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Psilocybin for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Psilocybin Active Dose Treatment A

    Psilocybin Active Dose Treatment B

    Arm Description

    Psilocybin

    Psilocybin

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
    Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

    Full Information

    First Posted
    November 22, 2022
    Last Updated
    April 24, 2023
    Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05675800
    Brief Title
    Psilocybin for Major Depressive Disorder
    Official Title
    Psilocybin for the Treatment of Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Psilocybin Active Dose Treatment A
    Arm Type
    Experimental
    Arm Description
    Psilocybin
    Arm Title
    Psilocybin Active Dose Treatment B
    Arm Type
    Experimental
    Arm Description
    Psilocybin
    Intervention Type
    Drug
    Intervention Name(s)
    Psilocybin
    Intervention Description
    Psilocybin administered with psychological support
    Primary Outcome Measure Information:
    Title
    MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
    Description
    Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
    Time Frame
    3 weeks post-treatment
    Title
    Adverse Events
    Description
    Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
    Time Frame
    Up to 12 weeks post-treatment
    Title
    Study Retention and Completion
    Description
    Rates of successful attendance of study visits and completion of study
    Time Frame
    Throughout study participation (12-17 weeks)
    Secondary Outcome Measure Information:
    Title
    MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
    Description
    Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
    Time Frame
    12 weeks post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Demetrius Perry
    Phone
    314-747-5514
    Email
    perry.demetrius@wustl.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Teddi Gray
    Phone
    314-747-1862
    Email
    grayt@wustl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ginger Nicol, MD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study protocol and analysis plan will be publicly available on publication of the research. Individual researchers can request individual participant data collected during the trial, after deidentification, for specifically outlined research-related purposes upon publication.
    IPD Sharing Time Frame
    Upon publication, indefinitely
    IPD Sharing Access Criteria
    Investigators with a research plan that is reviewed and approved by the P.I.

    Learn more about this trial

    Psilocybin for Major Depressive Disorder

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