Psilocybin-Assisted Therapy as a Treatment for Depression

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07582120
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (Usona Institute) — DRUG
    Capsule containing 25 mg of synthetic psilocybin

Study Details

Depression is the leading cause of disability worldwide, affecting an estimated 300 million people. Despite available treatments, response rates remain modest, and treatment resistance is common. Novel treatments are needed that act rapidly, produce lasting effects and work differently than existing antidepressants. In clinical trials, psilocybin has shown promise as a treatment for depression due to its rapid onset of antidepressant effects and sustained benefits. This study will use MRI scanning of the brain and other biological measures (biomarkers) to investigate how psilocybin affects brain activity and psychological flexibility before, during, and after receiving psilocybin in participants with depressive symptoms.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 25mg Open Label dose of synthetic psilocybin

Primary Outcome Measure

Characterize ACUTE (~1 week post-dose) and PERSISTING (~30 days post-dose) effects of PAT in depressed adults at two possible administrations on depression symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS) score. [ Time Frame: 1 week and 30 days post-dose for both administration sessions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Dawnita Reathaford
[email protected]
314-362-5939
Teddi Gray
[email protected]
314-747-1862

Find similar trials in St Louis, MO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Washington University School of Medicine· St Louis, MO

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