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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

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 13, 2018
Results First Submitted Date  ICMJE February 7, 2023
Results First Posted Date  ICMJE April 24, 2023
Last Update Posted Date April 24, 2023
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2023)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)		 MADRS [ Time Frame: Up to 12 weeks ]
MADRS
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Official Title  ICMJE The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Brief Summary The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
Detailed Description The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE Drug: Psilocybin
Dose-finding
Study Arms  ICMJE
  • Experimental: Low dose
    Low dose Psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: Medium dose
    Medium dose Psilocybin
    Intervention: Drug: Psilocybin
  • Experimental: High dose
    High dose Psilocybin
    Intervention: Drug: Psilocybin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2022)		 233
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)		 216
Actual Study Completion Date  ICMJE September 27, 2021
Actual Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other comorbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Denmark,   Germany,   Ireland,   Netherlands,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03775200
Other Study ID Numbers  ICMJE COMP001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party COMPASS Pathways
Original Responsible Party Same as current
Current Study Sponsor  ICMJE COMPASS Pathways
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account COMPASS Pathways
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP