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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02997722
• Other study ID #: 2016-0107
• Status: Terminated
• Phase: Phase 4
• Start date: March 2, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: May 2020
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Drug:
• Ketamine
IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
• Normal Saline
IV infusion of 100 ml of normal saline over 45 minutes.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Allen Richert

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.