Psilocybin-assisted CBT for Depression

Last updated: February 19, 2025
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

1

Condition

Depression

Affective Disorders

Mood Disorders

Treatment

Minimal therapeutic support

Psilocybin

Cognitive behavioral therapy

Clinical Study ID

NCT05227612
21-002134
R34AT013077-01
  • Ages 21-60
  • All Genders

Study 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 has two phases. Phase I 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. Phase II will be 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Ages 21-60,

  • Able to swallow capsules,

  • Patients with a current major depressive episode or a history of majordepressive episodes based on the DSM-5 criteria (American PsychiatricAssociation, 2013),

  • Active current depressive symptoms (i.e., scores >16 on the Hamilton-DepressionRating Scale (HAM-D) covering the prior 2 weeks; Hamilton, 1986),

  • Have an identified support person who can pick up the individual from UCLASemel Institute and drive individual home following psilocybin sessions,

  • For women of child-bearing potential - using one form of highly effectivecontraception (e.g., oral contraceptive pill) and willingness to continuecontraceptive use for duration of study

  • Patient has been medically cleared for the study by a physician.

Exclusion

Exclusion Criteria:

  • • A personal or family history (first or second-degree) of psychosis or bipolardisorder

  • Resting blood pressure above 140 systolic, 90 diastolic (averaged across fourseparate 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) orother 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, orany 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 6months

  • 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

Study Design

Total Participants: 62
Treatment Group(s): 3
Primary Treatment: Minimal therapeutic support
Phase: 1
Study Start date:
June 27, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • UCLA Semel Institute

    Los Angeles, California 90095
    United States

    Active - Recruiting

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