The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
- Registration Number
- NCT03775200
- Lead Sponsor
- COMPASS Pathways
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
- Diagnosis of TRD
- Other comorbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose Psilocybin High dose Psilocybin Low dose Psilocybin Low dose Psilocybin Medium dose Psilocybin Medium dose Psilocybin
- Primary Outcome Measures
Name Time Method MADRS Change From Baseline to Week 3, Sensitivity Analysis 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.
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Kadima Neuropsychiatry Institute
🇺🇸La Jolla, California, United States
Altman Clinical and Translational Research Institute, University of California
🇺🇸San Diego, California, United States
Stanford Department of Psychiatry
🇺🇸Stanford, California, United States
Mood and Anxiety Disorders Program Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Ray Worthy Psychiatry LLC
🇺🇸New Orleans, Louisiana, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
🇺🇸Houston, Texas, United States
Canadian Rapid Treatment Centre of Excellence
🇨🇦Mississauga, Ontario, Canada
National Institute of Mental Health Czech Republic
🇨🇿Klecany, Czechia
Centre for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada
Groningen University Medical Centre
🇳🇱Groningen, Netherlands
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Tallaght University Hospital
🇮🇪Dublin, Ireland
Leiden University Medical Centre
🇳🇱Leiden, Netherlands
Unidade de Neuropsiquiatria, Centro Clinico Champalimaud
🇵🇹Lisboa, Portugal
Utrecht University Medical Centre
🇳🇱Utrecht, Netherlands
Clinical Research and Imaging Centre
🇬🇧Bristol, Avon, United Kingdom
Institute Hospital del Mar of Medical Research (IMIM)
🇪🇸Barcelona, Spain
Hospital de Dia Numancia
🇪🇸Barcelona, Spain
Wolfson Research Centre, Campus for Ageing and Vitality
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Greater Manchester Mental Health Foundation Trust
🇬🇧Manchester, United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology
🇬🇧London, United Kingdom
Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg
🇩🇰Aalborg, Denmark
St. Pancras Clinical Research
🇬🇧London, United Kingdom