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New depression pill shows promise in Late-Stage trial

NCT ID NCT06058039

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study tests an experimental oral medication, NMRA-335140, against a placebo in 332 adults with major depressive disorder. The goal is to see if the drug reduces depression symptoms over 6 weeks. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors know which they receive.

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

422 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2026

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 post-traumatic 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 (eg, 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 ideations 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

    Cerritos, California, 90703, United States

  • Neumora Investigator Site

    Irvine, California, 92614, United States

  • Neumora Investigator Site

    Long Beach, California, 90807, United States

  • Neumora Investigator Site

    San Diego, California, 92103, United States

  • Neumora Investigator Site

    San Francisco, California, 94107, United States

  • Neumora Investigator Site

    New Haven, Connecticut, 06520, United States

  • Neumora Investigator Site

    Brandon, Florida, 33511, United States

  • Neumora Investigator Site

    Hialeah, Florida, 33012, United States

  • Neumora Investigator Site

    Hialeah, Florida, 33016, United States

  • Neumora Investigator Site

    Jacksonville, Florida, 32256, United States

  • Neumora Investigator Site

    Miami, Florida, 33143, United States

  • Neumora Investigator Site

    Miami, Florida, 33165, United States

  • Neumora Investigator Site

    Miami Beach, Florida, 33140, United States

  • Neumora Investigator Site

    Palm Bay, Florida, 32905, United States

  • Neumora Investigator Site

    Pembroke Pines, Florida, 33024, United States

  • Neumora Investigator Site

    Pompano Beach, Florida, 33060, United States

  • Neumora Investigator Site

    Saint Augustine, Florida, 32086, United States

  • Neumora Investigator Site

    Atlanta, Georgia, 30328, United States

  • Neumora Investigator Site

    Decatur, Georgia, 30030, United States

  • Neumora Investigator Site

    Savannah, Georgia, 31405, United States

  • Neumora Investigator Site

    Springfield, Massachusetts, 01103, United States

  • Neumora Investigator Site

    St Louis, Missouri, 63141, United States

  • Neumora Investigator Site

    Omaha, Nebraska, 68112, United States

  • Neumora Investigator Site

    Berlin, New Jersey, 08009, United States

  • Neumora Investigator Site

    New York, New York, 10029, United States

  • Neumora Investigator Site

    New York, New York, 10036, United States

  • Neumora Investigator Site

    Staten Island, New York, 10310, United States

  • Neumora Investigator Site

    Charlotte, North Carolina, 28211, United States

  • Neumora Investigator Site

    Austin, Texas, 78759, United States

  • Neumora Investigator Site

    DeSoto, Texas, 75115, United States

  • Neumora Investigator Site

    Fort Worth, Texas, 76104, United States

  • Neumora Investigator Site

    Plano, Texas, 75093, United States

  • Neumora Investigator Site

    Cherven Bryag, Pleven, 5980, Bulgaria

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1408, Bulgaria

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1463, Bulgaria

  • Neumora Investigator Site

    Sofia, Sofia-Grad, 1680, Bulgaria

  • Neumora Investigator Site

    Kardzhali, 6600, Bulgaria

  • Neumora Investigator Site

    Pleven, 5800, Bulgaria

  • Neumora Investigator Site

    Targovishte, 7700, Bulgaria

  • Neumora Investigator Site

    Varna, 9020, Bulgaria

  • Neumora Investigator Site

    Pilsen, Plzen, 301 00, Czechia

  • Neumora Investigator Site

    Prague, Prague, 186 00, Czechia

  • Neumora Investigator Site

    Kladno, 272 01, Czechia

  • Neumora Investigator Site

    Prague, 109 00, Czechia

  • Neumora Investigator Site

    Helsinki, Etelä-Suomen Lääni, 00100, Finland

  • Neumora Investigator Site

    Turku, Etelä-Suomen Lääni, 20520, Finland

  • Neumora Investigator Site

    Oulu, Oulun Lääni, 90100, Finland

  • Neumora Investigator Site

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

  • Neumora Investigator Site

    Douai, Hauts-de-France, 59500, France

  • Neumora Investigator Site

    Montpellier, Hérault, 34295, France

  • Neumora Investigator Site

    Angers, Maine-et-Loire, 49100, France

  • Neumora Investigator Site

    La Roche-sur-Yon, Vendée, 85000, France

  • Neumora Investigator Site

    Poitiers, Vienne, 86000, France

  • Neumora Investigator Site

    Berlin, 10117, Germany

  • Neumora Investigator Site

    Berlin, 10629, Germany

  • Neumora Investigator Site

    Berlin, 13187, Germany

  • Neumora Investigator Site

    Hamburg, 20253, Germany

  • Neumora Investigator Site

    Suchy Las, Greater Poland Voivodeship, 62-002, Poland

  • Neumora Investigator Site

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-133, Poland

  • Neumora Investigator Site

    Wroclaw, Lower Silesian Voivodeship, 50-414, Poland

  • Neumora Investigator Site

    Lublin, Lublin Voivodeship, 20-109, Poland

  • Neumora Investigator Site

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Neumora Investigator Site

    Bialystok, Podlaskie Voivodeship, 15-879, Poland

  • Neumora Investigator Site

    Gdansk, Pomeranian Voivodeship, 80-438, Poland

  • Neumora Investigator Site

    Lund, Skåne County, 222 22, Sweden

  • Neumora Investigator Site

    Stockholm, Stockholm County, 113 29, Sweden

  • Neumora Investigator Site #1

    Varna, 9020, Bulgaria

  • Neumora Investigator Site #1

    Kladno, South Bohemian, 272 01, Czechia

  • Neumora Investigator Site #1

    Berlin, 10117, Germany

  • Neumora Investigator site

    Miami, Florida, 33174, United States

  • Neumora Investigator site

    Miami Springs, Florida, 33166, United States

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