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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04116528
The ClinicalTrials.gov registry entry for NCT04116528 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (84% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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