Psilocybin plus cognitive behavioral therapy for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, two-arm Phase 1/2 trial gives all participants two fixed doses of psilocybin (10 mg then 25 mg one month apart) and compares a 12-session psilocybin‑assisted CBT program to a shorter 6‑session psilocybin‑assisted supportive therapy condition. The study will measure feasibility, acceptability, and adherence for both participants and therapists while collecting clinical outcome data on depressive symptoms. Phase II participants are randomized 1:1 to the longer PA‑CBT protocol or the standard supportive psilocybin-assisted therapy (3 hours of preparation plus 3 hours of post‑session integration). The protocol includes required in-person dosing visits at UCLA with a support person to escort participants home after sessions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 21-60,

  * Able to swallow capsules,
  * Patients with a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),
  * Active current depressive symptoms (i.e., scores \>16 on the Hamilton-Depression Rating Scale (HAM-D) covering the prior 2 weeks; Hamilton, 1986),
  * Have an identified support person who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,
  * For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study
  * Patient has been medically cleared for the study by a physician.

Exclusion Criteria:

* A personal or family history (first or second-degree) of psychosis or bipolar disorder

  * Resting blood pressure above 140 systolic, 90 diastolic (averaged across four separate measurements)
  * Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
  * Active suicidality (as indicated by a 3 or greater on item 3 of the HAM-D) or other psychiatric disturbance requiring acute treatment
  * Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan),
  * Currently receiving cognitive behavioral therapy,
  * Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
  * A history of stroke or Transient Ischemic Attack (TIA)
  * Epilepsy or history of seizures
  * Insulin-dependent diabetes
  * Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months
  * Positive urine drug screen for illicit substances
  * Use of other psychedelics or ketamine within prior 12 months
  * Adverse prior reaction to a psychedelic agent
  * Pregnant, trying to get pregnant, or nursing

Where it's running

• UCLA Semel Institute
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Shelby Grody
• Email: UCLAPAT@mednet.ucla.edu
• Phone: 310-825-4354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.