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

NCT06029439 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: NMRA-335140-501KOASTAL-LT
• Study Type: interventional
• Target: 1,000
• Locations: 11 countries
• Sites: 178

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales

  An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical and Ophthalmological examinations, Corneal Specular Microscopy, Columbia Suicide Severity Rating Scale (C-SSRS), and Sexual Functioning Questionnaire-14 (CSFQ-14) will be reported as TEAEs.

  Up to 54 Weeks

Secondary Outcomes (10)

• Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time.

  Baseline and up to Week 54

• Change from Baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time

  Baseline and up to Week 54

• Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.

  Baseline and up to Week 54

• Change from Baseline in PHQ-9 Anhedonia Item #1 over time.

  Baseline and up to Week 54

• Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.

  Baseline and up to Week 54

Study Arms (1)

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

EXPERIMENTAL

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

Drug: NMRA-335140

Interventions

NMRA-335140 DRUG

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

Also known as: BTRX-335140, CYM-53093, Navacaprant

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Considered by the Investigator to be inappropriate for any other reason.

Sponsors & Collaborators

• Neumora Therapeutics, Inc.: lead

Study Sites (178)

Neumora Investigator site

Huntsville, Alabama, 35801, United States

RECRUITING

Neumora Investigator Site

Phoenix, Arizona, 85012, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Bentonville, Arkansas, 72712, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Little Rock, Arkansas, 72211, United States

COMPLETED

Neumora Investigator site

Little Rock, Arkansas, 72211, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Rogers, Arkansas, 72758, United States

COMPLETED

Neumora Investigator site

Bellflower, California, 90706, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Cerritos, California, 90703, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Encino, California, 91316, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Garden Grove, California, 92845, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Glendale, California, 91206, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Imperial, California, 92251, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Irvine, California, 92614, United States

RECRUITING

Neumora Investigator Site

Lafayette, California, 94549, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Long Beach, California, 90807, United States

RECRUITING

Neumora Investigator site

Long Beach, California, 90807, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Los Angeles, California, 90015, United States

RECRUITING

Neumora Investigator Site

Newport Beach, California, 92660, United States

RECRUITING

Neumora Investigator Site

Oceanside, California, 92056, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Orange, California, 92868, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Orange, California, 92868, United States

COMPLETED

Neumora Investigator Site

Riverside, California, 92506, United States

COMPLETED

Neumora Investigator Site

San Diego, California, 92103, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

San Francisco, California, 94107, United States

RECRUITING

Neumora Investigator Site

San Jose, California, 95124, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Santa Ana, California, 92704, United States

COMPLETED

Neumora Investigator Site

Sherman Oaks, California, 91403, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Temecula, California, 92591, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Torrance, California, 90504, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Colorado Springs, Colorado, 80910, United States

COMPLETED

Neumora Investigator Site

New Haven, Connecticut, 06520, United States

RECRUITING

Neumora Investigator Site

Norwalk, Connecticut, 06851, United States

COMPLETED

Neumora Investigator Site

Bradenton, Florida, 34205, United States

RECRUITING

Neumora Investigator Site

Brandon, Florida, 33511, United States

RECRUITING

Neumora Investigator Site

Gainesville, Florida, 32607, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Hallandale, Florida, 33009, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Hialeah, Florida, 33012, United States

RECRUITING

Neumora Investigator Site

Hialeah, Florida, 33016, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Hollywood, Florida, 33024, United States

RECRUITING

Neumora Investigator Site

Jacksonville, Florida, 32256, United States

RECRUITING

Neumora Investigator Site

Lauderhill, Florida, 33319, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Maitland, Florida, 32751, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Miami, Florida, 33122, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Miami, Florida, 33126, United States

RECRUITING

Neumora Investigator Site

Miami, Florida, 33133, United States

RECRUITING

Neumora Investigator Site

Miami, Florida, 33137, United States

RECRUITING

Neumora Investigator Site

Miami, Florida, 33143, United States

RECRUITING

Neumora Investigator Site

Miami, Florida, 33165, United States

RECRUITING

Neumora Investigator Site

Miami, Florida, 33174, United States

RECRUITING

Neumora Investigator site

Miami, Florida, 33183, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Miami Beach, Florida, 33140, United States

RECRUITING

Neumora Investigator site

Miami Lakes, Florida, 33014, United States

RECRUITING

Neumora Investigator Site #1

Miami Lakes, Florida, 33016, United States

COMPLETED

Neumora Investigator Site #2

Miami Lakes, Florida, 33016, United States

RECRUITING

Neumora Investigator Site

Miami Springs, Florida, 33166, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Orlando, Florida, 32801, United States

RECRUITING

Neumora Investigator site

Orlando, Florida, 32801, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Orlando, Florida, 32803, United States

RECRUITING

Neumora Investigator Site

Orlando, Florida, 32807, United States

RECRUITING

Neumora Investigator Site

Pembroke Pines, Florida, 33024, United States

RECRUITING

Neumora Investigator Site #1

Pompano Beach, Florida, 33060, United States

RECRUITING

Neumora Investigator Site

Pompano Beach, Florida, 33060, United States

RECRUITING

Neumora Investigator Site

Saint Augustine, Florida, 32086, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Tampa, Florida, 33607, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Tampa, Florida, 33613, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Tampa, Florida, 33613, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Atlanta, Georgia, 30318, United States

RECRUITING

Neumora Investigator Site #1

Atlanta, Georgia, 30328, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Atlanta, Georgia, 30328, United States

RECRUITING

Neumora Investigator Site

Atlanta, Georgia, 30338, United States

COMPLETED

Neumora Investigator Site

Decatur, Georgia, 30030, United States

RECRUITING

Neumora Investigator Site

Marietta, Georgia, 30060, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Savannah, Georgia, 31405, United States

RECRUITING

Neumora Investigator Site

Chicago, Illinois, 60634, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Warrenville, Illinois, 60555, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Marrero, Louisiana, 70072, United States

COMPLETED

Neumora Investigator Site

New Orleans, Louisiana, 70115, United States

RECRUITING

Neumora Investigator Site

Baltimore, Maryland, 21208, United States

RECRUITING

Neumora Investigator site

Towson, Maryland, 21204, United States

RECRUITING

Neumora Investigator Site

Boston, Massachusetts, 02116, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Boston, Massachusetts, 02131, United States

RECRUITING

Neumora Investigator site

Methuen, Massachusetts, 01844, United States

COMPLETED

Neumora Investigator site

Springfield, Massachusetts, 01103, United States

RECRUITING

Neumora Investigator Site

Watertown, Massachusetts, 02472, United States

ACTIVE NOT RECRUITING

Neumora Investigator site

Bloomfield Township, Michigan, 48302, United States

COMPLETED

Neumora Investigator Site

Mankato, Minnesota, 56001, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Flowood, Mississippi, 39232, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Saint Charles, Missouri, 63304, United States

COMPLETED

Neumora Investigator Site

St Louis, Missouri, 63141, United States

RECRUITING

Neumora Investigator Site

Las Vegas, Nevada, 89102, United States

COMPLETED

Neumora Investigator Site

Berlin, New Jersey, 08009, United States

RECRUITING

Neumora Investigator site

Princeton, New Jersey, 08540, United States

RECRUITING

Neumora Investigator Site

Toms River, New Jersey, 08755, United States

RECRUITING

Neumora Investigator Site

Albuquerque, New Mexico, 87109, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Brooklyn, New York, 11224, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Buffalo, New York, 14215, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Cedarhurst, New York, 11516, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Inwood, New York, 11096, United States

RECRUITING

Neumora Investigator Site

New York, New York, 10017, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

New York, New York, 10036, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Staten Island, New York, 10310, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Staten Island, New York, 10314, United States

COMPLETED

Neumora Investigator Site

The Bronx, New York, 10461, United States

RECRUITING

Neumora Investigator Site

Charlotte, North Carolina, 28211, United States

RECRUITING

Neumora Investigator Site

Monroe, North Carolina, 28112, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Dayton, Ohio, 45417, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

North Canton, Ohio, 44720, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Edmond, Oklahoma, 73013, United States

RECRUITING

Neumora Investigator Site

Oklahoma City, Oklahoma, 73118, United States

RECRUITING

Neumora Investigator Site

Allentown, Pennsylvania, 18104, United States

RECRUITING

Neumora Investigator Site

Media, Pennsylvania, 19063, United States

COMPLETED

Neumora Investigator Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Neumora Investigator Site

Memphis, Tennessee, 38119, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Austin, Texas, 78737, United States

ACTIVE NOT RECRUITING

Neumora Investigator site

Austin, Texas, 78759, United States

RECRUITING

Neumora Investigator Site

Dallas, Texas, 75243, United States

RECRUITING

Neumora Investigator Site

DeSoto, Texas, 75115, United States

RECRUITING

Neumora Investigator Site

Fort Worth, Texas, 76104, United States

RECRUITING

Neumora Investigator Site #1

Houston, Texas, 77030, United States

RECRUITING

Neumora Investigator Site

Houston, Texas, 77030, United States

COMPLETED

Neumora Investigator Site

Houston, Texas, 77090, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site

Wichita Falls, Texas, 76309, United States

COMPLETED

Neumora Investigator Site

Bellevue, Washington, 98007, United States

ACTIVE NOT RECRUITING

Neumora Investigator Site #1

Everett, Washington, 98201, United States

RECRUITING

Neumora Investigator Site

Curitiba, Paraná, 80240280, Brazil

RECRUITING

Neumora Investigator Site

Botafogo - Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil

RECRUITING

Neumora Investigator Site

Porto Alegre, Rio Grande do Sul, 90610-001, Brazil

ACTIVE NOT RECRUITING

Neumora Investigator Site

Santa Cecília, São Paulo, 01228-000, Brazil

RECRUITING

Neumora Investigator Site

São Bernardo do Campo, São Paulo, 09726150, Brazil

RECRUITING

Neumora Investigator Site

São José do Rio Preto, São Paulo, 15090-000, Brazil

ACTIVE NOT RECRUITING

Neumora Investigator Site

São Paulo, 01236030, Brazil

RECRUITING

Neumora Investigator Site

Cherven Bryag, Pleven, 5980, Bulgaria

ACTIVE NOT RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, 1408, Bulgaria

RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, 1463, Bulgaria

RECRUITING

Neumora Investigator Site

Sofia, Sofia-Grad, 1680, Bulgaria

ACTIVE NOT RECRUITING

Neumora Investigator Site

Varosha, Targovishte, 7700, Bulgaria

RECRUITING

Neumora Investigator Site

Kardzhali, 6600, Bulgaria

RECRUITING

Neumora Investigator Site

Pleven, 5800, Bulgaria

COMPLETED

Neumora Investigator Site

Varna, 9020, Bulgaria

ACTIVE NOT RECRUITING

Neumora Investigator Site

Kelowna, British Columbia, V1Y 1Z9, Canada

RECRUITING

Neumora Investigator Site

Hamilton, Ontario, L8S 1B7, Canada

ACTIVE NOT RECRUITING

Neumora Investigator Site

Markham, Ontario, L3R 1A3, Canada

COMPLETED

Neumora Investigator Site

Mississauga, Ontario, L5L 1W8, Canada

ACTIVE NOT RECRUITING

Neumora Investigator Site

Toronto, Ontario, M5S 1M2, Canada

ACTIVE NOT RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, 7500710, Chile

RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, 7560356, Chile

RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, 7561282, Chile

ACTIVE NOT RECRUITING

Neumora Investigator Site

Santiago, Santiago Metropolitan, 8330034, Chile

ACTIVE NOT RECRUITING

Neumora Investigator Site

Antofagasta, 1270244, Chile

RECRUITING

Neumora Investigator Site

Pilsen, Plzeň, 301 00, Czechia

RECRUITING

Neumora Investigator Site

Prague, Prague, 186 00, Czechia

RECRUITING

Neumora Investigator Site

Kladno, South Bohemian, 272 01, Czechia

COMPLETED

Neumora Investigator Site

Kladno, 272 01, Czechia

RECRUITING

Neumora Investigator Site

Prague, 109 00, Czechia

COMPLETED

Neumora Investigator Site

Helsinki, Etelä-Suomen Lääni, 00100, Finland

RECRUITING

Neumora Investigator Site

Turku, Etelä-Suomen Lääni, 20520, Finland

COMPLETED

Neumora Investigator Site

Oulu, Oulun Lääni, 90100, Finland

ACTIVE NOT RECRUITING

Neumora Investigator Site

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

ACTIVE NOT RECRUITING

Neumora Investigator Site

Douai, Hauts-de-France, 59500, France

RECRUITING

Neumora Investigator Site

Montpellier, Hérault, 34295, France

ACTIVE NOT RECRUITING

Neumora Investigator Site

La Roche-sur-Yon, Vendée, 85000, France

RECRUITING

Neumora Investigator Site

Poitiers, Vienne, 86000, France

COMPLETED

Neumora Investigator Site #1

Berlin, 10117, Germany

COMPLETED

Neumora Investigator Site

Berlin, 10117, Germany

ACTIVE NOT RECRUITING

Neumora Investigator Site

Berlin, 10629, Germany

RECRUITING

Neumora Investigator Site

Berlin, 13187, Germany

RECRUITING

Neumora Investigator Site

Hamburg, 20253, Germany

COMPLETED

Neumora Investigator Site

Suchy Las, Greater Poland Voivodeship, 62-002, Poland

RECRUITING

Neumora Investigator Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-133, Poland

RECRUITING

Neumora Investigator Site

Wroclaw, Lower Silesian Voivodeship, 50-414, Poland

RECRUITING

Neumora Investigator Site

Lublin, Lublin Voivodeship, 20-109, Poland

COMPLETED

Neumora Investigator Site

Lublin, Lublin Voivodeship, 20-582, Poland

COMPLETED

Neumora Investigator Site

Białystok, Podkarpackie Voivodeship, 15-879, Poland

RECRUITING

Neumora Investigator Site

Gdansk, Pomeranian Voivodeship, 80-438, Poland

COMPLETED

Neumora Investigator Site

Lund, Skåne County, 222 22, Sweden

RECRUITING

Neumora Investigator Site

Stockholm, Stolkholm Ian, 113 29, Sweden

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

BTRX-335140

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Study Contact

CONTACT

explore@koastalstudy.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3); US (126); BU (8); CZ (5); FR (5); BR (7); DE (5); CA (5); CL (5); PL (7); SE (2)