Psilocybin-Assisted Therapy as a Treatment for Depression
NCT07582120 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-20
Summary
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.
Conditions
Interventions
- DRUG
-
Psilocybin (Usona Institute)
Capsule containing 25 mg of synthetic psilocybin
Sponsors & Collaborators
-
Washington University School of Medicine
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2031-06-30
- Completion
- 2031-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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