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ACTIVE NOT RECRUITING
NCT05711940
PHASE3

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Sponsor: COMPASS Pathways

View on ClinicalTrials.gov

Summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Official title: A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

572

Start Date

2023-02-14

Completion Date

2026-12

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Psilocybin

COMP360 Psilocybin administered under supportive conditions

Locations (116)

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