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Not recruiting
Phase 3

COMP360

Sponsor:

COMPASS Pathways

Code:

NCT05711940

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Study Details

Brief summary:

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

Conditions

Treatment Resistant Depression

Study ID

NCT05711940

Start date

Feb 14, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Aged ≥18 years at Screening
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

Key Exclusion Criteria:

1. 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)
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

Study Design

Enrollment

568 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 25 mg COMP360 Psilocybin

25 mg COMP360 Psilocybin

experimental: 10 mg COMP360 Psilocybin

10 mg COMP360 Psilocybin

active comparator: 1 mg COMP360 Psilocybin

1 mg COMP360 Psilocybin, active comparator

Interventions

Psilocybin

COMP360 Psilocybin administered under supportive conditions

Primary outcome measure

  • COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score. [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Locations

Lighthouse Psychiatry Scottsdale

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Frank J Genova, MD

Clinical Innovations, Inc.

Recruiting

Bellflower, California, United States, 90706

Contacts

Principal Investigator:

Robert Bota, MD

M3 Wake Research

Recruiting

Encino, California, United States, 91316

Principal Investigator:

Clifford Feldman, MD

The Regents of the University of California - San Diego

Recruiting

La Jolla, California, United States, 92037-1337

Principal Investigator:

Cory Weissman, MD

Kadima Neuropsychiatry Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

David Feifel, MD

CalNeuro Research Group, Inc

Recruiting

Los Angeles, California, United States, 90025

Contacts

Principal Investigator:

Alexander Bystritsky, MD

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Principal Investigator:

Stephen Volk, MD

Piedmont Hospital Neuroscience Centre

Recruiting

Oakland, California, United States, 94610

Contacts

Principal Investigator:

Joshua Kuluva, MD

ATP Clinical Research, Inc.

Recruiting

Orange, California, United States, 92868

Contacts

ATP Clinical Research

949-354-5353

Sarah Perkins

sarahp@pnsoc.com

Principal Investigator:

Gustavo Alva, MD

Lumos Clinical Research Center

Recruiting

San Jose, California, United States, 95124

Contacts

Principal Investigator:

Sarbani Maitra, MD

Syrentis Clinical Research

Recruiting

Santa Ana, California, United States, 92705

Contacts

Principal Investigator:

John Duffy, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator:

Charles DeBattista, MD

ASCLEPES Research Centers

Recruiting

Thousand Oaks, California, United States, 93012

Contacts

Principal Investigator:

Arjun Reyes, MD

Pacific Clinical Research Management Group, LLC

Recruiting

Upland, California, United States, 91786

Contacts

Principal Investigator:

Rebecca Kornbluh, MD

Innovative Clinical Research, Inc.

Recruiting

Lauderhill, Florida, United States, 33319

Contacts

Principal Investigator:

Rishi Kakar, MD

Central Miami Medical Institute, LLC

Recruiting

Miami, Florida, United States, 33125

Principal Investigator:

Leonardo Alonso, MD

Health Synergy Clinical Research

Recruiting

Okeechobee, Florida, United States, 34972

Contacts

Principal Investigator:

Mohammad Nisar, MD

Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

Recruiting

Orlando, Florida, United States, 32801

Contacts

Principal Investigator:

Felipe Suplicy, MD

APG Research, LLC- Advanced Psychiatric Group

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Morteza Nadjafi, MD

University South Florida

Recruiting

Tampa, Florida, United States, 33613-4788

Contacts

Principal Investigator:

Ryan Wagoner, MD

Stedman Clinical Trials

Recruiting

Tampa, Florida, United States, 33613

Contacts

Principal Investigator:

Mary Stedman, MD

Health Synergy Clinical Research, LLC

Recruiting

West Palm Beach, Florida, United States, 33407

Principal Investigator:

Olugbenga Aje, MD

iResearch Atlanta

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Principal Investigator:

Saundra Maass-Robinson, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612-3227

Contacts

Principal Investigator:

John Zajecka, MD

Uptown Research Institute, LLC

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Principal Investigator:

John Sonnenberg, MD

Psychiatric Medicine Associates

Recruiting

Skokie, Illinois, United States, 60076

Principal Investigator:

Joshua Eloge, MD

Harvard Medical School - McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478-1064

Contacts

Principal Investigator:

Kerry Ressler, MD

Adams Clinical - Boston (Copley Clinical)

Recruiting

Boston, Massachusetts, United States, 02116

Contacts

Principal Investigator:

Dyanna Domilici, MD

University of Massachusetts Medical School

Recruiting

North Worcester, Massachusetts, United States, 01655

Contacts

Principal Investigator:

Anthony Rothschild, MD

Adams Clinical - Boston

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Principal Investigator:

Daniel Rutrick, MD

University Of Michigan Comprehensive Depression Center

Recruiting

Ann Arbor, Michigan, United States, 48109-2700

Contacts

Principal Investigator:

Sagar Parikh, MD

Institute for Integrative Therapies

Recruiting

Eden Prairie, Minnesota, United States, 55347

Contacts

Principal Investigator:

Ranji Varghese, MD

St. Charles Psychiatric Associates - Midwest Research Group

Recruiting

Saint Charles, Missouri, United States, 63304

Contacts

Principal Investigator:

Gregory Mattingly, MD

Alivation Research, LLC.

Recruiting

Lincoln, Nebraska, United States, 68526

Contacts

Principal Investigator:

Walter Duffy, MD

Hassman Research Institute

Recruiting

Berlin, New Jersey, United States, 08009

Contacts

HRI Recruitment Team

888-449-5080

Principal Investigator:

David Hassman, MD

Princeton Medical Institute

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Principal Investigator:

James Wolberg, MD

Bio Behavioral Health

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Principal Investigator:

Ashok K Patel, MD

Dent Neurosciences Research Center, Inc.

Recruiting

Amherst, New York, United States, 14226-1727

Principal Investigator:

Horacio Capote, MD

Fieve Clinical Research, Inc

Recruiting

New York, New York, United States, 10017

Contacts

Principal Investigator:

Paul Eder, MD

Spectrum Neuroscience and Treatment Institute

Recruiting

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

Contacts

Principal Investigator:

Eric Hollander, MD

Adams Clinical - New York

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Patricia Walsh, MD

New York State Psychiatric Institute

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

David Hellerstein, MD

Adams Clinical - New York

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Shama Farooq, MD

University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Fabiano Nery, MD

Cleveland Clinic - Lutheran Hospital

Recruiting

Cleveland, Ohio, United States, 44113-3108

Contacts

Principal Investigator:

Brian Barnett, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Subhdeep Virk, MD

Suburban Research Associates

Recruiting

Media, Pennsylvania, United States, 19063

Contacts

Suburban Research Associates

610-891-9024

Principal Investigator:

Shivkumar Hatti, MD

The University of Texas at Austin - Dell Medical School

Recruiting

Austin, Texas, United States, 78712

Contacts

Principal Investigator:

Julie Farrington, MD

Houston Clinical Trials, LLC

Recruiting

Bellaire, Texas, United States, 77401

Principal Investigator:

Alain Katic, MD

Relaro Medical Trials

Recruiting

Dallas, Texas, United States, 75243

Contacts

Principal Investigator:

Bradley Musser, MD

Center for Depression Research and Clinical Care

Recruiting

Dallas, Texas, United States, 75247-9119

Contacts

Principal Investigator:

Madhukar Trivedi, MD

North Texas Clinical Trials

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Diana Ghelber, MD

Brain Health Consultants and TMS Center

Recruiting

Houston, Texas, United States, 77046-2401

Principal Investigator:

Rayan Al Jurdi, MD

HCA Healthcare Research Institute - Medical City Green Oaks Hospital

Recruiting

Plano, Texas, United States, 75251

Contacts

Principal Investigator:

Ronnie Pollard, MD

Cedar Clinical Research

Recruiting

Draper, Utah, United States, 84020

Contacts

Principal Investigator:

Reid Robison, MD

Seattle Neuropsychiatric Treatment Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Rebecca Allen, MD

Diex Recherche Sherbrooke Inc.

Recruiting

Québec, B.C., Canada, J1L 0H8

Contacts

Principal Investigator:

Raymond Matte, MD

Medical Arts Health Research Centre, Kamloops

Recruiting

Kamloops, British Columbia, Canada

Contacts

Principal Investigator:

Tochukwu Dr., MD

Okanagan Clinical Trials

Recruiting

Kelowna, British Columbia, Canada, V1Y 1Z9

Contacts

Principal Investigator:

Eugene Okorie, MD

Medical Arts Research Group - Penticton

Recruiting

Penticton, British Columbia, Canada, V2A 5L5

Contacts

Principal Investigator:

Linda Grasswick, MD

Chatham-Kent Clnical Trials Centre

Recruiting

Chatham, Ontario, Canada

Contacts

Principal Investigator:

Ranjith Chandrasena, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Principal Investigator:

Sidney Kennedy, MD

Centre for Addiction and Mental Health (CAMH)

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Muhammad Husain, MD

Centre for Neurology Studies

Recruiting

Vancouver, Canada

Contacts

Principal Investigator:

Shimi Kang, MD

Medical Arts Research Group

Recruiting

Vancouver, Canada

Contacts

Principal Investigator:

Kevin Kjernisted, MD

More Information

Sponsor

COMPASS Pathways

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Keywords

  • psilocybin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by COMPASS Pathways on 2025-10-16.