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Magic mushroom compound shows promise for depression in large trial

NCT ID NCT03866174

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a single 25 mg dose of psilocybin, the active ingredient in magic mushrooms, could reduce depression symptoms better than a placebo (niacin). 347 adults with major depressive disorder received either psilocybin or niacin in a double-blind setup. The main goal was to measure changes in depression scores 43 days after dosing.

What this could mean

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

Active substance
psilocybin (a psychedelic compound)
What this could lead to
If successful, this could point toward a new, fast-acting treatment for major depression that works after just one dose.
What could go wrong
This is a mid-stage trial, so results may not confirm lasting benefit. The psychedelic effects can be intense and require careful supervision.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

347 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2022

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

21 to 65 years

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: * 21 to 65 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 * Have an identified support person and agree to be accompanied home by that person following dosing * Have sustained moderate-severe depression symptoms at Screening and Baseline * Meet DSM-5 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 Exclusion Criteria: * Women who are pregnant or who intend to become pregnant during the study or who are currently nursing * Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition * Have a history of stroke or Transient Ischemic Attack (TIA) * Have moderate to severe hepatic impairment * Have epilepsy * Have insulin-dependent diabetes * Have a positive urine drug test * Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period * Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder * Meet DSM-5 criteria for antisocial personality disorder * Meet DSM-5 criteria for a moderate or severe alcohol or drug use 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

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640, United States

  • Hassman Research Institute

    Berlin, New Jersey, 08009, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21229, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • Pacific Neuroscience Institute

    Santa Monica, California, 91404, United States

  • Segal Trials

    Lauderhill, Florida, 33319, United States

  • University of California, San Francisco

    San Francisco, California, 94121, United States

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53706, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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