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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive two doses of psilocybin (10mg, 25mg).
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.
UCLA Semel Institute
Los Angeles, California, United States
Treatment acceptability
participant and clinician feedback related to the joining of psilocybin with CBT
Time frame: 4-month treatment period
Treatment feasibility
recruitment and retention of participants in the trial
Time frame: 4-month treatment period
Hamilton Depression Rating Scale
symptom severity scored from 0-53, with larger values indicating greater depressive severity
Time frame: 7-month study period
Global Assessment of Functioning
psychosocial functioning scored from 0-100, with larger values indicating better functioning
Time frame: 7-month study period
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