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WithdrawnPhase 2

Psilocybin for Major Depressive Disorder

NCT05675800 · Washington University School of Medicine

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
Study sites

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline

    Measured over 3 weeks post-treatment

  • Adverse Events

    Measured over Up to 12 weeks post-treatment

  • Study Retention and Completion

    Measured over Throughout study participation (12-17 weeks)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 85 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05675800 on ClinicalTrials.gov →

Last updated in the registry 2024-07-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits