drugset / Trial / NCT07582120

Psilocybin-Assisted Therapy as a Treatment for Depression

NCT07582120

Phase 2 Not yet recruiting 50 enrolled Washington University School of Medicine
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2026-06
Primary completion
2031-06
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg

Indications