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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor will also be blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NMRA-335140 80 milligrams (mg) once daily (QD) 		Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD
  • Drug: NMRA-335140
    Participants will receive NMRA-335140 at a dose of 80 mg QD, orally
    Other names:
    • BTRX-335140
    • CYM-53093
    • Navacaprant
Placebo Comparator
Placebo 		Placebo participants will receive matching placebo tablet once daily
  • Drug: Placebo
    Placebo will be administered orally

Recruiting Locations

Neumora Investigator Site
Irvine 5359777, California 5332921 92614

Neumora Investigator Site
Long Beach 5367929, California 5332921 90807

Neumora Investigator Site
San Diego 5391811, California 5332921 92103

Neumora Investigator Site
San Francisco 5391959, California 5332921 94107

Neumora Investigator Site
New Haven 4839366, Connecticut 4831725 06520

Neumora Investigator Site
Brandon 4148757, Florida 4155751 33511

Neumora Investigator Site
Hialeah 4158476, Florida 4155751 33012

Neumora Investigator Site
Hialeah 4158476, Florida 4155751 33016

Neumora Investigator Site
Jacksonville 4160021, Florida 4155751 32256

Neumora Investigator Site
Miami 4164138, Florida 4155751 33165

Neumora Investigator site
Miami 4164138, Florida 4155751 33174

Neumora Investigator Site
Miami Beach 4164143, Florida 4155751 33140

Neumora Investigator site
Miami Springs 4164223, Florida 4155751 33166

Neumora Investigator Site
Pembroke Pines 4168139, Florida 4155751 33024

Neumora Investigator Site
Atlanta 4180439, Georgia 4197000 30328

Neumora Investigator Site
Decatur 4191124, Georgia 4197000 30030

Neumora Investigator Site
Savannah 4221552, Georgia 4197000 31405

Neumora Investigator Site
Springfield 4951788, Massachusetts 6254926 01103

Neumora Investigator Site
St Louis 4407066, Missouri 4398678 63141

Neumora Investigator Site
Berlin 4500771, New Jersey 5101760 08009

Neumora Investigator Site
New York 5128581, New York 5128638 10029

Neumora Investigator Site
New York 5128581, New York 5128638 10036

Neumora Investigator Site
Charlotte 4460243, North Carolina 4482348 28211

Neumora Investigator Site
Austin 4671654, Texas 4736286 78759

Neumora Investigator Site
DeSoto 4685524, Texas 4736286 75115

Neumora Investigator Site
Fort Worth 4691930, Texas 4736286 76104

More Details

Status
Recruiting
Sponsor
Neumora Therapeutics, Inc.

Study Contact

Study Contact
explore@koastalstudy.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.