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NCT04116528 · ClinicalTrials.gov registry record · Phase 3
Opiate Suicide Study in Patients With Major Depression
A Phase 3 study of Major Depressive Disorder, sponsored by Stanford University.
- Active
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04116528: Active Phase 3 study of Major Depressive Disorder, sponsored by Stanford University.
NCT04116528 is a Phase 3 study of Major Depressive Disorder that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 60 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04116528, a Phase 3 study of Major Depressive Disorder, is active but no longer recruiting, sponsored by Stanford University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete. 60 subjects (60 infusions) or approximately 24 infusions per year.
Primary Outcome
Analyses included a modified intention-to-treat population, defined as all randomized participants who received one week of treatment and completed the week 1 assessment of buprenorphine or placebo. A linear mixed-effects model tested the primary hypothesis of efficacy, measured by change in SSI total scores. The model included random effects for patient and fixed effects for treatment group, time as a continuous variable (days of study: 1, 3, 10, 17, 24, 31), and the time-by-treatment group int
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Placebo oral tablet
- DRUG Buprenorphine
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 3 |
What the registry record for NCT04116528 still lists
NCT04116528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Ketamine is the first listed.
NCT04116528 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04116528 about?
NCT04116528 is a clinical study titled "Opiate Suicide Study in Patients With Major Depression". To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete. 60 subjects (60 infusions) or approximately 24 in...
What is the current status of trial NCT04116528?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2020-08-01. Estimated completion is 2026-07-01.
What conditions does trial NCT04116528 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04116528?
The interventions under investigation include: Ketamine (DRUG), Placebo oral tablet (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT04116528?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04116528 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04116528's enrollment target sits among peer trials
60 168th of 282 higher than 111 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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