Study to Assess the Safety and Effectiveness of NMRA-335140-501

NCT ID: NCT06029439

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2027-06-30

Brief Summary

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This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Major Depressive Disorder NMRA-335140 Long-term Safety Efficacy Navacaprant NMRA335140 NMRA 335140

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NMRA-335140 80 milligrams (mg) once daily (QD)

Participants will receive a NMRA-335140 tablet at a dose of 80 mg once daily (QD) during a 52-week treatment period.

Group Type EXPERIMENTAL

NMRA-335140

Intervention Type DRUG

Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.

Interventions

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NMRA-335140

Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.

Intervention Type DRUG

Other Intervention Names

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BTRX-335140 CYM-53093 Navacaprant

Eligibility Criteria

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Inclusion Criteria

* Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol.
* Signed an informed consent form (ICF) for this study.

Exclusion Criteria

* Diagnosed with another Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder that would have been exclusionary in the parent study (eg, personality disorder, bipolar 1 or 2, schizophrenia, any other psychotic disorder, or moderate or severe substance or alcohol use disorder \[excluding nicotine\]).
* Considered to be at significant risk of suicide in the judgment of the Investigator. This includes participants who are actively suicidal (eg, any suicide attempts during the parent study) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the C-SSRS ("Since Last Visit" version, score of "YES" on suicidal ideation Item 4 or 5) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.
* Non-adherent with study medication (took ≤70% of study drug over any 2-week visit interval) or procedures during the parent study.
* Experienced treatment emergent adverse events (TEAEs) considered related to the study medication from the parent study and judged by the Investigator to be clinically significant to render the participant ineligible for enrollment.
* Have an abnormality on ocular examination that would prohibit continued study participation as determined by the Investigator.
* Use of disallowed concomitant medication or therapy that would have been exclusionary in the parent study, may compromise the safety of the participant, and/or confound the interpretation of protocol assessments.
* Considered by the Investigator to be inappropriate for any other reason.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neumora Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neumora Investigator site

Huntsville, Alabama, United States

Site Status RECRUITING

Neumora Investigator Site

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Bentonville, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site #1

Little Rock, Arkansas, United States

Site Status COMPLETED

Neumora Investigator site

Little Rock, Arkansas, United States

Site Status RECRUITING

Neumora Investigator Site

Rogers, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator site

Bellflower, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Cerritos, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Encino, California, United States

Site Status RECRUITING

Neumora Investigator Site

Garden Grove, California, United States

Site Status RECRUITING

Neumora Investigator Site

Glendale, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Imperial, California, United States

Site Status RECRUITING

Neumora Investigator Site

Irvine, California, United States

Site Status RECRUITING

Neumora Investigator Site

Lafayette, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site #1

Long Beach, California, United States

Site Status RECRUITING

Neumora Investigator site

Long Beach, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Los Angeles, California, United States

Site Status RECRUITING

Neumora Investigator Site

Newport Beach, California, United States

Site Status RECRUITING

Neumora Investigator Site

Oceanside, California, United States

Site Status RECRUITING

Neumora Investigator Site #1

Orange, California, United States

Site Status RECRUITING

Neumora Investigator Site

Orange, California, United States

Site Status COMPLETED

Neumora Investigator Site

Riverside, California, United States

Site Status COMPLETED

Neumora Investigator Site

San Francisco, California, United States

Site Status RECRUITING

Neumora Investigator Site

San Jose, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Santa Ana, California, United States

Site Status COMPLETED

Neumora Investigator Site

Sherman Oaks, California, United States

Site Status RECRUITING

Neumora Investigator Site

Temecula, California, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Torrance, California, United States

Site Status RECRUITING

Neumora Investigator Site

Colorado Springs, Colorado, United States

Site Status COMPLETED

Neumora Investigator Site

Norwalk, Connecticut, United States

Site Status COMPLETED

Neumora Investigator Site

Bradenton, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Brandon, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Gainesville, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hallandale, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hialeah, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Hialeah, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Jacksonville, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Lauderhill, Florida, United States

Site Status RECRUITING

Neumora Investigator Site #1

Maitland, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Maitland, Florida, United States

Site Status RECRUITING

Neumora Investigator Site #1

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami, Florida, United States

Site Status RECRUITING

Neumora Investigator site

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Miami Beach, Florida, United States

Site Status RECRUITING

Neumora Investigator site

Miami Lakes, Florida, United States

Site Status RECRUITING

Neumora Investigator Site #1

Miami Lakes, Florida, United States

Site Status COMPLETED

Neumora Investigator Site #2

Miami Lakes, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Miami Springs, Florida, United States

Site Status RECRUITING

Neumora Investigator Site #1

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator site

Orlando, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Orlando, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Pembroke Pines, Florida, United States

Site Status RECRUITING

Neumora Investigator Site #1

Pompano Beach, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Pompano Beach, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Saint Augustine, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Tampa, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Tampa, Florida, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site #1

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Atlanta, Georgia, United States

Site Status COMPLETED

Neumora Investigator Site

Decatur, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Marietta, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Savannah, Georgia, United States

Site Status RECRUITING

Neumora Investigator Site

Chicago, Illinois, United States

Site Status RECRUITING

Neumora Investigator Site

Warrenville, Illinois, United States

Site Status RECRUITING

Neumora Investigator Site

Marrero, Louisiana, United States

Site Status COMPLETED

Neumora Investigator Site

New Orleans, Louisiana, United States

Site Status RECRUITING

Neumora Investigator Site

Baltimore, Maryland, United States

Site Status RECRUITING

Neumora Investigator site

Towson, Maryland, United States

Site Status RECRUITING

Neumora Investigator Site

Boston, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator Site

Boston, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator site

Methuen, Massachusetts, United States

Site Status COMPLETED

Neumora Investigator site

Springfield, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator Site

Watertown, Massachusetts, United States

Site Status RECRUITING

Neumora Investigator site

Bloomfield Township, Michigan, United States

Site Status COMPLETED

Neumora Investigator Site

Mankato, Minnesota, United States

Site Status RECRUITING

Neumora Investigator Site

Flowood, Mississippi, United States

Site Status RECRUITING

Neumora Investigator Site

Saint Charles, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

St Louis, Missouri, United States

Site Status RECRUITING

Neumora Investigator Site

Las Vegas, Nevada, United States

Site Status COMPLETED

Neumora Investigator Site

Berlin, New Jersey, United States

Site Status RECRUITING

Neumora Investigator site

Princeton, New Jersey, United States

Site Status RECRUITING

Neumora Investigator Site

Toms River, New Jersey, United States

Site Status RECRUITING

Neumora Investigator Site

Albuquerque, New Mexico, United States

Site Status RECRUITING

Neumora Investigator Site

Brooklyn, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Buffalo, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Cedarhurst, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Inwood, New York, United States

Site Status RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status RECRUITING

Neumora Investigator Site #1

New York, New York, United States

Site Status RECRUITING

Neumora Investigator Site

New York, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Staten Island, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Staten Island, New York, United States

Site Status COMPLETED

Neumora Investigator Site

The Bronx, New York, United States

Site Status RECRUITING

Neumora Investigator Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Neumora Investigator Site

Monroe, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Dayton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

North Canton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Edmond, Oklahoma, United States

Site Status RECRUITING

Neumora Investigator Site

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Neumora Investigator Site

Allentown, Pennsylvania, United States

Site Status RECRUITING

Neumora Investigator Site

Media, Pennsylvania, United States

Site Status COMPLETED

Neumora Investigator Site

Memphis, Tennessee, United States

Site Status RECRUITING

Neumora Investigator Site

Austin, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator site

Austin, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Dallas, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Fort Worth, Texas, United States

Site Status RECRUITING

Neumora Investigator Site #1

Houston, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Houston, Texas, United States

Site Status RECRUITING

Neumora Investigator Site

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Wichita Falls, Texas, United States

Site Status COMPLETED

Neumora Investigator Site

Bellevue, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site #1

Everett, Washington, United States

Site Status RECRUITING

Neumora Investigator Site

Everett, Washington, United States

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Curitiba, Paraná, Brazil

Site Status RECRUITING

Neumora Investigator Site

Botafogo - Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Neumora Investigator Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Neumora Investigator Site

Santa Cecília, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

São Bernardo do Campo, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Neumora Investigator Site

São Paulo, , Brazil

Site Status RECRUITING

Neumora Investigator Site

Cherven Bryag, Pleven, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Varosha, Targovishte, Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Kardzhali, , Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Pleven, , Bulgaria

Site Status COMPLETED

Neumora Investigator Site

Varna, , Bulgaria

Site Status RECRUITING

Neumora Investigator Site

Kelowna, British Columbia, Canada

Site Status RECRUITING

Neumora Investigator Site

Markham, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Mississauga, Ontario, Canada

Site Status RECRUITING

Neumora Investigator Site

Toronto, Ontario, Canada

Site Status RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Neumora Investigator Site

Antofagasta, , Chile

Site Status RECRUITING

Neumora Investigator Site

Pilsen, Plzeň, Czechia

Site Status RECRUITING

Neumora Investigator Site

Prague, Prague, Czechia

Site Status RECRUITING

Neumora Investigator Site

Kladno, South Bohemian, Czechia

Site Status COMPLETED

Neumora Investigator Site

Kladno, , Czechia

Site Status RECRUITING

Neumora Investigator Site

Prague, , Czechia

Site Status COMPLETED

Neumora Investigator Site

Helsinki, Etelä-Suomen Lääni, Finland

Site Status RECRUITING

Neumora Investigator Site

Turku, Etelä-Suomen Lääni, Finland

Site Status ACTIVE_NOT_RECRUITING

Neumora Investigator Site

Oulu, Oulun Lääni, Finland

Site Status RECRUITING

Neumora Investigator Site

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Neumora Investigator Site

Douai, Hauts-de-France, France

Site Status RECRUITING

Neumora Investigator Site

Montpellier, Hérault, France

Site Status RECRUITING

Neumora Investigator Site

La Roche-sur-Yon, Vendée, France

Site Status RECRUITING

Neumora Investigator Site

Poitiers, Vienne, France

Site Status RECRUITING

Neumora Investigator Site #1

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Berlin, , Germany

Site Status RECRUITING

Neumora Investigator Site

Hamburg, , Germany

Site Status RECRUITING

Neumora Investigator Site

Suchy Las, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Lublin, Lublin Voivodeship, Poland

Site Status COMPLETED

Neumora Investigator Site

Białystok, Podkarpackie Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Neumora Investigator Site

Lund, Skåne County, Sweden

Site Status RECRUITING

Neumora Investigator Site

Stockholm, Stolkholm Ian, Sweden

Site Status RECRUITING

Countries

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United States Brazil Bulgaria Canada Chile Czechia Finland France Germany Poland Sweden

Central Contacts

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Study Contact

Role: CONTACT

Email: [email protected]

Other Identifiers

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KOASTAL-LT

Identifier Type: OTHER

Identifier Source: secondary_id

NMRA-335140-501

Identifier Type: -

Identifier Source: org_study_id