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NCT07281352 · ClinicalTrials.gov registry record · Phase 1
RCT of Psilocybin-assisted CBT for Depression
A Phase 1 study of Major Depressive Diorder, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07281352: Recruiting Phase 1 study of Major Depressive Diorder, sponsored by University of California, Los Angeles.
NCT07281352 is a Phase 1 study of Major Depressive Diorder that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07281352, a Phase 1 study of Major Depressive Diorder, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).
Primary Outcome
Treatment acceptability as measured by the participant. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Conditions Studied
Interventions
- BEHAVIORAL cognitive behavioral therapy
- DRUG Psilocybin (drug)
- BEHAVIORAL Minimal supportive therapy
Study Locations (1)
California
- UCLA Semel Institute - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What NCT07281352 shows while recruiting
NCT07281352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Major Depressive Diorder appearing as the primary indexed condition, and to 3 interventions - of which cognitive behavioral therapy is the first listed.
NCT07281352 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07281352 about?
NCT07281352 is a clinical study titled "RCT of Psilocybin-assisted CBT for Depression". The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with p...
What is the current status of trial NCT07281352?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2026-01-05. Estimated completion is 2027-11-30.
What conditions does trial NCT07281352 study?
This clinical trial studies the following conditions: Major Depressive Diorder.
What interventions are being tested in trial NCT07281352?
The interventions under investigation include: cognitive behavioral therapy (BEHAVIORAL), Psilocybin (drug) (DRUG), Minimal supportive therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT07281352?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07281352 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
How this trial's enrollment target compares
Where NCT07281352's enrollment target sits among peer trials
50 974th of 2000 higher than 984 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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