NCT02461927View on ClinicalTrials.gov

Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

October 30, 2023

Study Completion Date

October 30, 2023

Conditions
Major Depressive DisorderAlcohol Use Disorder
Interventions
DRUG

Ketamine + Naltrexone

Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).

DRUG

Ketamine + Placebo

Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).

DRUG

Placebo (psychoactive placebo midazolam) + Placebo

Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).

Trial Locations (1)

06516-2770

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT02461927 - Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder | Biotech Hunter | Biotech Hunter