Group PACBT for Depression

Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.

Study Overview

• Status: Not yet recruiting
• Conditions: Psilocybin; Cognitive Behavioral Therapy; Depression - Major Depressive Disorder
• Intervention / Treatment: Drug: Psilocybin (drug); Behavioral: Group Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute
      • Principal Investigator: Marc Weintraub, PhD
      • Contact: Shelby Grody; Phone Number: 3108254354; Email: UCLAPAT@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 21-60,
• Fluent in English
• Able to swallow capsules,
• Meets for 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 covering the prior 2 weeks; Hamilton, 1986),
• Have an identified support person (i.e., trusted adult friend or relative) 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. Must be willing to take on-site pregnancy tests.
• Agree to refrain from any psychoactive drug (including alcohol) within 24 hours of each drug session and during the drug sessions. Participants will be allowed to consume their usual amount of caffeine prior to and after the drug sessions.
• Agree to not take any PRN medications on the mornings of the drug sessions
• Has been medically cleared for the study by a physician
• Participants must remain on anti-hypertensive medications if prescribed previously to manage hypertension

Exclusion Criteria:

• A personal or family history (first-degree) of psychosis or mania
• Resting blood pressure above 140 systolic, 90 diastolic or heart rate > 90 beats per minute (averaged across four separate measurements)
• Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
• Active suicidality (i.e., HAM-D item 3 score of greater than 3) 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), lithium, or efavirenz [regardless of whether the drug(s) is/are prescribed for MDD or other conditions]
• Current use of opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)
• 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
• QTc interval measurement of > 450 ms in males or > 460 ms in females as measured by the baseline ECG
• 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 (including for nicotine and cannabis)
• Positive urine drug screen for illicit substances (not including cannabis)
• Use of other psychedelics or ketamine within prior 12 months
• Adverse prior reaction to a 5-HT2A receptor agonist psychedelic agent
• Pregnant, trying to get pregnant, or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group PACBT; 12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously	Drug: Psilocybin (drug); Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later); Behavioral: Group Cognitive Behavioral Therapy; 12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment acceptability	Treatment acceptability as measured by the participant on the Client Satisfaction Questionnaire-8. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.	4 months (Baseline to Post-treatment)
Feasibility as measured by participant retention	Participant retention over the treatment	4 months
Hamilton Depression Rating Scale	Depressive symptom severity scored from 0-53, with larger values indicating greater depressive severity	7 months (Baseline to end of study)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: group treatment
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Indoles; Indole Alkaloids; Indolizidines; Indolizines; Tryptamines; Psilocybin; Pharmaceutical Preparations
• Other Study ID Numbers: 25-0602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No