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Magic mushroom compound psilocybin tested in major depression trial

NCT ID NCT06308653

Symptom relief Sponsor: Usona Institute 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether a single 25 mg dose of synthetic psilocybin can reduce depression symptoms in 238 adults with major depressive disorder. Participants receive either psilocybin or a placebo, and their depression severity is measured over 43 days. The trial also looks at safety and how long any benefits last, with optional repeat doses over a year.

What this could mean

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

Active substance
psilocybin (synthetic, 25 mg capsule)
What this could lead to
If successful, this could point toward a new, single-dose treatment option for major depression that reduces symptoms for weeks or longer.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The effect may be modest, not work for everyone, or have side effects like anxiety or nausea. Long-term benefits are uncertain.

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

238 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: * Adults ≥18 years old. * Able to swallow capsules. * If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study. * Meet the DSM-5-TR criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 60-day duration at the time of Screening. * Have at least moderate severity of depression symptoms at Screening and Trial Baseline. Exclusion Criteria: * Participants who are pregnant, who intend to become pregnant during the trial, or who are currently nursing. * Have any of the following cardiovascular conditions: coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, clinically-relevant valvular heart disease, pulmonary hypertension, myocardial infarction, a clinically significant ECG abnormality, or tachycardia. * Have elevated blood pressure. * Have neurological conditions such as stroke, including transient ischemic attack, epilepsy, neurodegenerative disease (e.g., dementia, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, etc.), or brain tumor. * Have severe hepatic or renal impairment. * Have uncontrolled diabetes mellitus or unstable existing thyroid disorder. * Are hepatitis or HIV positive. * Have a positive urine drug test for illicit, non-prescribed, or prohibited substances. * Meet DSM-5-TR criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features ,bipolar disorder (types 1 or 2), antisocial personality disorder, borderline personality disorder or moderate or severe alcohol or drug use disorder * Meet DSM-5-TR criteria for active post-traumatic stress disorder within 6 months prior to Screening. * Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar I disorder.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

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

Depressive disorder, major

Contacts and locations

Locations

  • AIM Trials, LLC

    Plano, Texas, 75093, United States

  • Bronx Veterans Research Foundation at the James J. Peters VAMC

    The Bronx, New York, 10468, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • Cedar Clinical Research, Inc.

    Murray, Utah, 84107, United States

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • Clinical Neuroscience Solutions Inc.

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • Connecticut Mental Health Center, Yale University

    New Haven, Connecticut, 06519, United States

  • Emory University

    Atlanta, Georgia, 30329, United States

  • Global Medical Institutes, LLC; Princeton Medical Institute

    Princeton, New Jersey, 08540, United States

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319, United States

  • Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research

    Baltimore, Maryland, 21224, United States

  • Kadima Neuropsychiatry Institute

    La Jolla, California, 92037, United States

  • Mountain View Clinical Research

    Denver, Colorado, 80209, United States

  • NYU Clinical & Translational Science Institute

    New York, New York, 10016, United States

  • Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners

    Santa Monica, California, 90404, United States

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • Preferred Research Partners-NWA, LLC

    Fayetteville, Arkansas, 72703, United States

  • Psychedelic Science Institute

    Santa Monica, California, 90404, United States

  • Seattle Neuropsychiatric Treatment Center

    Bellevue, Washington, 98004, United States

  • Sunstone Medical PC

    Rockville, Maryland, 20850, United States

  • University of Alabama Clinical Research Unit

    Birmingham, Alabama, 35209, United States

  • University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center

    Albuquerque, New Mexico, 87106, United States

  • VA Nebraska Western Iowa Health Care System

    Omaha, Nebraska, 68105, United States

  • VA Portland Health Care System

    Vancouver, Washington, 98661, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West LA VA Medical Center - Mental Health Department

    Los Angeles, California, 90073, United States

More trials for these conditions

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