Group PACBT for Depression

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT07566104
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cognitive Behavioral Therapy
  • Depression - Major Depressive Disorder
  • Psilocybin

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (drug) — DRUG
    Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later)
  • Group Cognitive Behavioral Therapy — BEHAVIORAL
    12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023)

Study Details

This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.

Key Dates

Start date
Jan 31, 2027
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group PACBT
    12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously

Primary Outcome Measure

Treatment acceptability [ Time Frame: 4 months (Baseline to Post-treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Semel InstituteLos AngelesCalifornia90095
Shelby Grody
[email protected]
3108254354
Marc Weintraub, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA Semel Institute· Los Angeles, CA

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