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Magic mushroom compound takes on tough depression in major trial

NCT ID NCT05624268

Symptom relief Sponsor: COMPASS Pathways Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether a single dose of COMP360 psilocybin, given under supportive conditions, can safely reduce depression symptoms in 255 adults with treatment-resistant depression. Participants are randomly assigned to receive either the drug or a placebo, and their mood and daily functioning are tracked over time. The study aims to see if this psychedelic-assisted approach offers relief where standard treatments have failed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin (COMP360)
What this could lead to
If it works, this could offer a new, fast-acting option for people with depression that hasn't responded to other treatments.
What could go wrong
This is a single-dose study, and long-term effects are unknown. The psychedelic experience may cause temporary distress, and not everyone may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

258 people

The number who actually took part.

Started

Jan 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant depression

Contacts and locations

Locations

  • APG Research, LLC

    Orlando, Florida, 32803, United States

  • ASCLEPES Research Centers

    Thousand Oaks, California, 93012, United States

  • ATP Clinical Research, Inc.

    Orange, California, 92868, United States

  • Alivation Research, LLC.

    Lincoln, Nebraska, 68526, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • CBH Health, LLC

    Gaithersburg, Maryland, 20877, United States

  • CalNeuro Research Group, Inc

    Los Angeles, California, 90025, United States

  • California Center for Psychedelic Therapy

    Los Angeles, California, 90004, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • Clarity Clinical Research, LLC

    Los Angeles, California, 90064, United States

  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare

    Orlando, Florida, 32801, United States

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845, United States

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • DMI Health Care Group, Inc

    Tampa, Florida, 33782, United States

  • Emory University

    Atlanta, Georgia, 30329-2209, United States

  • Global Medical Institutes, LLC, Scranton Medical Institute

    Moosic, Pennsylvania, 18507, United States

  • Insight Clinical Trials, LLC

    Beachwood, Ohio, 44122, United States

  • Kadima Neuropsychiatry Institute

    La Jolla, California, 92037, United States

  • Lumos Clinical Research Center

    San Jose, California, 95124, United States

  • Meridien Research/Accel Research

    Tampa, Florida, 33803, United States

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Neuro-Behaviroral Clinical Research, Inc.

    North Canton, Ohio, 44720, United States

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

  • Pharmasite Research, Inc

    Pikesville, Maryland, 21208, United States

  • ProScience Research Group

    Culver City, California, 90230, United States

  • Psych Atlanta

    Atlanta, Georgia, 30060, United States

  • Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112, United States

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21044, United States

  • Stanford University

    Stanford, California, 94305, United States

  • The Medical Research Network, LLC

    New York, New York, 10128, United States

  • UT Health Science Center at Houston (UTHSC-H)

    Houston, Texas, 77030, United States

  • University California San Diego

    La Jolla, California, 92037, United States

  • University of Arizona College of Medicine - Tuscon

    Tuscon, Arizona, 85724, United States

  • University of Massachusetts Medical School

    North Worcester, Massachusetts, 01655, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55416, United States

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • Uptown Research Institute, LLC

    Chicago, Illinois, 60640, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.