CompletedPhase 1

Psilocybin-assisted CBT for Depression

United States16 participantsStarted 2023-06-27

Plain-language summary

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.

Who can participate

Age range

21 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 car…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This was a Phase 1 trial of psilocybin combined with CBT for major depression that has already completed — what do the early results suggest about safety and tolerability, and how does the fact that it was a Phase 1 study limit what we can conclude about whether it actually works?
2The trial measured whether patients completed a 4-month treatment program as a sign of feasibility — given how demanding a 4-month psilocybin-assisted CBT program likely is, do you think that kind of commitment would be realistic for my situation?
3Since this trial is now completed and was an early-phase study, do you know if there are follow-on Phase 2 or Phase 3 trials building on this research that might be worth looking into, or would standard treatments for my depression be a more evidence-backed starting point right now?
4The trial used the Hamilton Depression Rating Scale and the Global Assessment of Functioning to measure outcomes — based on where I currently score on measures like these, would I have been the kind of patient this trial was designed to study, and what does that tell us about whether this approach might be relevant to my case?
5Psilocybin is a controlled substance with psychological risks — given my personal health history, are there any reasons you'd be especially cautious about me even exploring psilocybin-assisted therapy options, whether in a trial or eventually in a clinical setting?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Acceptability (Client Satisfaction Questionnaire-8)

Timeframe: 4-month treatment period

Study Feasibility (Number of Participants That Completed the 4-month Treatment)

Timeframe: 4-month treatment period

Hamilton Depression Rating Scale (HAM-D)

Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)

Global Assessment of Functioning (GAF)

Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)

Trial details

NCT IDNCT05227612

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-12

Results submitted2026-04-07

View on ClinicalTrials.gov More Major Depressive Disorder trials

Plain-language summary

Who can participate

Age range

21 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment Acceptability (Client Satisfaction Questionnaire-8)

Timeframe: 4-month treatment period

Study Feasibility (Number of Participants That Completed the 4-month Treatment)

Timeframe: 4-month treatment period

Hamilton Depression Rating Scale (HAM-D)

Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)

Global Assessment of Functioning (GAF)

Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)