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NCT02461927 · ClinicalTrials.gov registry record · Phase 1
Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT02461927: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT02461927 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02461927, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. The 4-month follow-up session will also occur.
Primary Outcome
Our primary analysis (severity of depression) was to compare the proportions of subjects with clinical response in symptoms of major depressive disorder (response defined as a 50% or greater improvement from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores) at the end-of-treatment time point (Day 21, after 4th infusion, T+240 minutes).
Interventions
- DRUG Ketamine + Naltrexone
- DRUG Ketamine + Placebo
- DRUG Placebo (psychoactive placebo midazolam) + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 1 |
What the finished NCT02461927 record still lists
NCT02461927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Ketamine + Naltrexone is the first listed.
NCT02461927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02461927 about?
NCT02461927 is a clinical study titled "Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder". The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind ...
What is the current status of trial NCT02461927?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2015-01-01. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT02461927?
The interventions under investigation include: Ketamine + Naltrexone (DRUG), Ketamine + Placebo (DRUG), Placebo (psychoactive placebo midazolam) + Placebo (DRUG).
Who is sponsoring clinical trial NCT02461927?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02461927's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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