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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02997722
Other study ID # 2016-0107
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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