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Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder

NCT ID: NCT06058039

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2026-03-31

Brief Summary

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This randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Major Depressive Disorder NMRA-335140 Placebo-controlled Double-blind Navacaprant NMRA335140 NMRA 335140

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor will also be blinded

Study Groups

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NMRA-335140 80 milligrams (mg) once daily (QD)

Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD

Group Type EXPERIMENTAL

NMRA-335140

Intervention Type DRUG

Participants will receive NMRA-335140 at a dose of 80 mg QD, orally

Placebo

Placebo participants will receive matching placebo tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered orally

Interventions

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NMRA-335140

Participants will receive NMRA-335140 at a dose of 80 mg QD, orally

Intervention Type DRUG

Placebo

Placebo will be administered orally

Intervention Type DRUG

Other Intervention Names

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BTRX-335140 CYM-53093 Navacaprant

Eligibility Criteria

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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%.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neumora Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neumora Investigator Site

Cerritos, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Irvine, California, United States

Site Status RECRUITING

Neumora Investigator Site

Long Beach, California, United States

Site Status RECRUITING

Neumora Investigator Site

San Diego, California, United States

Site Status RECRUITING

Neumora Investigator Site

San Francisco, California, United States

Site Status RECRUITING

Neumora Investigator Site

New Haven, Connecticut, United States

Site Status RECRUITING

Neumora Investigator Site

Brandon, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hialeah, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hialeah, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Jacksonville, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami Beach, Florida, United States

Site Status RECRUITING

Neumora Investigator site

Miami Springs, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Palm Bay, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Pembroke Pines, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Pompano Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Saint Augustine, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Decatur, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Savannah, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Springfield, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator Site

St Louis, Missouri, United States

Site Status RECRUITING

Neumora Investigator Site

Omaha, Nebraska, United States

Site Status COMPLETED

Neumora Investigator Site

Berlin, New Jersey, United States

Site Status RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Staten Island, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Neumora Investigator Site

Austin, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

DeSoto, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Fort Worth, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Plano, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Cherven Bryag, Pleven, Bulgaria

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Kardzhali, , Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Pleven, , Bulgaria

Site Status COMPLETED

Neumora Investigator Site

Targovishte, , Bulgaria

Site Status RECRUITING

Neumora Investigator Site #1

Varna, , Bulgaria

Site Status COMPLETED

Neumora Investigator Site

Varna, , Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Pilsen, Plzen, Czechia

Site Status RECRUITING

Neumora Investigator Site

Prague, Prague, Czechia

Site Status RECRUITING

Neumora Investigator Site #1

Kladno, South Bohemian, Czechia

Site Status COMPLETED

Neumora Investigator Site

Kladno, , Czechia

Site Status RECRUITING

Neumora Investigator Site

Prague, , Czechia

Site Status COMPLETED

Neumora Investigator Site

Helsinki, Etelä-Suomen Lääni, Finland

Site Status RECRUITING

Neumora Investigator Site

Turku, Etelä-Suomen Lääni, Finland

Site Status COMPLETED

Neumora Investigator Site

Oulu, Oulun Lääni, Finland

Site Status RECRUITING

Neumora Investigator Site

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Neumora Investigator Site

Douai, Hauts-de-France, France

Site Status RECRUITING

Neumora Investigator Site

Montpellier, Hérault, France

Site Status RECRUITING

Neumora Investigator Site

Angers, Maine-et-Loire, France

Site Status RECRUITING

Neumora Investigator Site

La Roche-sur-Yon, Vendée, France

Site Status RECRUITING

Neumora Investigator Site

Poitiers, Vienne, France

Site Status RECRUITING

Neumora Investigator Site #1

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Hamburg, , Germany

Site Status RECRUITING

Neumora Investigator Site

Suchy Las, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Site Status COMPLETED

Neumora Investigator Site

Bialystok, Podlaskie Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Gdansk, Pomeranian Voivodeship, Poland

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Lund, Skåne County, Sweden

Site Status RECRUITING

Neumora Investigator Site

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Countries

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United States Bulgaria Czechia Finland France Germany Poland Sweden

Central Contacts

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Study Contact

Role: CONTACT

Email: [email protected]

Other Identifiers

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KOASTAL-3

Identifier Type: OTHER

Identifier Source: secondary_id

NMRA-335140-303

Identifier Type: -

Identifier Source: org_study_id