Actively Recruiting
RCT of Psilocybin-assisted CBT for Depression
Led by University of California, Los Angeles · Updated on 2026-02-12
50
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
RCT of Psilocybin-assisted CBT for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 21 to 60 years
- Able to swallow capsules
- Patients with a current or past major depressive episode based on DSM-5 criteria
- Active current depressive symptoms with scores above 16 on the Hamilton Depression Rating Scale
- Have an identified support person to drive participant home after psilocybin sessions
- Women of child-bearing potential must use highly effective contraception and agree to continue during the study
- Medically cleared for the study by a physician
You will not qualify if you...
- Personal or family history of psychosis or bipolar disorder
- Resting blood pressure above 140 systolic or 90 diastolic averaged over four measurements
- Diagnosis of DSM-5 cluster B personality disorder
- Active suicidality or psychiatric disturbance requiring acute treatment
- Current use of antidepressants or other serotonergic substances
- Currently receiving cognitive behavioral therapy
- Cardiovascular conditions including uncontrolled hypertension, heart disease, or significant ECG abnormalities
- History of stroke or transient ischemic attack
- Epilepsy or history of seizures
- Insulin-dependent diabetes
- Substance abuse or dependence within past 6 months
- Positive urine drug screen for illicit substances
- Use of other psychedelics or ketamine within past 12 months
- Prior adverse reaction to a psychedelic agent
- Pregnant, trying to get pregnant, or nursing
AI-Screening
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Trial Site Locations
Total: 1 location
1
UCLA Semel Institute
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
S
Shelby Grody
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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