Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
NCT ID: NCT05711940
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
572 participants
INTERVENTIONAL
2023-02-14
2026-12-31
Brief Summary
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Detailed Description
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Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg.
The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week screening period.
Part A will include a nine-week follow-up from initial investigational product (IP) administration.
Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration.
Part C will include a further 26 weeks follow-up out to 52 weeks from initial IP administration.
In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
Psilocybin
COMP360 Psilocybin administered under supportive conditions
10 mg COMP360 Psilocybin
10 mg COMP360 Psilocybin
Psilocybin
COMP360 Psilocybin administered under supportive conditions
1 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin, active comparator
Psilocybin
COMP360 Psilocybin administered under supportive conditions
Interventions
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Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\])
3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening
4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ
6. At Screening, agreement to discontinue all prohibited medications
Exclusion Criteria
2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2)
5. Psychiatric inpatient within the past 12 months prior to Screening
6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
7. Transcranial magnetic stimulation within the past six months prior to Screening
8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening
9. Exposure to COMP360 psilocybin therapy prior to Screening
18 Years
ALL
No
Sponsors
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COMPASS Pathways
INDUSTRY
Responsible Party
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Locations
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Lighthouse Psychiatry Scottsdale
Gilbert, Arizona, United States
Clinical Innovations, Inc.
Bellflower, California, United States
M3 Wake Research
Encino, California, United States
The Regents of the University of California - San Diego
La Jolla, California, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
CalNeuro Research Group, Inc
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Piedmont Hospital Neuroscience Centre
Oakland, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
CITrials
Riverside, California, United States
Lumos Clinical Research Center
San Jose, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Stanford University
Stanford, California, United States
ASCLEPES Research Centers
Thousand Oaks, California, United States
Pacific Clinical Research Management Group, LLC
Upland, California, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Central Miami Medical Institute, LLC
Miami, Florida, United States
Behavioral Clinical Research, Inc.
Miami Lakes, Florida, United States
Health Synergy Clinical Research
Okeechobee, Florida, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
APG Research, LLC- Advanced Psychiatric Group
Orlando, Florida, United States
University South Florida
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Psychiatric Medicine Associates
Skokie, Illinois, United States
Harvard Medical School - McLean Hospital
Belmont, Massachusetts, United States
Adams Clinical - Boston (Copley Clinical)
Boston, Massachusetts, United States
University of Massachusetts Medical School
North Worcester, Massachusetts, United States
Adams Clinical - Boston
Watertown, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
University Of Michigan Comprehensive Depression Center
Ann Arbor, Michigan, United States
Institute for Integrative Therapies
Eden Prairie, Minnesota, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Alivation Research, LLC.
Lincoln, Nebraska, United States
Hassman Research Institute
Berlin, New Jersey, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
Fieve Clinical Research, Inc
New York, New York, United States
Spectrum Neuroscience and Treatment Institute
New York, New York, United States
Adams Clinical - New York
New York, New York, United States
New York State Psychiatric Institute
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Adams Clinical - New York
The Bronx, New York, United States
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
Cincinnati, Ohio, United States
Cleveland Clinic - Lutheran Hospital
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
The University of Texas at Austin - Dell Medical School
Austin, Texas, United States
Houston Clinical Trials, LLC
Bellaire, Texas, United States
Relaro Medical Trials
Dallas, Texas, United States
Center for Depression Research and Clinical Care
Dallas, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
Brain Health Consultants and TMS Center
Houston, Texas, United States
HCA Healthcare Research Institute - Medical City Green Oaks Hospital
Plano, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
The University of Utah - Huntsman Mental Health Institute
Salt Lake City, Utah, United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, United States
Diex Recherche Sherbrooke Inc.
Québec, B.C., Canada
Medical Arts Health Research Centre, Kamloops
Kamloops, British Columbia, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Medical Arts Research Group - Penticton
Penticton, British Columbia, Canada
Chatham-Kent Clnical Trials Centre
Chatham, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Centre for Neurology Studies
Vancouver, , Canada
Medical Arts Research Group
Vancouver, , Canada
National Institute of Mental Health
Klecany, , Czechia
Neuroterapie KH Sro
Kutná Hora, , Czechia
Psychiatric Ambulance
Ostrava, , Czechia
A-Shine s.r.o.
Pilsen, , Czechia
Psychedelicka klinika, s.r.o.
Prague, , Czechia
Institut Neuropsychiatricke Pece
Prague, , Czechia
Aalborg Universitetshospital-Psykiatrien Region Nordjylland
Aalborg, , Denmark
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nîmes, , France
Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593)
Paris, , France
Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)
Paris, , France
Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique
Paris, , France
Charite-Universitaetsmedizin Berlin
Berlin, , Germany
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie
Frankfurt, , Germany
ZiP Campus Luebeck
Lübeck, , Germany
Tallaght University Hospital
Dublin, , Ireland
La Nua Day Hospital Mental Health Centre
Galway, , Ireland
University Medical Center Groningen
Groningen, , Netherlands
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC)
Leiden, , Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, , Netherlands
Promente - Ośrodek Badań Klinicznych
Bydgoszcz, , Poland
Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych
Gdansk, , Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, , Poland
Hospital Clinic de Barcelona
Barcelona, , Spain
Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
FIDMAG Hermanas Hospitalarias
Sant Boi de Llobregat, , Spain
Hospital Universitario Río Hortega de Valladolid
Valladolid, , Spain
Hospital Provincial de Zamora - Servicio de Psiquiatria
Zamora, , Spain
Vuxenpsykiatrimottagningen
Landskrona, , Sweden
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
Lund, , Sweden
ClinSmart Sweden AB
Solna, , Sweden
Hälsoklustret
Stockholm, , Sweden
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall, United Kingdom
Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust
Chertsey, , United Kingdom
St. Pancras Clinical Research
Chester, , United Kingdom
Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust
Doncaster, , United Kingdom
Clinical Research Facility, Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust
Fulbourn, , United Kingdom
St. Pancras Clinical Research
London, , United Kingdom
King's College London - Institute of Psychiatry, Psychology
London, , United Kingdom
Clerkenwell Health
London, , United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre
Newcastle, , United Kingdom
University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health
Nottingham, , United Kingdom
The Warneford Hospital- NIHR Clinical Research Facility
Oxford, , United Kingdom
Sheffield Health and Social Care NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Other Identifiers
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COMP 006
Identifier Type: -
Identifier Source: org_study_id