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

NCT05624268 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: COMP 005
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 40

Brief Summary

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

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• COMP360 25 mg versus placebo 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 (1)

• COMP360 25 mg versus placebo for the change from baseline in SDS total score

  Week 6

Study Arms (2)

25 mg COMP360 Psilocybin

EXPERIMENTAL

25 mg COMP360 Psilocybin

Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Psilocybin

Interventions

Psilocybin DRUG

COMP360 Psilocybin administered under supportive conditions

Also known as: COMP360

25 mg COMP360 Psilocybin; Placebo

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 (40)

University of Arizona College of Medicine - Tuscon

Tucson, Arizona, 85724, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

University California San Diego

La Jolla, California, 92037, United States

Location

California Center for Psychedelic Therapy

Los Angeles, California, 90004, United States

Location

CalNeuro Research Group, Inc

Los Angeles, California, 90025, United States

Location

Clarity Clinical Research, LLC

Los Angeles, California, 90064, United States

Location

ATP Clinical Research, Inc.

Orange, California, 92868, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Lumos Clinical Research Center

San Jose, California, 95124, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

ASCLEPES Research Centers

Thousand Oaks, California, 93012, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

DMI Health Care Group, Inc

Tampa, Florida, 33782, United States

Location

Meridien Research/Accel Research

Tampa, Florida, 33803, United States

Location

Psych Atlanta

Atlanta, Georgia, 30060, United States

Location

Emory University

Atlanta, Georgia, 30329-2209, United States

Location

Uptown Research Institute, LLC

Chicago, Illinois, 60640, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21044, United States

Location

CBH Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Pharmasite Research, Inc

Pikesville, Maryland, 21208, United States

Location

University of Massachusetts Medical School

North Worcester, Massachusetts, 01655, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55416, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Alivation Research, LLC.

Lincoln, Nebraska, 68526, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Insight Clinical Trials, LLC

Beachwood, Ohio, 44122, United States

Location

Neuro-Behaviroral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Global Medical Institutes, LLC, Scranton Medical Institute

Moosic, Pennsylvania, 18507, United States

Location

UT Health Science Center at Houston (UTHSC-H)

Houston, Texas, 77030, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

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: November 14, 2022
• First Posted: November 22, 2022
• Study Start: January 19, 2023
• Primary Completion: May 28, 2025
• Study Completion: April 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (40)