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

Primary Purpose

Treatment Resistant Depression

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
COMPASS Pathways
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of TRD

Exclusion Criteria:

  • Other comorbidities

Sites / Locations

  • Kadima Neuropsychiatry Institute
  • Altman Clinical and Translational Research Institute, University of California
  • Stanford Department of Psychiatry
  • Mood and Anxiety Disorders Program Emory University School of Medicine
  • Ray Worthy Psychiatry LLC
  • Sheppard Pratt Health System
  • New York State Psychiatric Institute
  • UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
  • Canadian Rapid Treatment Centre of Excellence
  • Centre for Addiction and Mental Health
  • National Institute of Mental Health Czech Republic
  • Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
  • Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
  • Tallaght University Hospital
  • Groningen University Medical Centre
  • Leiden University Medical Centre
  • Utrecht University Medical Centre
  • Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
  • Hospital de Dia Numancia
  • Institute Hospital del Mar of Medical Research (IMIM)
  • Clinical Research and Imaging Centre
  • Wolfson Research Centre, Campus for Ageing and Vitality
  • St. Pancras Clinical Research
  • Kings College London, Institute of Psychiatry, Psychology and Neurology
  • Greater Manchester Mental Health Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose

Medium dose

High dose

Arm Description

Low dose Psilocybin

Medium dose Psilocybin

High dose Psilocybin

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
April 21, 2023
Sponsor
COMPASS Pathways
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1. Study Identification

Unique Protocol Identification Number
NCT03775200
Brief Title
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Acronym
P-TRD
Official Title
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
COMPASS Pathways

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
Low dose Psilocybin
Arm Title
Medium dose
Arm Type
Experimental
Arm Description
Medium dose Psilocybin
Arm Title
High dose
Arm Type
Experimental
Arm Description
High dose Psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Dose-finding
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
Description
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.
Time Frame
Change from Baseline to Week 3
Title
MADRS Change From Baseline to Week 3, Sensitivity Analysis
Description
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.
Time Frame
Change from Baseline to Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of TRD Exclusion Criteria: Other comorbidities
Facility Information:
Facility Name
Kadima Neuropsychiatry Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Altman Clinical and Translational Research Institute, University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Department of Psychiatry
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Mood and Anxiety Disorders Program Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Ray Worthy Psychiatry LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70123
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Canadian Rapid Treatment Centre of Excellence
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
National Institute of Mental Health Czech Republic
City
Klecany
Country
Czechia
Facility Name
Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
City
Aalborg
Country
Denmark
Facility Name
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Tallaght University Hospital
City
Dublin
Country
Ireland
Facility Name
Groningen University Medical Centre
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Centre
City
Leiden
Country
Netherlands
Facility Name
Utrecht University Medical Centre
City
Utrecht
Country
Netherlands
Facility Name
Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
City
Lisboa
Country
Portugal
Facility Name
Hospital de Dia Numancia
City
Barcelona
Country
Spain
Facility Name
Institute Hospital del Mar of Medical Research (IMIM)
City
Barcelona
Country
Spain
Facility Name
Clinical Research and Imaging Centre
City
Bristol
State/Province
Avon
Country
United Kingdom
Facility Name
Wolfson Research Centre, Campus for Ageing and Vitality
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
St. Pancras Clinical Research
City
London
ZIP/Postal Code
EC2Y 8EA
Country
United Kingdom
Facility Name
Kings College London, Institute of Psychiatry, Psychology and Neurology
City
London
Country
United Kingdom
Facility Name
Greater Manchester Mental Health Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36322843
Citation
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.
Results Reference
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The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

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