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Completed

NCT Number: NCT05227612

Psilocybin-assisted CBT for Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

Participants will receive two doses of psilocybin (10mg, 25mg).

Cognitive behavioral therapy

Behavioral

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.

Primary outcomes

  1. Treatment Acceptability (Client Satisfaction Questionnaire-8)

    Time frame: 4-month treatment period

    Participant feedback related to the treatment on the Client Satisfaction Questionnaire-8. Scores can range from 8-32 with higher scores indicating greater satisfaction.

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

    Time frame: 4-month treatment period

    Retention of participants in the trial

  3. Hamilton Depression Rating Scale (HAM-D)

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

    Symptom severity scored from 0-53, with larger values indicating greater depressive severity, as measured repeatedly at the baseline assessment

  4. Global Assessment of Functioning (GAF)

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

    psychosocial functioning scored from 0-100, with larger values indicating better functioning

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Psilocybin-assisted Cognitive Behavioral Therapy for Depression

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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