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

Purpose

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).

Condition

  • Major Depressive Disorder

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 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.

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 once daily (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
Encino 5346649, California 5332921 91316

Neumora Investigator Site
Garden Grove 5351515, California 5332921 92845

Neumora Investigator Site
Newport Beach 5376890, California 5332921 92660

Neumora Investigator Site
Orange 5379513, California 5332921 92868

Neumora Investigator Site
Bradenton 4148708, Florida 4155751 34205

Neumora Investigator Site
Hollywood 4158928, Florida 4155751 33024

Neumora Investigator Site
Maitland 4163220, Florida 4155751 32751

Neumora Investigator Sites
Miami 4164138, Florida 4155751 33122

Neumora Investigator Site
Miami 4164138, Florida 4155751 33126

Neumora Investigator Site
Miami 4164138, Florida 4155751 33137

Neumora Investigator Site
Orlando 4167147, Florida 4155751 32801

Neumora Investigator Site
Orlando 4167147, Florida 4155751 32803

Neumora Investigator Site
Orlando 4167147, Florida 4155751 32807

Neumora Investigator Site
Tampa 4174757, Florida 4155751 33607

Neumora Investigator Site#1
Tampa 4174757, Florida 4155751 33613

Neumora Investigator Site
Atlanta 4180439, Georgia 4197000 30318

Neumora Investigator Site
Atlanta 4180439, Georgia 4197000 30328

Neumora Investigator Site
New Orleans 4335045, Louisiana 4331987 70115

Neumora Investigator Site
Baltimore 4347778, Maryland 4361885 21208

Neumora Investigator Site
Towson 4371582, Maryland 4361885 21204

Neumora Investigator Site
Boston 4930956, Massachusetts 6254926 02116

Neumora Investigator Site
Boston 4930956, Massachusetts 6254926 02131

Neumora Investigator Site
Princeton 5102922, New Jersey 5101760 08540

Neumora Investigator Site
Toms River 4504476, New Jersey 5101760 08755

Neumora Investigator Site
Albuquerque 5454711, New Mexico 5481136 87109

Neumora Investigator Site
Buffalo 5110629, New York 5128638 14215

Neumora Investigator Site
Inwood 5122280, New York 5128638 11096

Neumora Investigator Site
The Bronx 5110266, New York 5128638 10461

Neumora Investigator site
Edmond 4535740, Oklahoma 4544379 73013

Neumora Investigator Site
Oklahoma City 4544349, Oklahoma 4544379 73118

Neumora Investigator Site
Philadelphia 4560349, Pennsylvania 6254927 19104

Neumora Investigator Site
Memphis 4641239, Tennessee 4662168 38119

Neumora Investigator Site
Austin 4671654, Texas 4736286 78737

Neumora Investigator Site
Dallas 4684888, Texas 4736286 75243

Neumora Investigator Site
Bellevue 5786882, Washington 5815135 98007

Neumora Investigator Site
Everett 5793933, Washington 5815135 98201

More Details

Status
Recruiting
Sponsor
Neumora Therapeutics, Inc.

Study Contact

Study Contact
explore@koastalstudy.com