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Treatment Resistant DepressionPhase 3NCT05711940

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

A Phase 3 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 116 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment Resistant Depression
What is being tested?
Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
572 participants
Where
116 sitesin 12 countries
Study dates
14 Feb 2023to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

116 sites in 12 countries.

116 sites in 12 countries

United States62 sites

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York, 14226-1727

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • University Of Michigan Comprehensive Depression Center

    Ann Arbor, Michigan, 48109-2700

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • The University of Texas at Austin - Dell Medical School

    Austin, Texas, 78712

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401

  • Clinical Innovations, Inc.

    Bellflower, California, 90706

  • Harvard Medical School - McLean Hospital

    Belmont, Massachusetts, 02478-1064

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Adams Clinical - Boston (Copley Clinical)

    Boston, Massachusetts, 02116

  • Rush University Medical Center

    Chicago, Illinois, 60612-3227

  • Uptown Research Institute, LLC

    Chicago, Illinois, 60640

  • University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience

    Cincinnati, Ohio, 45219

  • Cleveland Clinic - Lutheran Hospital

    Cleveland, Ohio, 44113-3108

  • The Ohio State University

    Columbus, Ohio, 43210

  • Relaro Medical Trials

    Dallas, Texas, 75243

  • Center for Depression Research and Clinical Care

    Dallas, Texas, 75247-9119

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Cedar Clinical Research

    Draper, Utah, 84020

  • Institute for Integrative Therapies

    Eden Prairie, Minnesota, 55347

  • M3 Wake Research

    Encino, California, 91316

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Lighthouse Psychiatry Scottsdale

    Gilbert, Arizona, 85234

  • Brain Health Consultants and TMS Center

    Houston, Texas, 77046-2401

  • The Regents of the University of California - San Diego

    La Jolla, California, 92037-1337

  • Kadima Neuropsychiatry Institute

    La Jolla, California, 92037

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • Alivation Research, LLC.

    Lincoln, Nebraska, 68526

  • CalNeuro Research Group, Inc

    Los Angeles, California, 90025

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Central Miami Medical Institute, LLC

    Miami, Florida, 33125

  • Behavioral Clinical Research, Inc.

    Miami Lakes, Florida, 33016

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Fieve Clinical Research, Inc

    New York, New York, 10017

  • Spectrum Neuroscience and Treatment Institute

    New York, New York, 10021-4157

  • Adams Clinical - New York

    New York, New York, 10029

  • New York State Psychiatric Institute

    New York, New York, 10032

  • University of Massachusetts Medical School

    North Worcester, Massachusetts, 01655

  • Piedmont Hospital Neuroscience Centre

    Oakland, California, 94610

  • Health Synergy Clinical Research

    Okeechobee, Florida, 34972

  • ATP Clinical Research, Inc.

    Orange, California, 92868

  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

    Orlando, Florida, 32801

  • APG Research, LLC- Advanced Psychiatric Group

    Orlando, Florida, 32803

  • HCA Healthcare Research Institute - Medical City Green Oaks Hospital

    Plano, Texas, 75251

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • CITrials

    Riverside, California, 92506

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63304

  • The University of Utah - Huntsman Mental Health Institute

    Salt Lake City, Utah, 84108

  • Lumos Clinical Research Center

    San Jose, California, 95124

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington, 98104

  • Psychiatric Medicine Associates

    Skokie, Illinois, 60076

  • Stanford University

    Stanford, California, 94305

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • University South Florida

    Tampa, Florida, 33613-4788

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Adams Clinical - New York

    The Bronx, New York, 10461

  • ASCLEPES Research Centers

    Thousand Oaks, California, 93012

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Pacific Clinical Research Management Group, LLC

    Upland, California, 91786

  • Adams Clinical - Boston

    Watertown, Massachusetts, 02472

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407

Other trials in United States

United Kingdom13 sites

  • Cornwall Partnership NHS Foundation Trust

    Bodmin, Cornwall, PL31 2QT

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

    Chertsey, KT16 9AU

  • St. Pancras Clinical Research

    Chester, CH2 1HX

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

    Doncaster, DN4 8QN

  • Clinical Research Facility, Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust

    Fulbourn, CB21 5EF

  • St. Pancras Clinical Research

    London, EC2Y 8EA

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

    London, SE5 8AF

  • Clerkenwell Health

    London, W1G 8DR

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

    Newcastle, NE4 5PL

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

    Nottingham, NG7 2TU

  • The Warneford Hospital- NIHR Clinical Research Facility

    Oxford, OX3 7JX

  • Sheffield Health and Social Care NHS Foundation Trust

    Sheffield, S10 3TH

Other trials in United Kingdom

Canada9 sites

  • Chatham-Kent Clnical Trials Centre

    Chatham, Ontario

  • Medical Arts Health Research Centre, Kamloops

    Kamloops, British Columbia

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • Medical Arts Research Group - Penticton

    Penticton, British Columbia, V2A 5L5

  • Diex Recherche Sherbrooke Inc.

    Québec, B.C., J1L 0H8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario

  • Centre for Neurology Studies

    Vancouver

  • Medical Arts Research Group

    Vancouver

Other trials in Canada

Czechia6 sites

  • National Institute of Mental Health

    Klecany, 25067

  • Neuroterapie KH Sro

    Kutná Hora, 28401

  • Psychiatric Ambulance

    Ostrava, 70868

  • A-Shine s.r.o.

    Pilsen, 30100

  • Psychedelicka klinika, s.r.o.

    Prague, 16300

  • Institut Neuropsychiatricke Pece

    Prague, 18600

Other trials in Czechia

Spain6 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

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

    Barcelona, 08830

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • FIDMAG Hermanas Hospitalarias

    Sant Boi de Llobregat, 08830

  • Hospital Universitario Río Hortega de Valladolid

    Valladolid, 47012

  • Hospital Provincial de Zamora - Servicio de Psiquiatria

    Zamora, 49021

Other trials in Spain

France4 sites

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

    Nîmes, 30000

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

    Paris, Paris, 75014

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

    Paris, 75013

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

    Paris, 75014

Other trials in France

Sweden4 sites

  • Vuxenpsykiatrimottagningen

    Landskrona, 26153

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

    Lund, 22185

  • ClinSmart Sweden AB

    Solna, 17164

  • Hälsoklustret

    Stockholm, 11239

Other trials in Sweden

Germany3 sites

  • Charite-Universitaetsmedizin Berlin

    Berlin, 12203

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

    Frankfurt, 60528

  • ZiP Campus Luebeck

    Lübeck, 23562

Other trials in Germany

Netherlands3 sites

  • University Medical Center Groningen

    Groningen, 9713 GZ

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

    Leiden, 2300

  • Universitair Medisch Centrum Utrecht (UMC Utrecht)

    Utrecht, 3584 CG

Other trials in Netherlands

Poland3 sites

  • Promente - Ośrodek Badań Klinicznych

    Bydgoszcz, 85-133

  • Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych

    Gdansk, 80-214

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

    Gdansk, 80-546

Other trials in Poland

Ireland2 sites

  • Tallaght University Hospital

    Dublin, D24 NR0A

  • La Nua Day Hospital Mental Health Centre

    Galway, H91 VE03

Other trials in Ireland

Denmark1 site

  • Aalborg Universitetshospital-Psykiatrien Region Nordjylland

    Aalborg, 9000

Other trials in Denmark

About this study

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

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

Read the detailed 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 comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week screening period.

Part A will include a nine-week follow-up from initial investigational product (IP) administration.

Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration.

Part C will include a further 26 weeks follow-up out to 52 weeks from initial 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.

Being tested
Psilocybin
Keywords
psilocybin
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    Also called COMP360

    COMP360 Psilocybin administered under supportive conditions

Study groups in NCT05711940
Study groupRoleWhat they receive
25 mg COMP360 PsilocybinExperimental25 mg COMP360 Psilocybin
Receives: Drug: Psilocybin
10 mg COMP360 PsilocybinExperimental10 mg COMP360 Psilocybin
Receives: Drug: Psilocybin
1 mg COMP360 PsilocybinActive comparator1 mg COMP360 Psilocybin, active comparator
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 6

Secondary outcomes (3)

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

    Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.

    Measured: Week 6

  2. COMP360 25 mg versus COMP360 10 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

    Measured: Week 6

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

    Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2023
  2. Study start14 Feb 2023
  3. Primary completion13 Nov 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05711940
Sponsor's protocol ID
COMP 006
Status last verified
Apr 2026
First submitted
25 Jan 2023
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Psilocybin in people with Treatment Resistant Depression, run by COMPASS Pathways at 116 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, United Kingdom, Canada, Czechia, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score. (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05711940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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