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NCT03775200 Clinical Trial

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

Treatment Resistant Depression Clinical Trial

— P-TRD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03775200
Other study ID # COMP001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2019
Est. completion date September 27, 2021

Study information
Verified date April 2023
Source COMPASS Pathways
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 233
Est. completion date September 27, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of TRD Exclusion Criteria: - Other comorbidities

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Psilocybin
Dose-finding

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

Sponsors (1)
Lead Sponsor Collaborator
COMPASS Pathways

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Germany,  Ireland,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Montgomery Asberg Depression Rating Scale (MADRS) 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
Primary MADRS Change From Baseline to Week 3, Sensitivity Analysis 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
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