P-TRD: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Sponsor
COMPASS Pathways (Industry)
Overall Status
Completed
CT.gov ID
NCT03775200
Collaborator
(none)
233
25
3
30.9
9.3
0.3
Study Details
Study Description
Brief Summary
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Study Design
Study Type:
Interventional
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
:
Mar 1, 2019
Actual Primary Completion Date
:
Jul 30, 2021
Actual Study Completion Date
:
Sep 27, 2021
Arms and Interventions
| 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
Primary Outcome Measures
- Montgomery Asberg Depression Rating Scale (MADRS) [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
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of TRD
Exclusion Criteria:
- Other comorbidities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kadima Neuropsychiatry Institute | La Jolla | California | United States | 92037 |
| 2 | Altman Clinical and Translational Research Institute, University of California | San Diego | California | United States | 92093 |
| 3 | Stanford Department of Psychiatry | Stanford | California | United States | 94305 |
| 4 | Mood and Anxiety Disorders Program Emory University School of Medicine | Atlanta | Georgia | United States | 30329 |
| 5 | Ray Worthy Psychiatry LLC | New Orleans | Louisiana | United States | 70123 |
| 6 | Sheppard Pratt Health System | Baltimore | Maryland | United States | 21204 |
| 7 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
| 8 | UT Center of Excellence on Mood Disorders, University of Texas Health Science Center | Houston | Texas | United States | 77054 |
| 9 | Canadian Rapid Treatment Centre of Excellence | Mississauga | Ontario | Canada | |
| 10 | Centre for Addiction and Mental Health | Toronto | Ontario | Canada | |
| 11 | National Institute of Mental Health Czech Republic | Klecany | Czechia | ||
| 12 | Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg | Aalborg | Denmark | ||
| 13 | Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin | Berlin | Germany | 12203 | |
| 14 | Tallaght University Hospital | Dublin | Ireland | ||
| 15 | Groningen University Medical Centre | Groningen | Netherlands | ||
| 16 | Leiden University Medical Centre | Leiden | Netherlands | ||
| 17 | Utrecht University Medical Centre | Utrecht | Netherlands | ||
| 18 | Unidade de Neuropsiquiatria, Centro Clinico Champalimaud | Lisboa | Portugal | ||
| 19 | Hospital de Dia Numancia | Barcelona | Spain | ||
| 20 | Institute Hospital del Mar of Medical Research (IMIM) | Barcelona | Spain | ||
| 21 | Clinical Research and Imaging Centre | Bristol | Avon | United Kingdom | |
| 22 | Wolfson Research Centre, Campus for Ageing and Vitality | Newcastle Upon Tyne | Tyne And Wear | United Kingdom | NE4 5PL |
| 23 | St. Pancras Clinical Research | London | United Kingdom | EC2Y 8EA | |
| 24 | Kings College London, Institute of Psychiatry, Psychology and Neurology | London | United Kingdom | ||
| 25 | Greater Manchester Mental Health Foundation Trust | Manchester | United Kingdom |
Sponsors and Collaborators
- COMPASS Pathways
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
COMPASS Pathways
ClinicalTrials.gov Identifier:
NCT03775200
Other Study ID Numbers:
- COMP001
First Posted:
Dec 13, 2018
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: