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Group PACBT for Depression

NCT07566104 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Depression - Major Depressive Disorder
  • Psilocybin
  • Cognitive Behavioral Therapy

Interventions

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)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566104 on ClinicalTrials.gov