RecruitingPhase 1Phase 2NCT07281352

RCT of Psilocybin-assisted CBT for Depression

Psilocybin-Assisted Cognitive Behavioral Therapy for Depression

Sponsor

University of California, Los Angeles

Enrollment

50 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Major Depressive Diorder

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).

Eligibility

Min Age: 21 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining psilocybin (a compound found in certain mushrooms) with cognitive behavioral therapy (a structured talk therapy) is effective for treating depression. **You may be eligible if...** - You are between 21 and 60 years old - You are able to swallow capsules - You have been diagnosed with major depression (current episode or history of episodes) based on standard diagnostic criteria - You currently have active depression symptoms (score above 16 on a standard depression rating scale) - You have someone who can drive you home after psilocybin sessions - If you can become pregnant, you are using an effective form of contraception and agree to continue it for the study - A doctor has medically cleared you to participate **You may NOT be eligible if...** - You do not meet the medical clearance requirements - You are unable to arrange a designated driver for session days - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin (drug)

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

BEHAVIORALcognitive behavioral therapy

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.

BEHAVIORALMinimal supportive therapy

Six total therapy sessions. Preparation for psilocybin in the first three sessions plus supportive, nondirective psychotherapy in the final three sessions.

Locations(1)

UCLA Semel Institute

Los Angeles, California, United States

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NCT07281352

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