Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPsilocybinCompleted

Psilocybin-assisted CBT for Depression

Phase I/II study (n=62 estimated) testing two fixed psilocybin doses (10 mg then 25 mg, one month apart) combined with either 12-session PA-CBT or 6-session minimal supportive therapy in adults with major depressive disorder to assess feasibility, acceptability and preliminary efficacy.

Target Enrollment
62 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

This study includes a Phase I open trial (n≈12) of psilocybin-assisted CBT (PA-CBT) followed by a Phase II randomized, parallel-group trial (n≈50) comparing PA-CBT (12 sessions) with a minimal supportive therapy condition (6 sessions).

All participants receive two oral psilocybin sessions (10 mg then 25 mg, one month apart). Outcomes include feasibility, acceptability, adherence, and clinical measures of depressive symptoms (HAM-D) and safety assessments.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Psilocybin + CBT

experimental

Two oral psilocybin doses (10 mg then 25 mg, one month apart) combined with 12-session manualised cognitive behavioural therapy (PA-CBT).

Interventions

  • Psilocybin10 - 25 mg
    via Oral• two sessions• 2 doses total

    10 mg then 25 mg, one month apart

  • Compound
    via Other

    Twelve sessions of manualised cognitive behavioural therapy (preparation, integration and CBT skills).

Psilocybin + Minimal supportive therapy

active comparator

Two oral psilocybin doses (10 mg then 25 mg, one month apart) combined with 6 sessions of minimal supportive, non-directive therapy (3 sessions preparation, 3 sessions supportive integration).

Interventions

  • Psilocybin10 - 25 mg
    via Oral• two sessions• 2 doses total

    10 mg then 25 mg, one month apart

  • Compound
    via Other

    Six sessions: 3 preparation sessions (including ~3 hours preparation) and 3 hours supportive integration after dosing; non-directive supportive therapy.

Participants

Ages
21 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Ages 21-60
  • Able to swallow capsules
  • Current major depressive episode or history of major depressive episodes based on DSM-5 criteria
  • Active current depressive symptoms (HAM-D >16 covering the prior 2 weeks)
  • Identified support person able to pick up participant from UCLA Semel Institute and drive them home after psilocybin sessions
  • Women of child-bearing potential using one form of highly effective contraception and willing to continue contraceptive use for duration of study
  • Medically cleared for the study by a physician

Exclusion Criteria

  • Exclusion Criteria:
  • A personal or family history (first or second-degree) of psychosis or bipolar disorder
  • Resting blood pressure above 140/90 mmHg (averaged across four separate measurements)
  • Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial)
  • 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, 5-HTP)
  • Currently receiving cognitive behavioural 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
  • 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 the prior 6 months
  • Positive urine drug screen for illicit substances
  • Use of other psychedelics or ketamine within the prior 12 months
  • Adverse prior reaction to a psychedelic agent
  • Pregnant, trying to get pregnant, or nursing

Study Details

Locations

UCLA Semel Institute — Los Angeles, California, United States

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