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Could a Psychedelic-Like pill beat depression? phase 3 trial underway

NCT ID NCT07592689

Symptom relief Sponsor: Definium Therapeutics US, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 11 times

Summary

This phase 3 study is testing an oral drug called DT120 (related to LSD) against a placebo in 165 adults with major depressive disorder. Participants will take the drug or placebo for 12 weeks, followed by a 40-week period where everyone can receive DT120. The main goal is to see if DT120 reduces depression symptoms more than placebo, measured by a standard depression scale.

What this could mean

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

Active substance
DT120 (lysergide tartrate, a psychoactive substance that affects serotonin receptors)
What this could lead to
If successful, this could provide a new oral treatment option for major depressive disorder, potentially easing symptoms more effectively than current therapies.
What could go wrong
This is a phase 3 trial, but results may still fail to show significant benefit over placebo. The psychoactive nature of DT120 may cause side effects, and long-term safety is not yet fully established.

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

About 165 people

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

Started

May 2026

Expected to finish

Jun 2028

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 to 74 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: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depressive disorder) 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine 4. Any clinically significant unstable illness

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • ATP Clinical Research Orange County

    NOT_YET_RECRUITING

    Orange, California, 92866, United States

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Harlem

    RECRUITING

    New York, New York, 10029, United States

  • Adams Clinical Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical Watertown

    RECRUITING

    Boston, Massachusetts, 02472, United States

  • Arch Clinical Trials, LLC

    NOT_YET_RECRUITING

    St Louis, Missouri, 63141, United States

  • Austin Clinical Trial Partners

    RECRUITING

    Austin, Texas, 78737, United States

  • Cedar Clinical Research

    RECRUITING

    Draper, Utah, 84020, United States

  • CenExel - Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • CenExel - iResearch Atlanta

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CenExel - iResearch Savannah

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Charter Research

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44113, United States

  • Clinical Neuroscience Solutions, LLC (Jacksonville)

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, LLC (Orlando)

    NOT_YET_RECRUITING

    Orlando, Florida, 32801, United States

  • Coastal Carolina Research

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Inner Space Research

    RECRUITING

    Orem, Utah, 84058, United States

  • K2 Medical Research (Maitland)

    NOT_YET_RECRUITING

    Maitland, Florida, 32751, United States

  • K2 Medical Research (Tampa)

    NOT_YET_RECRUITING

    Tampa, Florida, 33607, United States

  • Kadima Neuropsychiatry Institute

    RECRUITING

    San Diego, California, 92037, United States

  • Memory Clinic Inc.

    NOT_YET_RECRUITING

    Bennington, Vermont, 05201, United States

    Contact Email: •••••@•••••

  • Mountain View Clinical Research, Inc

    RECRUITING

    Denver, Colorado, 80209, United States

  • Preferred Research Partners, Inc.

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Psychedelic Science Institute

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact Email: •••••@•••••

  • Redbird Research

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Seattle Neuropsychiatric Treatment Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98104, United States

  • UCSF Department of Neurology

    NOT_YET_RECRUITING

    San Francisco, California, 94158, United States

  • Uptown Research Institute

    RECRUITING

    Chicago, Illinois, 60640, United States

  • VA Portland Healthcare System

    NOT_YET_RECRUITING

    Vancouver, Washington, 98661, United States

  • Vitalix Clinical

    RECRUITING

    Worcester, Massachusetts, 01608, United States

More trials for these conditions

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