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

Phase 4

Terminated

• Conditions: Suicidal Ideation
• Interventions: Drug: Normal Saline; Drug: Ketamine

• Registration Number: NCT02997722
• Lead Sponsor: Allen Richert

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2017-03-02
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19
• Results First Submitted: 2020-04-16
• Results First Submitted QC: 2020-04-16
• Results First Posted: 2020-04-29
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline infusion	Normal Saline	Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
Ketamine infusion	Ketamine	Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.

Primary Outcome Measures

Name	Time	Method
Inpatient Hospital Length of Stay	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.	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.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States