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New depression pill shows promise in Late-Stage trial

NCT ID NCT06058013

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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. Over 6 weeks, researchers measure changes in depression symptoms using standard rating scales. The goal is to see if the drug can safely reduce depression severity.

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

430 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 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 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

    Encino, California, 91316, United States

  • Neumora Investigator Site

    Garden Grove, California, 92845, United States

  • Neumora Investigator Site

    Los Alamitos, California, 90720, United States

  • Neumora Investigator Site

    Newport Beach, California, 92660, United States

  • Neumora Investigator Site

    Orange, California, 92868, United States

  • Neumora Investigator Site

    Santa Ana, California, 92704, United States

  • Neumora Investigator Site

    Norwalk, Connecticut, 06851, United States

  • Neumora Investigator Site

    Bradenton, Florida, 34205, United States

  • Neumora Investigator Site

    Hollywood, Florida, 33024, United States

  • Neumora Investigator Site

    Homestead, Florida, 33032, United States

  • Neumora Investigator Site

    Lauderhill, Florida, 33161, United States

  • Neumora Investigator Site

    Maitland, Florida, 32751, United States

  • Neumora Investigator Site

    Miami, Florida, 33126, United States

  • Neumora Investigator Site

    Miami, Florida, 33133, United States

  • Neumora Investigator Site

    Miami, Florida, 33137, United States

  • Neumora Investigator Site

    Miami, Florida, 33186, United States

  • Neumora Investigator Site

    Miami Lakes, Florida, 33014, United States

  • Neumora Investigator Site

    Miami Lakes, Florida, 33016, United States

  • Neumora Investigator Site

    Orlando, Florida, 32801, United States

  • Neumora Investigator Site

    Orlando, Florida, 32803, United States

  • Neumora Investigator Site

    Orlando, Florida, 32807, United States

  • Neumora Investigator Site

    Pinellas Park, Florida, 33782, United States

  • Neumora Investigator Site

    Pompano Beach, Florida, 33060, United States

  • Neumora Investigator Site

    Tampa, Florida, 33607, United States

  • Neumora Investigator Site

    Tampa, Florida, 33613, United States

  • Neumora Investigator Site

    Atlanta, Georgia, 30318, United States

  • Neumora Investigator Site

    Atlanta, Georgia, 30328, United States

  • Neumora Investigator Site

    Atlanta, Georgia, 30338, United States

  • Neumora Investigator Site

    Marrero, Louisiana, 70072, United States

  • Neumora Investigator Site

    New Orleans, Louisiana, 70115, United States

  • Neumora Investigator Site

    Baltimore, Maryland, 21208, United States

  • Neumora Investigator Site

    Towson, Maryland, 21204, United States

  • Neumora Investigator Site

    Boston, Massachusetts, 02116, United States

  • Neumora Investigator Site

    Boston, Massachusetts, 02131, United States

  • Neumora Investigator Site

    Watertown, Massachusetts, 02472, United States

  • Neumora Investigator Site

    Mankato, Minnesota, 56001, United States

  • Neumora Investigator Site

    Princeton, New Jersey, 08540, United States

  • Neumora Investigator Site

    Toms River, New Jersey, 08755, United States

  • Neumora Investigator Site

    Albuquerque, New Mexico, 87109, United States

  • Neumora Investigator Site

    Buffalo, New York, 14215, United States

  • Neumora Investigator Site

    Inwood, New York, 11096, United States

  • Neumora Investigator Site

    New York, New York, 10017, United States

  • Neumora Investigator Site

    The Bronx, New York, 10461, United States

  • Neumora Investigator Site

    Monroe, North Carolina, 28112, United States

  • Neumora Investigator Site

    North Canton, Ohio, 44720, United States

  • Neumora Investigator Site

    Oklahoma City, Oklahoma, 73118, United States

  • Neumora Investigator Site

    Philadelphia, Pennsylvania, 19104, United States

  • Neumora Investigator Site

    North Charleston, South Carolina, 29405, United States

  • Neumora Investigator Site

    Memphis, Tennessee, 38119, United States

  • Neumora Investigator Site

    Austin, Texas, 78737, United States

  • Neumora Investigator Site

    Dallas, Texas, 75243, United States

  • Neumora Investigator Site

    Houston, Texas, 77030, United States

  • Neumora Investigator Site

    Bellevue, Washington, 98007, United States

  • Neumora Investigator Site

    Everett, Washington, 98201, United States

  • Neumora Investigator Site

    Curitiba, Paraná, 80240280, Brazil

  • Neumora Investigator Site

    Porto Alegre, Rio Grande do Sul, 90610-001, Brazil

  • Neumora Investigator Site

    Santa Cecília, São Paulo, 01228-000, Brazil

  • Neumora Investigator Site

    São Bernardo do Campo, São Paulo, 09726150, Brazil

  • Neumora Investigator Site

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Neumora Investigator Site

    Rio de Janeiro, 22270-060, Brazil

  • Neumora Investigator Site

    São Paulo, 01236030, Brazil

  • Neumora Investigator Site

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Neumora Investigator Site

    Hamilton, Ontario, L8S 1B7, Canada

  • Neumora Investigator Site

    Toronto, Ontario, L5L 1W8, Canada

  • Neumora Investigator Site

    Toronto, Ontario, M5S 1M2, Canada

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Neumora Investigator Site

    Santiago, Santiago Metropolitan, 8330034, Chile

  • Neumora Investigator Site

    Antofagasta, 1270244, Chile

  • Neumora Investigator Site

    Santiago, 7560356, Chile

  • Neumora Investigator Site

    Santiago, 7561282, Chile

  • Neumora Investigator Site#1

    Tampa, Florida, 33613, United States

  • Neumora Investigator Sites

    Miami, Florida, 33122, United States

  • Neumora Investigator site

    Edmond, Oklahoma, 73013, United States

  • Neumora Investigator site

    Markham, Ontario, L3R 1A3, Canada

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