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

NCT05711940 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: COMP 006
• Study Type: interventional
• Target: 572
• Locations: 12 countries
• Sites: 116

Brief Summary

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

Conditions

Treatment Resistant Depression

Keywords

psilocybin

Outcome Measures

Primary Outcomes (1)

• COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.

  Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity

  Week 6

Secondary Outcomes (3)

• COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.

  Week 6

• COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.

  Week 6

• COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.

  Week 6

Study Arms (3)

25 mg COMP360 Psilocybin

EXPERIMENTAL

25 mg COMP360 Psilocybin

Drug: Psilocybin

10 mg COMP360 Psilocybin

EXPERIMENTAL

10 mg COMP360 Psilocybin

Drug: Psilocybin

1 mg COMP360 Psilocybin

ACTIVE COMPARATOR

1 mg COMP360 Psilocybin, active comparator

Drug: Psilocybin

Interventions

Psilocybin DRUG

COMP360 Psilocybin administered under supportive conditions

Also known as: COMP360

1 mg COMP360 Psilocybin; 10 mg COMP360 Psilocybin; 25 mg COMP360 Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years at Screening
• Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\])
• 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
• MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
• 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
• At Screening, agreement to discontinue all prohibited medications

You may not qualify if:

• Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)
• Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
• Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
• 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)
• Psychiatric inpatient within the past 12 months prior to Screening
• Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
• Transcranial magnetic stimulation within the past six months prior to Screening
• 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
• Exposure to COMP360 psilocybin therapy prior to Screening

Sponsors & Collaborators

• COMPASS Pathways: lead

Study Sites (116)

Lighthouse Psychiatry Scottsdale

Gilbert, Arizona, 85234, United States

Location

Clinical Innovations, Inc.

Bellflower, California, 90706, United States

Location

M3 Wake Research

Encino, California, 91316, United States

Location

The Regents of the University of California - San Diego

La Jolla, California, 92037-1337, United States

Location

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

CalNeuro Research Group, Inc

Los Angeles, California, 90025, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Piedmont Hospital Neuroscience Centre

Oakland, California, 94610, United States

Location

ATP Clinical Research, Inc.

Orange, California, 92868, United States

Location

CITrials

Riverside, California, 92506, United States

Location

Lumos Clinical Research Center

San Jose, California, 95124, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

ASCLEPES Research Centers

Thousand Oaks, California, 93012, United States

Location

Pacific Clinical Research Management Group, LLC

Upland, California, 91786, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Central Miami Medical Institute, LLC

Miami, Florida, 33125, United States

Location

Behavioral Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

Location

Health Synergy Clinical Research

Okeechobee, Florida, 34972, United States

Location

Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

APG Research, LLC- Advanced Psychiatric Group

Orlando, Florida, 32803, United States

Location

University South Florida

Tampa, Florida, 33613-4788, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3227, United States

Location

Uptown Research Institute, LLC

Chicago, Illinois, 60640, United States

Location

Psychiatric Medicine Associates

Skokie, Illinois, 60076, United States

Location

Harvard Medical School - McLean Hospital

Belmont, Massachusetts, 02478-1064, United States

Location

Adams Clinical - Boston (Copley Clinical)

Boston, Massachusetts, 02116, United States

Location

University of Massachusetts Medical School

North Worcester, Massachusetts, 01655, United States

Location

Adams Clinical - Boston

Watertown, Massachusetts, 02472, United States

Location

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States

Location

University Of Michigan Comprehensive Depression Center

Ann Arbor, Michigan, 48109-2700, United States

Location

Institute for Integrative Therapies

Eden Prairie, Minnesota, 55347, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC.

Lincoln, Nebraska, 68526, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226-1727, United States

Location

Fieve Clinical Research, Inc

New York, New York, 10017, United States

Location

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021-4157, United States

Location

Adams Clinical - New York

New York, New York, 10029, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Adams Clinical - New York

The Bronx, New York, 10461, United States

Location

University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic - Lutheran Hospital

Cleveland, Ohio, 44113-3108, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

The University of Texas at Austin - Dell Medical School

Austin, Texas, 78712, United States

Location

Houston Clinical Trials, LLC

Bellaire, Texas, 77401, United States

Location

Relaro Medical Trials

Dallas, Texas, 75243, United States

Location

Center for Depression Research and Clinical Care

Dallas, Texas, 75247-9119, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

Brain Health Consultants and TMS Center

Houston, Texas, 77046-2401, United States

Location

HCA Healthcare Research Institute - Medical City Green Oaks Hospital

Plano, Texas, 75251, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

The University of Utah - Huntsman Mental Health Institute

Salt Lake City, Utah, 84108, United States

Location

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, 98104, United States

Location

Diex Recherche Sherbrooke Inc.

Québec, B.C., J1L 0H8, Canada

Location

Medical Arts Health Research Centre, Kamloops

Kamloops, British Columbia, Canada

Location

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Medical Arts Research Group - Penticton

Penticton, British Columbia, V2A 5L5, Canada

Location

Chatham-Kent Clnical Trials Centre

Chatham, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

Centre for Neurology Studies

Vancouver, Canada

Location

Medical Arts Research Group

Vancouver, Canada

Location

National Institute of Mental Health

Klecany, 25067, Czechia

Location

Neuroterapie KH Sro

Kutná Hora, 28401, Czechia

Location

Psychiatric Ambulance

Ostrava, 70868, Czechia

Location

A-Shine s.r.o.

Pilsen, 30100, Czechia

Location

Psychedelicka klinika, s.r.o.

Prague, 16300, Czechia

Location

Institut Neuropsychiatricke Pece

Prague, 18600, Czechia

Location

Aalborg Universitetshospital-Psykiatrien Region Nordjylland

Aalborg, 9000, Denmark

Location

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Nîmes, 30000, France

Location

Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593)

Paris, 75013, France

Location

Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)

Paris, 75014, France

Location

Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique

Paris, 75014, France

Location

Charite-Universitaetsmedizin Berlin

Berlin, 12203, Germany

Location

Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie

Frankfurt, 60528, Germany

Location

ZiP Campus Luebeck

Lübeck, 23562, Germany

Location

Tallaght University Hospital

Dublin, D24 NR0A, Ireland

Location

La Nua Day Hospital Mental Health Centre

Galway, H91 VE03, Ireland

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC)

Leiden, 2300, Netherlands

Location

Universitair Medisch Centrum Utrecht (UMC Utrecht)

Utrecht, 3584 CG, Netherlands

Location

Promente - Ośrodek Badań Klinicznych

Bydgoszcz, 85-133, Poland

Location

Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych

Gdansk, 80-214, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)

Barcelona, 08830, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

FIDMAG Hermanas Hospitalarias

Sant Boi de Llobregat, 08830, Spain

Location

Hospital Universitario Río Hortega de Valladolid

Valladolid, 47012, Spain

Location

Hospital Provincial de Zamora - Servicio de Psiquiatria

Zamora, 49021, Spain

Location

Vuxenpsykiatrimottagningen

Landskrona, 26153, Sweden

Location

Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)

Lund, 22185, Sweden

Location

ClinSmart Sweden AB

Solna, 17164, Sweden

Location

Hälsoklustret

Stockholm, 11239, Sweden

Location

Cornwall Partnership NHS Foundation Trust

Bodmin, Cornwall, PL31 2QT, United Kingdom

Location

Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust

Chertsey, KT16 9AU, United Kingdom

Location

St. Pancras Clinical Research

Chester, CH2 1HX, United Kingdom

Location

Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust

Doncaster, DN4 8QN, United Kingdom

Location

Clinical Research Facility, Royal Devon and Exeter Hospital

Exeter, EX2 5DW, United Kingdom

Location

Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust

Fulbourn, CB21 5EF, United Kingdom

Location

St. Pancras Clinical Research

London, EC2Y 8EA, United Kingdom

Location

King's College London - Institute of Psychiatry, Psychology

London, SE5 8AF, United Kingdom

Location

Clerkenwell Health

London, W1G 8DR, United Kingdom

Location

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre

Newcastle, NE4 5PL, United Kingdom

Location

University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health

Nottingham, NG7 2TU, United Kingdom

Location

The Warneford Hospital- NIHR Clinical Research Facility

Oxford, OX3 7JX, United Kingdom

Location

Sheffield Health and Social Care NHS Foundation Trust

Sheffield, S10 3TH, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: February 14, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

IE (2); CA (9); FR (4); DE (3); CZ (6); ES (6); US (62); SE (4); DK (1); GB (13); NL (3); PL (3)