RCT of Psilocybin-assisted CBT for Depression

Conditions

• Major Depressive Diorder

Eligibility Criteria

Sex

ALL

Age

21 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Psilocybin (drug) — DRUG
  Participants will receive two doses of psilocybin (10mg, 25mg).
• cognitive behavioral therapy — BEHAVIORAL
  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.
• Minimal supportive therapy — BEHAVIORAL
  Six total therapy sessions. Preparation for psilocybin in the first three sessions plus supportive, nondirective psychotherapy in the final three sessions.

Study Details

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).

Key Dates

Start date

Jan 5, 2026

Status verified

Dec 2025

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental: Psilocybin + CBT
  Participants will receive 12 sessions of cognitive-behavioral therapy (CBT) along with two psilocybin-drug sessions -- the first following the third CBT session (10mg of psilocybin, taken orally) and the second following the sixth CBT session (25mg of psilocybin, taken orally).
• Active Comparator: Psilocybin + Minimal supportive therapy
  Participants will receive 6 sessions of supportive, non-directive therapy along with two psilocybin-drug sessions -- the first following the third therapy session (10mg of psilocybin, taken orally) and the second following the fourth therapy session (25mg of psilocybin, taken orally).

Primary Outcome Measure

Client Satisfaction Questionnaire - 8 [ Time Frame: 4-month treatment period ]

Central Contacts

• Shelby Grody
  310-825-4354
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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