Psilocybin for Major Depressive Disorder

Psilocybin

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.

Intervention / Treatment

  • Psilocybin (DRUG)
    Psilocybin administered with psychological support

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 18 Years to 85 Years
    Enrollment: 35 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 01, 2024 ESTIMATED
    Primary Completion: Jan 01, 2025 ESTIMATED
    Completion Date: Mar 31, 2025 ESTIMATED
    Study First Posted: Jan 09, 2023 ACTUAL
    Last Updated: Apr 24, 2023

    Sponsors / Collaborators

    Lead Sponsor: Washington University School of Medicine
    Responsible Party: N/A

    Participant Groups

    • Psilocybin

    • Psilocybin

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 85
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

    • Rates of adverse events related to treatment, as determined by multiple data collection mechanisms

    • Rates of successful attendance of study visits and completion of study

    Secondary Outcomes

    • Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

    More Details

    NCT Number: NCT05675800
    Other IDs: 202209153
    Study URL: https://clinicaltrials.gov/study/NCT05675800
    Last updated: Sep 29, 2023