CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Psilocybin +1 moredrug
Likely dose
Psilocybin 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05227612
NCT05227612Phase 1Completed
CompareCT.gov

Psilocybin-assisted Cognitive Behavioral Therapy for Depression

University of California, Los Angeles·interventional·Posted Feb 7, 2022·Updated May 19, 2026

In Brief

A Phase 1 clinical trial evaluating Psilocybin and Cognitive behavioral therapy for Major Depressive Disorder. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedFeb 7, 2022
Enrollment StartJun 27, 2023
Primary CompletionSep 12, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.4 years ago

Interventions

Psilocybindrug

Participants will receive two doses of psilocybin (10mg, 25mg).

Cognitive behavioral therapybehavioral

Twelve total sessions of therapy, including manualized cognitive behavioral therapy for major depressive disorder, including psychoeducation about depression, cognitive skills, and behavioral skills as well as preparation for psilocybin.