators and Investigators

• Sponsor: Allen Richert
• Investigators: Principal Investigator: Allen C Richert, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): May 19, 2017
• Study Completion (ACTUAL): May 19, 2017

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ketamine; suicidal ideation; length of stay
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2016-0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No