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New depression drug shows promise in large trial

NCT ID NCT06029426

Symptom relief Sponsor: Neumora 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental oral drug, NMRA-335140, against a placebo in 383 adults with major depressive disorder. Participants took the drug or placebo daily for 6 weeks, and researchers measured changes in depression symptoms using a standard rating scale. The goal was to see if the drug could safely reduce depression better than a sugar pill.

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

383 people

The number who actually took part.

Started

Sep 2023

Finished

Jan 2025

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.

Key inclusion criteria: * Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode). * Participant's current major depressive episode must be confirmed by independent assessment. * The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit. * Have a MADRS total score of 25 or higher at Screening and Baseline. * A change in MADRS total score between Screening and Baseline of ≤20%. Key exclusion criteria: * Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode. * Currently or in the past year have been diagnosed with a personality disorder per the DSM-5-TR or in the past 3 years have been diagnosed with any of the following DSM-5-TR disorders: anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded. * Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or posttraumatic stress disorder (PTSD). * Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine). * Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. Participants who are currently hospitalized for MDD symptoms or suicidality are not allowed into the study. If there is a recent history (within 3 months of screening) of hospitalization due to MDD symptoms, the participant should be discussed with the Medical Monitor for eligibility.

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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

Contacts and locations

Locations

  • Neumora Investigator Site

    Garden Grove, California, 92845, United States

  • Neumora Investigator Site

    Glendale, California, 91206, United States

  • Neumora Investigator Site

    Imperial, California, 92251, United States

  • Neumora Investigator Site

    Lafayette, California, 94549, United States

  • Neumora Investigator Site

    Long Beach, California, 90807, United States

  • Neumora Investigator Site

    Los Angeles, California, 90015, United States

  • Neumora Investigator Site

    Oceanside, California, 92056, United States

  • Neumora Investigator Site

    Orange, California, 92868, United States

  • Neumora Investigator Site

    Riverside, California, 92506, United States

  • Neumora Investigator Site

    San Jose, California, 95124, United States

  • Neumora Investigator Site

    Sherman Oaks, California, 91403, United States

  • Neumora Investigator Site

    Temecula, California, 92591, United States

  • Neumora Investigator Site

    Torrance, California, 90504, United States

  • Neumora Investigator Site

    Colorado Springs, Colorado, 80910, United States

  • Neumora Investigator Site

    Gainesville, Florida, 32607, United States

  • Neumora Investigator Site

    Hallandale, Florida, 33009, United States

  • Neumora Investigator Site

    Jacksonville, Florida, 32256, United States

  • Neumora Investigator Site

    Lauderhill, Florida, 33319, United States

  • Neumora Investigator Site

    Maitland, Florida, 32751, United States

  • Neumora Investigator Site

    Miami, Florida, 33122, United States

  • Neumora Investigator Site

    Miami, Florida, 33125, United States

  • Neumora Investigator Site

    Miami, Florida, 33183, United States

  • Neumora Investigator Site

    Miami Lakes, Florida, 33016, United States

  • Neumora Investigator Site

    Orlando, Florida, 32801, United States

  • Neumora Investigator Site

    Tampa, Florida, 33607, United States

  • Neumora Investigator Site

    Marietta, Georgia, 30060, United States

  • Neumora Investigator Site

    Chicago, Illinois, 60634, United States

  • Neumora Investigator Site

    Evanston, Illinois, 60201, United States

  • Neumora Investigator Site

    Warrenville, Illinois, 60555, United States

  • Neumora Investigator Site

    Boston, Massachusetts, 02116, United States

  • Neumora Investigator Site

    Methuen, Massachusetts, 01844, United States

  • Neumora Investigator Site

    Watertown, Massachusetts, 02472, United States

  • Neumora Investigator Site

    Bloomfield Hills, Michigan, 48302, United States

  • Neumora Investigator Site

    Flowood, Mississippi, 39232, United States

  • Neumora Investigator Site

    Saint Charles, Missouri, 63304, United States

  • Neumora Investigator Site

    Las Vegas, Nevada, 89102, United States

  • Neumora Investigator Site

    Brooklyn, New York, 11224, United States

  • Neumora Investigator Site

    Cedarhurst, New York, 11516, United States

  • Neumora Investigator Site

    New York, New York, 10036, United States

  • Neumora Investigator Site

    Staten Island, New York, 10314, United States

  • Neumora Investigator Site

    Cleveland, Ohio, 44106, United States

  • Neumora Investigator Site

    Columbus, Ohio, 43210, United States

  • Neumora Investigator Site

    Dayton, Ohio, 45417, United States

  • Neumora Investigator Site

    Garfield Heights, Ohio, 44125, United States

  • Neumora Investigator Site

    Allentown, Pennsylvania, 18104, United States

  • Neumora Investigator Site

    Media, Pennsylvania, 19063, United States

  • Neumora Investigator Site

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Neumora Investigator Site

    Memphis, Tennessee, 38119, United States

  • Neumora Investigator Site

    Austin, Texas, 78737, United States

  • Neumora Investigator Site

    Dallas, Texas, 75235, United States

  • Neumora Investigator Site

    Houston, Texas, 77030, United States

  • Neumora Investigator Site

    Houston, Texas, 77090, United States

  • Neumora Investigator Site

    Wichita Falls, Texas, 76309, United States

  • Neumora Investigator Site

    Charlottesville, Virginia, 22903, United States

  • Neumora Investigator Site

    Bellevue, Washington, 98007, United States

  • Neumora Investigator Site

    Everett, Washington, 98201, United States

  • Neumora Investigator Site

    Huntsville, Alabama, 35801, United States

  • Neumora Investigator Site

    Phoenix, Arizona, 85012, United States

  • Neumora Investigator Site

    Bentonville, Arkansas, 72712, United States

  • Neumora Investigator Site

    Little Rock, Arkansas, 72211, United States

  • Neumora Investigator Site

    Rogers, Arkansas, 72758, United States

  • Neumora Investigator Site

    Bellflower, California, 90706, United States

  • Neumora Investigator Site #1

    Sherman Oaks, California, 91403, United States

  • Neumora Investigator Site-1

    Little Rock, Arkansas, 72211, United States

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