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Can a new pill lift the fog of depression?

NCT ID NCT07772531

Disease control Sponsor: Bristol-Myers Squibb 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether an experimental drug called BMS-986511 can reduce symptoms of major depressive disorder in adults. Participants with moderate to severe depression will receive either the drug or a placebo, and researchers will track changes in depression scores and any side effects. The goal is to see if this drug offers a safe and effective new way to manage depression.

What this could mean

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

Active substance
an experimental drug called BMS-986511 (also known as Evifacotrep)
What this could lead to
If successful, this could point toward a new treatment option for people with major depressive disorder who need better symptom relief.
What could go wrong
This is an early-phase trial with a modest number of participants, so results may not hold up in larger studies. The drug may also cause side effects, and not everyone may respond.

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

About 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 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 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: * Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview. * Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale. * Participant must have current MDE duration \>12 weeks at screening. * Outpatient participants able to comply with study procedures. * Participant require medication washout completed before baseline. * Participant must have BMI within protocol range. * Participants must meet reproductive safety requirements. Exclusion Criteria: * Participants must not have other primary psychiatric disorders or a history of treatment-resistant depression during the current episode. * Participants must not have recent history of active suicidal ideation or attempt within the past year. * Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation. * Participants must not have recent history of alcohol/substance abuse or use of cannabis. * Participants must not have significant ECG abnormalities, or poorly controlled diabetes. * Other protocol defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder mood 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 places running it

    27 sites in 2 countries. 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

  • Local Institution - 0003

    Everett, Washington, 98201, United States

  • Local Institution - 0005

    Kladno, 27201, Czechia

  • Local Institution - 0007

    Jacksonville, Florida, 32256, United States

  • Local Institution - 0016

    Dallas, Texas, 75231, United States

  • Local Institution - 0024

    Orlando, Florida, 32801, United States

  • Local Institution - 0027

    Oklahoma City, Oklahoma, 73116, United States

  • Local Institution - 0028

    Pilsen, 31200, Czechia

  • Local Institution - 0032

    Prague, Praha 8, 18600, Czechia

  • Local Institution - 0038

    Little Rock, Arkansas, 72211, United States

  • Local Institution - 0041

    Cedarhurst, New York, 11516, United States

  • Local Institution - 0042

    Glendale, California, 91206, United States

  • Local Institution - 0044

    Gaithersburg, Maryland, 20877, United States

  • Local Institution - 0046

    Garden Grove, California, 92845, United States

  • Local Institution - 0047

    Rogers, Arkansas, 72758, United States

  • Local Institution - 0050

    Upland, California, 91786, United States

  • Local Institution - 0069

    Mount Kisco, New York, 10549, United States

  • Local Institution - 0071

    Lemon Grove, California, 91945, United States

  • Local Institution - 0075

    Boston, Massachusetts, 02135, United States

  • Local Institution - 0079

    Oakland, California, 94607, United States

  • Local Institution - 0080

    Prague, Czech Republic, 10000, Czechia

  • Local Institution - 0081

    Klecany, 25067, Czechia

  • Local Institution - 0083

    Cincinnati, Ohio, 45219, United States

  • Local Institution - 0086

    Columbus, Ohio, 43210, United States

  • Local Institution - 0111

    Prague, Praha 6, 16000, Czechia

  • Local Institution - 0121

    Staten Island, New York, 10312, United States

  • Local Institution - 0140

    Atlanta, Georgia, 30331, United States

  • Local Institution - 0144

    Phoenix, Arizona, 85012, United States

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