Psilocybin for Major Depressive Disorder

Phase 2

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: Psilocybin

• Registration Number: NCT05675800
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Study Start: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psilocybin Active Dose Treatment A	Psilocybin	Psilocybin
Psilocybin Active Dose Treatment B	Psilocybin	Psilocybin

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 12 weeks post-treatment	Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Study Retention and Completion	Throughout study participation (12-17 weeks)	Rates of successful attendance of study visits and completion of study
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline	3 weeks post-treatment	Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

Secondary Outcome Measures

Name	Time	Method
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline	12 weeks post-treatment	Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms