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A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression

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.

Status
planned
Phase
Phase 2
Institution
Washington University School of Medicine
Start date
2026-06-01
End date
2031-12-01
Registry ID
NCT07582120

View trial record

Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.