Clinical trial NCT06058013: Study to Assess 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: RECRUITING
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: 2023-09-28
Enrollment: 332
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, 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).


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 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.

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: Encino
country: United States
facility: Neumora Investigator Site
state: California
city: Garden Grove
country: United States
facility: Neumora Investigator Site
state: California
city: Los Alamitos
country: United States
facility: Neumora Investigator Site
state: California
city: Newport Beach
country: United States
facility: Neumora Investigator Site
state: California
city: Orange
country: United States
facility: Neumora Investigator Site
state: California
city: Santa Ana
country: United States
facility: Neumora Investigator Site
state: California
city: Norwalk
country: United States
facility: Neumora Investigator Site
state: Connecticut
city: Bradenton
country: United States
facility: Neumora Investigator Site
state: Florida
city: Homestead
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 Lakes
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Sites
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: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pinellas Park
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pompano Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Tampa
country: United States
facility: Neumora Investigator Site
state: Florida
city: Tampa
country: United States
facility: Neumora Investigator Site -2
state: Florida
city: Tampa
country: United States
facility: Neumora Investigator Site-1
state: Florida
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Marrero
country: United States
facility: Neumora Investigator Site
state: Louisiana
city: New Orleans
country: United States
facility: Neumora Investigator Site
state: Louisiana
city: Baltimore
country: United States
facility: Neumora Investigator Site
state: Maryland
city: Towson
country: United States
facility: Neumora Investigator Site
state: Maryland
city: Boston
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Watertown
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Mankato
country: United States
facility: Neumora Investigator Site
state: Minnesota
city: Princeton
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Toms River
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Albuquerque
country: United States
facility: Neumora Investigator Site
state: New Mexico
city: Bronx
country: United States
facility: Neumora Investigator Site
state: New York
city: Buffalo
country: United States
facility: Neumora Investigator Site
state: New York
city: Inwood
country: United States
facility: Neumora Investigator Site
state: New York
city: New York
country: United States
facility: Neumora Investigator Site #1
state: New York
city: Monroe
country: United States
facility: Neumora Investigator Site
state: North Carolina
city: North Canton
country: United States
facility: Neumora Investigator Site
state: Ohio
city: Edmond
country: United States
facility: Neumora Investigator site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Neumora Investigator Site
state: Oklahoma
city: North Charleston
country: United States
facility: Neumora Investigator Site
state: South Carolina
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: Bellevue
country: United States
facility: Neumora Investigator Site
state: Washington
city: Everett
country: United States
facility: Neumora Investigator Site
state: Washington
city: Curitaba
country: Brazil
facility: Neumora Investigator Site
state: Paraná
city: Porto Alegre
country: Brazil
facility: Neumora Investigator Site
state: Rio Grande Do Sul
city: Santa Cecília
country: Brazil
facility: Neumora Investigator Site
state: São Paulo
city: São Bernardo Do Campo
country: Brazil
facility: Neumora Investigator Site
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Neumora Investigator Site
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Neumora Investigator Site
city: São Paulo
country: Brazil
facility: Neumora Investigator Site
city: Kelowna
country: Canada
facility: Neumora Investigator Site
state: British Columbia
city: Hamilton
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Markham
country: Canada
facility: Neumora Investigator site
state: Ontario
city: Toronto
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Toronto
country: Canada
facility: Neumora Investigator Site
state: Ontario
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Neumora Investigator Site
state: Región Metropolitana De Santiago
city: Antofagasta
country: Chile
facility: Neumora Investigator Site
city: Santiago
country: Chile
facility: Neumora Investigator Site
Study officials:
References: