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Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

NCT07226232 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-11-10

No results posted yet for this study

Summary

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

Conditions

Interventions

DRUG

Psilocybin

Psilocybin comparator dose

DRUG

Psilocybin

Psilocybin Intervention Dose

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Lori Lynne Davis, MD AB · Birmingham VA Medical Center, Birmingham, AL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2030-12-02
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT07226232 on ClinicalTrials.gov