Clinical trial NCT02997722: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Suicidal Ideation
Keywords: ketamine
suicidal ideation
length of stay
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inpatient Hospital Length of Stay
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Allen C Richert, MD
role: PRINCIPAL_INVESTIGATOR
References: