Clinical trial NCT06058039: Study to Assess the Effects of Oral NMRA-335140 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 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).


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 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.

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: Cerritos
country: United States
facility: Neumora Investigator Site
state: California
city: Irvine
country: United States
facility: Neumora Investigator Site
state: California
city: Long Beach
country: United States
facility: Neumora Investigator Site
state: California
city: San Diego
country: United States
facility: Neumora Investigator Site
state: California
city: San Francisco
country: United States
facility: Neumora Investigator Site
state: California
city: New Haven
country: United States
facility: Neumora Investigator Site
state: Connecticut
city: Brandon
country: United States
facility: Neumora Investigator Site
state: Florida
city: Hialeah
country: United States
facility: Neumora Investigator Site
state: Florida
city: Hialeah
country: United States
facility: Neumora Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Springs
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: Palm Bay
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pembroke Pines
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pompano Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Saint Augustine
country: United States
facility: Neumora Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Decatur
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Savannah
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Springfield
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Neumora Investigator Site
state: Missouri
city: Omaha
country: United States
facility: Neumora Investigator Site
state: Nebraska
city: Berlin
country: United States
facility: Neumora Investigator Site
state: New Jersey
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: Charlotte
country: United States
facility: Neumora Investigator Site
state: North Carolina
city: Austin
country: United States
facility: Neumora Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Neumora Investigator Site
state: Texas
city: Plano
country: United States
facility: Neumora Investigator Site
state: Texas
city: Cherven Bryag
country: Bulgaria
facility: Neumora Investigator Site
state: Pleven
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Sofia
country: Bulgaria
facility: Neumora Investigator Site
state: Sofia City
city: Kardzhali
country: Bulgaria
facility: Neumora Investigator Site
city: Pleven
country: Bulgaria
facility: Neumora Investigator Site
city: Targovishte
country: Bulgaria
facility: Neumora Investigator Site
city: Varna
country: Bulgaria
facility: Neumora Investigator Site #1
city: Varna
country: Bulgaria
facility: Neumora Investigator Site
city: Plzen 3
country: Czechia
facility: Neumora Investigator Site
state: Plzen
city: Prague
country: Czechia
facility: Neumora Investigator Site
state: Praha 8
city: Kladno
country: Czechia
facility: Neumora Investigator Site #1
state: South Bohemian
city: Kladno
country: Czechia
facility: Neumora Investigator Site
city: Prague
country: Czechia
facility: Neumora Investigator Site
city: Helsinki
country: Finland
facility: Neumora Investigator Site
state: Etelä-Suomen Lääni
city: Turku
country: Finland
facility: Neumora Investigator Site
state: Etelä-Suomen Lääni
city: Oulu
country: Finland
facility: Neumora Investigator Site
state: Oulun Lääni
city: Clermont-Ferrand
country: France
facility: Neumora Investigator Site
state: Auvergne-Rhône-Alpes
city: Douai
country: France
facility: Neumora Investigator Site
state: Hauts-de-France
city: Montpellier
country: France
facility: Neumora Investigator Site
state: Hérault
city: Angers
country: France
facility: Neumora Investigator Site
state: Maine-et-Loire
city: La Roche-sur-Yon
country: France
facility: Neumora Investigator Site
state: Vendée
city: Poitiers
country: France
facility: Neumora Investigator Site
state: Vienne
city: Berlin
country: Germany
facility: Neumora Investigator Site #1
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Berlin
country: Germany
facility: Neumora Investigator Site
city: Hamburg
country: Germany
facility: Neumora Investigator Site
city: Wrocław
country: Poland
facility: Neumora Investigator Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Neumora Investigator Site
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Neumora Investigator Site
state: Lubelskie
city: Lublin
country: Poland
facility: Neumora Investigator Site
state: Lubelskie
city: Białystok
country: Poland
facility: Neumora Investigator Site
state: Podlaskie
city: Gdańsk
country: Poland
facility: Neumora Investigator Site
state: Pomorskie
city: Suchy Las
country: Poland
facility: Neumora Investigator Site
state: Wielkopolskie
city: Lund
country: Sweden
facility: Neumora Investigator Site
state: Skåne Län
city: Stockholm
country: Sweden
facility: Neumora Investigator Site
state: Stockholms Län
Study officials:
References: