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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 : Completed
First Posted : December 13, 2018
Results First Posted : April 24, 2023
Last Update Posted : April 24, 2023
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)
Actual Enrollment : 233 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
Actual Primary Completion Date : July 30, 2021
Actual Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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 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
  Study Documents (Full-Text)

Documents provided by COMPASS Pathways:
Study Protocol  [PDF] July 22, 2019
Statistical Analysis Plan  [PDF] October 26, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.

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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
Results First Posted: April 24, 2023
Last Update Posted: April 24, 2023
Last Verified: April 2023

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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