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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02461927
The ClinicalTrials.gov registry entry for NCT02461927 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ketamine + Naltrexone is the first listed.
NCT02461927 reports 0 study locations.
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.
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