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ACTIVE NOT RECRUITING

NCT05624268

PHASE3

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

Sponsor: COMPASS Pathways

View on ClinicalTrials.gov

Summary

Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2023-01-19

Completion Date

2026-04

Last Updated

2025-12-18

Healthy Volunteers

Conditions

Treatment Resistant Depression

Interventions

DRUG

Psilocybin

COMP360 Psilocybin administered under supportive conditions

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: Psychiatric 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

Locations (40)

University of Arizona College of Medicine - Tuscon

Tucson, Arizona, United States

ProScience Research Group

Culver City, California, United States

Collaborative Neuroscience Network, LLC

Garden Grove, California, United States

Kadima Neuropsychiatry Institute

La Jolla, California, United States

University California San Diego

La Jolla, California, United States

California Center for Psychedelic Therapy

Los Angeles, California, United States

CalNeuro Research Group, Inc

Los Angeles, California, United States

Clarity Clinical Research, LLC

Los Angeles, California, United States

ATP Clinical Research, Inc.

Orange, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Lumos Clinical Research Center

San Jose, California, United States

Stanford University

Stanford, California, United States

ASCLEPES Research Centers

Thousand Oaks, California, United States

Comprehensive Psychiatric Care

Norwich, Connecticut, United States

Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

Orlando, Florida, United States

APG Research, LLC

Orlando, Florida, United States

DMI Health Care Group, Inc

Tampa, Florida, United States

Meridien Research/Accel Research

Tampa, Florida, United States

Psych Atlanta

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Uptown Research Institute, LLC

Chicago, Illinois, United States

Sheppard Pratt Health System

Baltimore, Maryland, United States

CBH Health, LLC

Gaithersburg, Maryland, United States

Pharmasite Research, Inc

Pikesville, Maryland, United States

University of Massachusetts Medical School

North Worcester, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Midwest Research Group

Saint Charles, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Alivation Research, LLC.

Lincoln, Nebraska, United States

Bio Behavioral Health

Toms River, New Jersey, United States

New York State Psychiatric Institute

New York, New York, United States

The Medical Research Network, LLC

New York, New York, United States

Insight Clinical Trials, LLC

Beachwood, Ohio, United States

Neuro-Behaviroral Clinical Research, Inc.

North Canton, Ohio, United States

Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, United States

Global Medical Institutes, LLC, Scranton Medical Institute

Moosic, Pennsylvania, United States

UT Health Science Center at Houston (UTHSC-H)

Houston, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Core Clinical Research

Everett, Washington, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (40)