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NCT05227612 · ClinicalTrials.gov registry record · Phase 1
Psilocybin-assisted CBT for Depression
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05227612: Completed Phase 1 study, sponsored by University of California, Los Angeles.
NCT05227612 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05227612, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
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 will involve an open trial of PA-CBT where participants will receive two doses of psilocybin (10mg and then 25mg, separated by one month) plus 12 sessions of cognitive behavioral therapy.
Primary Outcome
Participant feedback related to the treatment on the Client Satisfaction Questionnaire-8. Scores can range from 8-32 with higher scores indicating greater satisfaction.
Interventions
- DRUG Psilocybin
- BEHAVIORAL Cognitive behavioral therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 1 |
What the finished NCT05227612 record still lists
NCT05227612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Psilocybin is the first listed.
NCT05227612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05227612 about?
NCT05227612 is a clinical study titled "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 NCT05227612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-06-27. Estimated completion is 2025-09-12.
What interventions are being tested in trial NCT05227612?
The interventions under investigation include: Psilocybin (DRUG), Cognitive behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05227612?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05227612's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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