WithdrawnPhase 2psilocybin
Psilocybin for Major Depressive Disorder
Sponsored by Washington University School of Medicine
NCT ID
NCT05675800
Start Date
2024-01-01
Est. Completion
2025-03-31
About This Study
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.
Conditions Studied
Interventions
- •Psilocybin
Eligibility
Age:18 Years - 85 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity * Aged 18-85 * Ability and willingness to attend study visits and complete study assessments Exclusion Criteria: * Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT \> 150, QTc \> 450ms, MELD \> 9) * Depression deemed secondary to a severe medical condition * Recent use of any classical psychedelic drug or MDMA * Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS) * Intention to begin any new treatment for depression prior to primary outcome determination * Use of any excluded medication * Active substance use disorder * Presence of any psychiatric condition that may interfere with the safe administration of psilocybin * Active suicidal ideation