Psilocybin for Major Depressive Disorder

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Psilocybin

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