Psilocybin-assisted CBT for Depression
Trial Summary
What is the purpose of this trial?
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 has two phases. Phase I 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. Phase II will be 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).
Will I have to stop taking my current medications?
Yes, you will need to stop taking antidepressants or other medications that affect serotonin, like St. John's Wort, to participate in this trial.
What data supports the effectiveness of the drug psilocybin for depression?
Is psilocybin generally safe for human use?
How is psilocybin-assisted CBT for depression different from other treatments?
Psilocybin-assisted CBT for depression is unique because it combines the psychedelic effects of psilocybin, which can rapidly reduce depression symptoms, with cognitive behavioral therapy (CBT), a structured talk therapy. This combination aims to enhance the therapeutic process by potentially opening new perspectives and emotional insights during therapy sessions.19101112
Eligibility Criteria
This trial is for adults aged 21-60 with depression, who are experiencing a major depressive episode. They must be able to swallow capsules and have someone to drive them home after sessions. Women should use effective contraception. Exclusions include active suicidality, current antidepressant use, certain cardiovascular conditions, insulin-dependent diabetes, history of psychosis or bipolar in the family, prior adverse reaction to psychedelics, pregnancy or nursing.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Open trial of PA-CBT with two doses of psilocybin (10mg and 25mg) and 12 sessions of cognitive behavioral therapy
Phase II Treatment
Randomized trial with two arms: 12-session PA-CBT or 6-session standard psilocybin-assisted therapy, both with two doses of psilocybin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator