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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

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