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

Last updated: March 27, 2025
Sponsor: COMPASS Pathways
Overall Status: Active - Recruiting

Phase

3

Condition

Depression

Treatment

Psilocybin

Clinical Study ID

NCT05711940
COMP 006
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Aged ≥18 years at Screening

  2. Major depression without psychotic features (single or recurrent episode as informedby 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 episodeof depression, the length of the current episode must be ≥3 months and ≤2 years atScreening

  4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severityof 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 determinedthrough the Massachusetts General Hospital Antidepressant Treatment ResponseQuestionnaire (MGH-ATRQ) and using the supplementary advice on additionalantidepressants not included in MGH-ATRQ

  6. At Screening, agreement to discontinue all prohibited medications

Exclusion

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 personalitydisorder as assessed by a structured clinical interview (MINI 7.0.2)

  2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personalitydisorder, or any ongoing serious psychiatric comorbidity based on medical historyand clinical judgement

  3. Borderline personality disorder as demonstrated by medical history or the MiniInternational Neuropsychiatric Interview Plus (MINI plus) - borderline personalitydisorder module

  4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexianervosa 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 stimulationduring 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 stablefor the duration of the study. Psychological therapies cannot have been initiatedwithin 30 days prior to Screening

  9. Exposure to COMP360 psilocybin therapy prior to Screening

Study Design

Total Participants: 568
Treatment Group(s): 1
Primary Treatment: Psilocybin
Phase: 3
Study Start date:
February 14, 2023
Estimated Completion Date:
May 31, 2025

Study Description

This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD.

Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg.

The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration.

In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.

Connect with a study center

  • Diex Recherche Sherbrooke Inc.

    Québec, B.C. J1L 0H8
    Canada

    Active - Recruiting

  • Medical Arts Health Research Centre, Kamloops

    Kamloops, British Columbia
    Canada

    Active - Recruiting

  • Okanagan Clinical Trials

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Active - Recruiting

  • Medical Arts Research Group - Penticton

    Penticton, British Columbia V2A 5L5
    Canada

    Active - Recruiting

  • Chatham-Kent Clnical Trials Centre

    Chatham, Ontario
    Canada

    Active - Recruiting

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • St. Michaels Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Centre for Neurology Studies

    Vancouver,
    Canada

    Active - Recruiting

  • Medical Arts Research Group

    Vancouver,
    Canada

    Active - Recruiting

  • National Institute of Mental Health

    Klecany, 25067
    Czechia

    Active - Recruiting

  • Neuroterapie KH Sro

    Kutná Hora, 28401
    Czechia

    Site Not Available

  • Psychiatric Ambulance

    Ostrava, 70868
    Czechia

    Site Not Available

  • A-Shine s.r.o.

    Plzen, 30100
    Czechia

    Site Not Available

  • Institut Neuropsychiatricke Pece

    Praha, 18600
    Czechia

    Active - Recruiting

  • Psychedelicka klinika, s.r.o.

    Praha, 16300
    Czechia

    Active - Recruiting

  • Aalborg Universitetshospital-Psykiatrien Region Nordjylland

    Aalborg, 9000
    Denmark

    Active - Recruiting

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

    Nîmes, 30000
    France

    Active - Recruiting

  • Centre Hospitalier Sainte Anne

    Paris, 75014
    France

    Site Not Available

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

    Paris, 75014
    France

    Active - Recruiting

  • Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique

    Paris, 75014
    France

    Active - Recruiting

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

    Paris, 75013
    France

    Active - Recruiting

  • Charite-Universitaetsmedizin Berlin

    Berlin, 12203
    Germany

    Active - Recruiting

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

    Frankfurt, 60528
    Germany

    Active - Recruiting

  • ZiP Campus Luebeck

    Luebeck, 23562
    Germany

    Active - Recruiting

  • Tallaght University Hospital

    Dublin, D24 NR0A
    Ireland

    Active - Recruiting

  • La Nua Day Hospital Mental Health Centre

    Galway, H91 VE03
    Ireland

    Terminated

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

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

    Leiden, 2300
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht (UMC Utrecht)

    Utrecht, 3584 CG
    Netherlands

    Active - Recruiting

  • Promente - Ośrodek Badań Klinicznych

    Bydgoszcz, 85-133
    Poland

    Active - Recruiting

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

    Gdańsk, 80-546
    Poland

    Active - Recruiting

  • Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych

    Gdańsk, 80-214
    Poland

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

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

    Barcelona, 08830
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • FIDMAG Hermanas Hospitalarias

    Sant Boi De Llobregat, 08830
    Spain

    Active - Recruiting

  • Hospital Universitario Río Hortega de Valladolid

    Valladolid, 47012
    Spain

    Active - Recruiting

  • Hospital Provincial de Zamora - Servicio de Psiquiatria

    Zamora, 49021
    Spain

    Active - Recruiting

  • Vuxenpsykiatrimottagningen

    Landskrona, 26153
    Sweden

    Active - Recruiting

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

    Lund, 22185
    Sweden

    Active - Recruiting

  • ClinSmart Sweden AB

    Solna, 17164
    Sweden

    Active - Recruiting

  • ProbarE

    Stockholm, 11239
    Sweden

    Active - Recruiting

  • Cornwall Partnership NHS Foundation Trust

    Bodmin, Cornwall PL31 2QT
    United Kingdom

    Active - Recruiting

  • Royal Edinburgh Hospital - NHS Lothian

    Edinburgh, Scotland EH10 5HF
    United Kingdom

    Site Not Available

  • Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust

    Chertsey, KT16 9AU
    United Kingdom

    Active - Recruiting

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

    Doncaster, DN4 8QN
    United Kingdom

    Active - Recruiting

  • Clinical Research Facility, Royal Devon and Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Active - Recruiting

  • Clerkenwell Health

    London, W1G 8DR
    United Kingdom

    Active - Recruiting

  • King's College London - Institute of Psychiatry, Psychology

    London, SE5 8AF
    United Kingdom

    Active - Recruiting

  • St. Pancras Clinical Research

    London, EC2Y 8EA
    United Kingdom

    Active - Recruiting

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

    Newcastle, NE4 5PL
    United Kingdom

    Active - Recruiting

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

    Nottingham, NG7 2TU
    United Kingdom

    Active - Recruiting

  • The Warneford Hospital- NIHR Clinical Research Facility

    Oxford, OX3 7JX
    United Kingdom

    Active - Recruiting

  • Cornwall Partnership NHS Foundation Trust and SW Peninsula Clinical Research Network

    Saltash, PL12 5LN
    United Kingdom

    Site Not Available

  • Sheffield Health and Social Care NHS Foundation Trust

    Sheffield, S10 3TH
    United Kingdom

    Active - Recruiting

  • Clinical Innovations, Inc.

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Active - Recruiting

  • CITrials

    Riverside, California 92506
    United States

    Terminated

  • Lumos Clinical Research Center

    San Jose, California 95124
    United States

    Active - Recruiting

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Pacific Clinical Research Management Group, LLC

    Upland, California 91786
    United States

    Active - Recruiting

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Behavioral Clinical Research, Inc.

    Miami Lakes, Florida 33016
    United States

    Terminated

  • Health Synergy Clinical Research

    Okeechobee, Florida 34972
    United States

    Active - Recruiting

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

    Orlando, Florida 32801
    United States

    Site Not Available

  • University South Florida

    Tampa, Florida 33613-4788
    United States

    Active - Recruiting

  • Atlanta Behavioral Research

    Atlanta, Georgia 30338
    United States

    Active - Recruiting

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Terminated

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612-3227
    United States

    Active - Recruiting

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • University Of Michigan Comprehensive Depression Center

    Ann Arbor, Michigan 48109-2700
    United States

    Active - Recruiting

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Princeton Medical Institute

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

  • Fieve Clinical Research, Inc

    New York, New York 10017
    United States

    Active - Recruiting

  • Spectrum Neuroscience and Treatment Institute

    New York, New York 10021-4157
    United States

    Active - Recruiting

  • Richmond Behavioral Associates

    Staten Island, New York 10312
    United States

    Terminated

  • University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic - Lutheran Hospital

    Cleveland, Ohio 44113-3108
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • The University of Texas at Austin - Dell Medical School

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Houston Clinical Trials, LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Center for Depression Research and Clinical Care

    Dallas, Texas 75247-9119
    United States

    Active - Recruiting

  • Relaro Medical Trials

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • North Texas Clinical Trials

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Brain Health Consultants and TMS Center

    Houston, Texas 77046-2401
    United States

    Active - Recruiting

  • HCA Healthcare Research Institute - Medical City Green Oaks Hospital

    Plano, Texas 75251
    United States

    Active - Recruiting

  • The University of Utah - Huntsman Mental Health Institute

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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