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

NCT ID: NCT06058013

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

2023-12-20

Study Completion Date

2026-06-30

Brief Summary

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This is a randomized, double-blind, placebo-controlled, multicenter study to 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 28 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 once daily (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 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.
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

Encino, California, United States

Site Status RECRUITING

Neumora Investigator Site

Garden Grove, California, United States

Site Status RECRUITING

Neumora Investigator Site

Los Alamitos, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Newport Beach, California, United States

Site Status RECRUITING

Neumora Investigator Site

Orange, California, United States

Site Status RECRUITING

Neumora Investigator Site

Santa Ana, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Norwalk, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Bradenton, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hollywood, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Homestead, Florida, United States

Site Status COMPLETED

Neumora Investigator Site

Lauderhill, Florida, United States

Site Status COMPLETED

Neumora Investigator Site

Maitland, Florida, United States

Site Status RECRUITING

Neumora Investigator Sites

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, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Miami Lakes, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Miami Lakes, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Pinellas Park, Florida, United States

Site Status COMPLETED

Neumora Investigator Site

Pompano Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Tampa, Florida, United States

Site Status RECRUITING

Neumora Investigator Site#1

Tampa, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Tampa, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status COMPLETED

Neumora Investigator Site

Marrero, Louisiana, United States

Site Status COMPLETED

Neumora Investigator Site

New Orleans, Louisiana, United States

Site Status RECRUITING

Neumora Investigator Site

Baltimore, Maryland, United States

Site Status RECRUITING

Neumora Investigator Site

Towson, Maryland, United States

Site Status RECRUITING

Neumora Investigator Site

Boston, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator Site

Boston, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator Site

Watertown, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Mankato, Minnesota, United States

Site Status RECRUITING

Neumora Investigator Site

Princeton, New Jersey, United States

Site Status RECRUITING

Neumora Investigator Site

Toms River, New Jersey, United States

Site Status RECRUITING

Neumora Investigator Site

Albuquerque, New Mexico, United States

Site Status RECRUITING

Neumora Investigator Site

Buffalo, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Inwood, New York, United States

Site Status RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

The Bronx, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Monroe, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

North Canton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator site

Edmond, Oklahoma, United States

Site Status RECRUITING

Neumora Investigator Site

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Neumora Investigator Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Neumora Investigator Site

North Charleston, South Carolina, United States

Site Status COMPLETED

Neumora Investigator Site

Memphis, Tennessee, United States

Site Status RECRUITING

Neumora Investigator Site

Austin, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Dallas, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Houston, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Bellevue, Washington, United States

Site Status RECRUITING

Neumora Investigator Site

Everett, Washington, United States

Site Status RECRUITING

Neumora Investigator Site

Curitiba, Paraná, Brazil

Site Status RECRUITING

Neumora Investigator Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Neumora Investigator Site

Santa Cecília, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

São Bernardo do Campo, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

Rio de Janeiro, , Brazil

Site Status RECRUITING

Neumora Investigator Site

São Paulo, , Brazil

Site Status RECRUITING

Neumora Investigator Site

Kelowna, British Columbia, Canada

Site Status RECRUITING

Neumora Investigator Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Neumora Investigator site

Markham, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Antofagasta, , Chile

Site Status RECRUITING

Neumora Investigator Site

Santiago, , Chile

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Santiago, , Chile

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Brazil Canada Chile

Central Contacts

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Study Contact

Role: CONTACT

Email: [email protected]

Other Identifiers

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KOASTAL-2

Identifier Type: OTHER

Identifier Source: secondary_id

NMRA-335140-302

Identifier Type: -

Identifier Source: org_study_id