Clinical trial NCT06029426: Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
Official title: A Phase 3, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
NMRA-335140
Placebo-controlled
Double-blind
Navacaprant
NMRA335140
NMRA 335140
Lead sponsor: Neumora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Key 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%.

Key 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.

Primary outcomes:
measure: Change from Baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline and up to Week 6
Secondary outcomes:
measure: Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
timeFrame: Baseline and up to Week 6
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Neumora Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Neumora Investigator Site
state: Arizona
city: Bentonville
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Little Rock
country: United States
facility: Neumora Investigator Site-1
state: Arkansas
city: Little Rock
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Rogers
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Bellflower
country: United States
facility: Neumora Investigator Site
state: California
city: Garden Grove
country: United States
facility: Neumora Investigator Site
state: California
city: Glendale
country: United States
facility: Neumora Investigator Site
state: California
city: Imperial
country: United States
facility: Neumora Investigator Site
state: California
city: Lafayette
country: United States
facility: Neumora Investigator Site
state: California
city: Long Beach
country: United States
facility: Neumora Investigator Site
state: California
city: Los Angeles
country: United States
facility: Neumora Investigator Site
state: California
city: Oceanside
country: United States
facility: Neumora Investigator Site
state: California
city: Orange
country: United States
facility: Neumora Investigator Site
state: California
city: Riverside
country: United States
facility: Neumora Investigator Site
state: California
city: San Jose
country: United States
facility: Neumora Investigator Site
state: California
city: Sherman Oaks
country: United States
facility: Neumora Investigator Site #1
state: California
city: Sherman Oaks
country: United States
facility: Neumora Investigator Site
state: California
city: Temecula
country: United States
facility: Neumora Investigator Site
state: California
city: Torrance
country: United States
facility: Neumora Investigator Site
state: California
city: Colorado Springs
country: United States
facility: Neumora Investigator Site
state: Colorado
city: Gainesville
country: United States
facility: Neumora Investigator Site
state: Florida
city: Hallandale Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Neumora Investigator Site
state: Florida
city: Lauderhill
country: United States
facility: Neumora Investigator Site
state: Florida
city: Maitland
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Lakes
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Tampa
country: United States
facility: Neumora Investigator Site
state: Florida
city: Marietta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Chicago
country: United States
facility: Neumora Investigator Site
state: Illinois
city: Evanston
country: United States
facility: Neumora Investigator Site
state: Illinois
city: Warrenville
country: United States
facility: Neumora Investigator Site
state: Illinois
city: Boston
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Methuen
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Watertown
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neumora Investigator Site
state: Michigan
city: Flowood
country: United States
facility: Neumora Investigator Site
state: Mississippi
city: Saint Charles
country: United States
facility: Neumora Investigator Site
state: Missouri
city: Las Vegas
country: United States
facility: Neumora Investigator Site
state: Nevada
city: Brooklyn
country: United States
facility: Neumora Investigator Site
state: New York
city: Cedarhurst
country: United States
facility: Neumora Investigator Site
state: New York
city: New York
country: United States
facility: Neumora Investigator Site
state: New York
city: Staten Island
country: United States
facility: Neumora Investigator Site
state: New York
city: Cleveland
country: United States
facility: Neumora Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Neumora Investigator Site
state: Ohio
city: Dayton
country: United States
facility: Neumora Investigator Site
state: Ohio
city: Garfield Heights
country: United States
facility: Neumora Investigator Site
state: Ohio
city: Allentown
country: United States
facility: Neumora Investigator Site
state: Pennsylvania
city: Media
country: United States
facility: Neumora Investigator Site
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Neumora Investigator Site
state: Pennsylvania
city: Memphis
country: United States
facility: Neumora Investigator Site
state: Tennessee
city: Austin
country: United States
facility: Neumora Investigator Site
state: Texas
city: Dallas
country: United States
facility: Neumora Investigator Site
state: Texas
city: Houston
country: United States
facility: Neumora Investigator Site
state: Texas
city: Houston
country: United States
facility: Neumora Investigator Site
state: Texas
city: Wichita Falls
country: United States
facility: Neumora Investigator Site
state: Texas
city: Charlottesville
country: United States
facility: Neumora Investigator Site
state: Virginia
city: Bellevue
country: United States
facility: Neumora Investigator Site
state: Washington
city: Everett
country: United States
facility: Neumora Investigator Site
state: Washington
Study officials:
References: