Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT07226232
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Major Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Psilocybin comparator dose
  • Psilocybin — DRUG
    Psilocybin Intervention Dose

Study Details

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.

Key Dates

Start date
Jul 30, 2026
Status verified
Jun 2026
Primary completion
Dec 2, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Psilocybin comparator dose
  • Experimental: Intervention
    Psilocybin intervention dose

Primary Outcome Measure

Montgomery-Asberg Rating Scale (MADRS) [ Time Frame: 2 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Lori L Davis, MD AB
[email protected]
(205) 554-3819
Anchal Ghera, MS
[email protected]
(205) 899-1273
Lori Lynne Davis, MD AB (PRINCIPAL_INVESTIGATOR)
Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosaAlabama35404-5015
Patricia Pilkinton, MD
[email protected]
205-554-2000
Kaleb Murry, MS
[email protected]
2055542000
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Christopher Stauffer, MD
[email protected]
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
Michael Thase, MD
[email protected]
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Rebecca Hendrickson, MD
[email protected]

Find similar trials in Birmingham, AL

By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALTuscaloosa VA Medical Center, Tuscaloosa, AL· Tuscaloosa, ALVA Portland Health Care System, Portland, OR· Portland, ORCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA· Philadelphia, PAVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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