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New depression drug shows promise but study halted early

NCT ID NCT04634669

Symptom relief Sponsor: Axsome Therapeutics, Inc. 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at the long-term safety and symptom relief of an experimental drug called AXS-05 in 181 adults with treatment-resistant depression (depression that hasn't improved with other treatments). Participants took the drug and were monitored for side effects and mood changes. The study was stopped early, so results are limited, but the goal was to see if AXS-05 could be a safe option for people who have not found relief from other antidepressants.

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

181 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2022

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.

* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features and with prior antidepressant treatment failure * Agree to use adequate method of contraception for the duration of the study * Additional criteria may apply

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Conditions

The condition(s) this trial relates to.

Depression Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

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

Major depressive disorder Treatment resistant depression

Contacts and locations

Locations

  • Clinical Research Site

    Little Rock, Arkansas, 72209, United States

  • Clinical Research Site

    Redlands, California, 92374, United States

  • Clinical Research Site

    Sherman Oaks, California, 91403, United States

  • Clinical Research Site

    Upland, California, 91786, United States

  • Clinical Research Site

    Miami, Florida, 33122, United States

  • Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Research Site

    Orlando, Florida, 32081, United States

  • Clinical Research Site

    Chicago, Illinois, 60634, United States

  • Clinical Research Site

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    Berlin, New Jersey, 08009, United States

  • Clinical Research Site

    Rochester, New York, 14618, United States

  • Clinical Research Site

    Staten Island, New York, 10312, United States

  • Clinical Research Site

    Hickory, North Carolina, 28601, United States

  • Clinical Research Site

    Raleigh, North Carolina, 27609, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45215, United States

  • Clinical Research Site

    Middleburg Heights, Ohio, 44130, United States

  • Clinical Research Site

    Media, Pennsylvania, 19063, United States

  • Clinical Research Site

    Dallas, Texas, 75243, United States

  • Clinical Research Site

    Friendswood, Texas, 77546, United States

  • Clinical Research Site

    Everett, Washington, 98201, United States

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