The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (P-TRD)

April 21, 2023 updated by: COMPASS Pathways
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada
        • Canadian Rapid Treatment Centre of Excellence
      • Toronto, Ontario, Canada
        • Centre for Addiction and Mental Health
  • Czechia
      • Klecany, Czechia
        • National Institute of Mental Health Czech Republic
  • Denmark
      • Aalborg, Denmark
        • Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
  • Germany
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
  • Ireland
      • Dublin, Ireland
        • Tallaght University Hospital
  • Netherlands
      • Groningen, Netherlands
        • Groningen University Medical Centre
      • Leiden, Netherlands
        • Leiden University Medical Centre
      • Utrecht, Netherlands
        • Utrecht University Medical Centre
  • Portugal
      • Lisboa, Portugal
        • Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
  • Spain
      • Barcelona, Spain
        • Hospital de Dia Numancia
      • Barcelona, Spain
        • Institute Hospital del Mar of Medical Research (IMIM)
  • United Kingdom
      • London, United Kingdom, EC2Y 8EA
        • St. Pancras Clinical Research
      • London, United Kingdom
        • Kings College London, Institute of Psychiatry, Psychology and Neurology
      • Manchester, United Kingdom
        • Greater Manchester Mental Health Foundation Trust
    • Avon
      • Bristol, Avon, United Kingdom
        • Clinical Research and Imaging Centre
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 5PL
        • Wolfson Research Centre, Campus for Ageing and Vitality
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Kadima Neuropsychiatry Institute
      • San Diego, California, United States, 92093
        • Altman Clinical and Translational Research Institute, University of California
      • Stanford, California, United States, 94305
        • Stanford Department of Psychiatry
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Mood and Anxiety Disorders Program Emory University School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70123
        • Ray Worthy Psychiatry LLC
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Sheppard Pratt Health System
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
    • Texas
      • Houston, Texas, United States, 77054
        • UT Center of Excellence on Mood Disorders, University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
Low dose Psilocybin
Drug: Psilocybin
Dose-finding
Experimental: Medium dose
Medium dose Psilocybin
Drug: Psilocybin
Dose-finding
Experimental: High dose
High dose Psilocybin
Drug: Psilocybin
Dose-finding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
Time Frame: Change from Baseline to Week 3
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.
Change from Baseline to Week 3
MADRS Change From Baseline to Week 3, Sensitivity Analysis
Time Frame: Change from Baseline to Week 3
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.
Change from Baseline to Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COMPASS Pathways

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMP001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment Resistant Depression

Clinical Trials on Psilocybin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe