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Magic mushroom compound takes on PTSD in major new trial

NCT ID NCT07570654

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests whether COMP360, a lab-made psilocybin, can reduce PTSD symptoms when given with professional support. About 300 adults with PTSD will receive either a high or low dose and be followed for 8 weeks. The goal is to see if the drug safely eases symptoms like flashbacks and anxiety.

What this could mean

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

Active substance
COMP360 psilocybin (a lab-made form of the active compound in magic mushrooms)
What this could lead to
If it works, this could offer a new treatment option that reduces PTSD symptoms with just a few monitored sessions.
What could go wrong
This is still in testing; the lower dose control group may also show improvement, and psilocybin can cause temporary anxiety or confusion. Long-term benefits are not yet known.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

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.

Inclusion Criteria: * 18 years or older * Diagnosed with PTSD at least 6 months ago Exclusion Criteria: \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions

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Conditions

The condition(s) this trial relates to.

combat disorder injury post-traumatic stress disorder

As listed by the trial registrant

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

PTSD PTSD - post traumatic stress disorder PTSD symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida

    RECRUITING

    Orlando, Florida, 32801, United States

  • NY

    RECRUITING

    New York, New York, 10025, United States

More trials for these conditions

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