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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775200
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

Study Description
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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
Study Design
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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 : March 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose
Low dose Psilocybin
 Drug: Psilocybin
Dose-ranging
Experimental: Medium dose
Medium dose Psilocybin
 Drug: Psilocybin
Dose-ranging
Experimental: High dose
High dose Psilocybin
 Drug: Psilocybin
Dose-ranging


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other comorbidities
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03775200


Locations
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Sponsors and Collaborators
COMPASS Pathways
More Information
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Responsible Party: COMPASS Pathways
ClinicalTrials.gov Identifier: NCT03775200    
Other Study ID Numbers: COMP001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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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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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs