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

NCT ID: NCT06029426

Last Updated: 2025-11-26

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2025-01-15

Brief Summary

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This is a randomized, double blind, placebo controlled, multi-center 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 extension study (NMRA-335140 501).

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Detailed Description

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Conditions

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Major Depressive Disorder

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 orally, once daily. Participants who complete the study may be eligible to participate in a separate 52-week open-label long term study.

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 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.
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

Huntsville, Alabama, United States

Site Status

Neumora Investigator Site

Phoenix, Arizona, United States

Site Status

Neumora Investigator Site

Bentonville, Arkansas, United States

Site Status

Neumora Investigator Site-1

Little Rock, Arkansas, United States

Site Status

Neumora Investigator Site

Little Rock, Arkansas, United States

Site Status

Neumora Investigator Site

Rogers, Arkansas, United States

Site Status

Neumora Investigator Site

Bellflower, California, United States

Site Status

Neumora Investigator Site

Garden Grove, California, United States

Site Status

Neumora Investigator Site

Glendale, California, United States

Site Status

Neumora Investigator Site

Imperial, California, United States

Site Status

Neumora Investigator Site

Lafayette, California, United States

Site Status

Neumora Investigator Site

Long Beach, California, United States

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Neumora Investigator Site

Los Angeles, California, United States

Site Status

Neumora Investigator Site

Oceanside, California, United States

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Neumora Investigator Site

Orange, California, United States

Site Status

Neumora Investigator Site

Riverside, California, United States

Site Status

Neumora Investigator Site

San Jose, California, United States

Site Status

Neumora Investigator Site #1

Sherman Oaks, California, United States

Site Status

Neumora Investigator Site

Sherman Oaks, California, United States

Site Status

Neumora Investigator Site

Temecula, California, United States

Site Status

Neumora Investigator Site

Torrance, California, United States

Site Status

Neumora Investigator Site

Colorado Springs, Colorado, United States

Site Status

Neumora Investigator Site

Gainesville, Florida, United States

Site Status

Neumora Investigator Site

Hallandale, Florida, United States

Site Status

Neumora Investigator Site

Jacksonville, Florida, United States

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Neumora Investigator Site

Lauderhill, Florida, United States

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Neumora Investigator Site

Maitland, Florida, United States

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Neumora Investigator Site

Miami, Florida, United States

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Neumora Investigator Site

Miami, Florida, United States

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Neumora Investigator Site

Miami, Florida, United States

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Neumora Investigator Site

Miami Lakes, Florida, United States

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Neumora Investigator Site

Orlando, Florida, United States

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Neumora Investigator Site

Tampa, Florida, United States

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Neumora Investigator Site

Marietta, Georgia, United States

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Neumora Investigator Site

Chicago, Illinois, United States

Site Status

Neumora Investigator Site

Evanston, Illinois, United States

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Neumora Investigator Site

Warrenville, Illinois, United States

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Neumora Investigator Site

Boston, Massachusetts, United States

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Neumora Investigator Site

Methuen, Massachusetts, United States

Site Status

Neumora Investigator Site

Watertown, Massachusetts, United States

Site Status

Neumora Investigator Site

Bloomfield Hills, Michigan, United States

Site Status

Neumora Investigator Site

Flowood, Mississippi, United States

Site Status

Neumora Investigator Site

Saint Charles, Missouri, United States

Site Status

Neumora Investigator Site

Las Vegas, Nevada, United States

Site Status

Neumora Investigator Site

Brooklyn, New York, United States

Site Status

Neumora Investigator Site

Cedarhurst, New York, United States

Site Status

Neumora Investigator Site

New York, New York, United States

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Neumora Investigator Site

Staten Island, New York, United States

Site Status

Neumora Investigator Site

Cleveland, Ohio, United States

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Neumora Investigator Site

Columbus, Ohio, United States

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Neumora Investigator Site

Dayton, Ohio, United States

Site Status

Neumora Investigator Site

Garfield Heights, Ohio, United States

Site Status

Neumora Investigator Site

Allentown, Pennsylvania, United States

Site Status

Neumora Investigator Site

Media, Pennsylvania, United States

Site Status

Neumora Investigator Site

Plymouth Meeting, Pennsylvania, United States

Site Status

Neumora Investigator Site

Memphis, Tennessee, United States

Site Status

Neumora Investigator Site

Austin, Texas, United States

Site Status

Neumora Investigator Site

Dallas, Texas, United States

Site Status

Neumora Investigator Site

Houston, Texas, United States

Site Status

Neumora Investigator Site

Houston, Texas, United States

Site Status

Neumora Investigator Site

Wichita Falls, Texas, United States

Site Status

Neumora Investigator Site

Charlottesville, Virginia, United States

Site Status

Neumora Investigator Site

Bellevue, Washington, United States

Site Status

Neumora Investigator Site

Everett, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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KOASTAL-1

Identifier Type: OTHER

Identifier Source: secondary_id

NMRA-335140-301

Identifier Type: -

Identifier Source: org_study_id

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