The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Psilocybin

Brief Summary

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Intervention / Treatment

  • Psilocybin (DRUG)
    Dose-finding

Condition or Disease

  • Treatment Resistant Depression

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 233 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Mar 01, 2019 ACTUAL
    Primary Completion: Jul 30, 2021 ACTUAL
    Completion Date: Sep 27, 2021 ACTUAL
    Study First Posted: Dec 13, 2018 ACTUAL
    Results First Posted: Apr 24, 2023 ACTUAL
    Last Updated: Apr 21, 2023

    Sponsors / Collaborators

    Lead Sponsor: COMPASS Pathways
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA
    Toronto, Ontario, Canada
    Baltimore, Maryland, USA
    London, England, United Kingdom
    Dublin, Ireland
    Atlanta, Georgia, USA
    Berlin, Germany
    Houston, Texas, USA
    Topolová, Klecany, Czechia
    San Diego, California, USA
    Lisbon, Portugal
    La Jolla, California, USA
    Stanford, California, USA
    New Orleans, Louisiana, USA
    Mississauga, Ontario, Canada
    Klecany, Czechia
    Aalborg, Denmark
    Groningen, Netherlands
    Leiden, South Holland, Netherlands
    Utrecht, Netherlands
    Barcelona, Spain
    Manchester, England, United Kingdom
    Newcastle upon Tyne, England, United Kingdom
    Bristol, England, United Kingdom
    Avon, United Kingdom

    The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

    Participant Groups

    • Low dose Psilocybin

    • Medium dose Psilocybin

    • High dose Psilocybin

    Eligibility Criteria

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

    Inclusion Criteria:

    * Diagnosis of TRD

    Exclusion Criteria:

    * Other comorbidities

    Primary Outcomes

    • MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.

    • MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.

    More Details

    NCT Number: NCT03775200
    Acronym: P-TRD
    Other IDs: COMP001
    Study URL: https://clinicaltrials.gov/study/NCT03775200
    Last updated: Sep 29, 2023