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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03775200
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : September 9, 2019
Information provided by (Responsible Party):
COMPASS Pathways

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

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Psilocybin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low dose
Low dose Psilocybin
Drug: Psilocybin

Experimental: Medium dose
Medium dose Psilocybin
Drug: Psilocybin

Experimental: High dose
High dose Psilocybin
Drug: Psilocybin

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Up to 12 weeks ]
    MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Upper age limit of 55 years is applicable only to USA sites

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03775200

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Contact: Susan Stansfield, PhD +44-7780-523013

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United States, California
Altman Clinical and Translational Research Institute, University of California Recruiting
San Diego, California, United States, 92093
Contact: Lea Jacinto   
Principal Investigator: Sidney Zisook         
United States, Louisiana
Ray Worthy Psychiatry LLC Recruiting
New Orleans, Louisiana, United States, 70123
Contact: Shari Taylor   
Principal Investigator: Ray Worthy         
United States, Maryland
Sheppard Pratt Health System Recruiting
Baltimore, Maryland, United States, 21204
Contact: Marylu Ortiz   
Principal Investigator: Scott Aaronson         
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Peter Arden   
Principal Investigator: David Hellerstein         
United States, Texas
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77054
Contact: Valeria Cuellar   
Principal Investigator: Jair Soares         
Canada, Ontario
Canadian Rapid Treatment Centre of Excellence Recruiting
Mississauga, Ontario, Canada
Contact: Nelson Rodrigues   
Principal Investigator: Roger McIntyre         
Tallaght University Hospital Recruiting
Dublin, Ireland
Contact: Annie Baker   
Principal Investigator: Veronica O'Keane         
Groningen University Medical Centre Recruiting
Groningen, Netherlands
Contact: Maartje Hofman   
Principal Investigator: Robert Schoevers         
Leiden University Medical Centre Recruiting
Leiden, Netherlands
Contact: Florence van der Does   
Principal Investigator: Nic van der Wee         
Utrecht University Medical Centre Recruiting
Utrecht, Netherlands
Contact: Paula Ywema   
Principal Investigator: Metten Somers         
Hospital de Dia Numancia Recruiting
Barcelona, Spain
Contact: Sandra Borras   
Principal Investigator: Oscar Alvarez Bobo         
Institute Hospital del Mar of Medical Research (IMIM) Recruiting
Barcelona, Spain
Contact: Matilde Elices   
United Kingdom
Wolfson Research Centre, Campus for Ageing and Vitality Recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 5PL
Contact: Wendy Hall    +44(0)191 208 1362   
Principal Investigator: Hamish McAllister-Williams         
Kings College London, Institute of Psychiatry, Psychology and Neurology Recruiting
London, United Kingdom
Contact: Catherine Bird   
Principal Investigator: Allan Young         
Greater Manchester Mental Health Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Carmel Thomas    +44-7920-726555   
Principal Investigator: Peter Talbot         
Sponsors and Collaborators
COMPASS Pathways

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Responsible Party: COMPASS Pathways Identifier: NCT03775200     History of Changes
Other Study ID Numbers: COMP001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs