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

Primary Purpose

Suicidal Ideation

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Normal Saline

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring ketamine, suicidal ideation, length of stay

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine infusion

Normal Saline infusion

Arm Description

Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.

Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02997722

First Posted

December 15, 2016

Last Updated

May 18, 2020

Sponsor

Allen Richert

1. Study Identification

Unique Protocol Identification Number

NCT02997722

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Staffing and space deficiencies prevented completion of the study.

Study Start Date

March 2, 2017 (Actual)

Primary Completion Date

May 19, 2017 (Actual)

Study Completion Date

May 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Allen Richert

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicidal Ideation

Keywords

ketamine, suicidal ideation, length of stay

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine infusion

Arm Type

Experimental

Arm Description

Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.

Arm Title

Normal Saline infusion

Arm Type

Placebo Comparator

Arm Description

Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Intervention Description

IV infusion of 100 ml of normal saline over 45 minutes.

Primary Outcome Measure Information:

Title

Inpatient Hospital Length of Stay

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen C Richert, MD

Organizational Affiliation

University of Mississippi Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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