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NCT06029439

PHASE3

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

Sponsor: Neumora Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

904

Start Date

2023-11-10

Completion Date

2026-08-17

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Major Depressive Disorder

Interventions

DRUG

NMRA-335140

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

Key Inclusion Criteria: Rollover participants are eligible for the study if the following inclusion criteria are met: * 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. * Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol. * Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the parent study protocol. Key Exclusion Criteria: Rollover participants are excluded from the study if any of the following exclusion criteria are met: * 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.

Locations (178)

Neumora Investigator site

Huntsville, Alabama, United States

Neumora Investigator Site

Phoenix, Arizona, United States

Neumora Investigator Site

Bentonville, Arkansas, United States

Neumora Investigator Site #1

Little Rock, Arkansas, United States

Neumora Investigator site

Little Rock, Arkansas, United States

Neumora Investigator Site

Rogers, Arkansas, United States

Neumora Investigator site

Bellflower, California, United States

Neumora Investigator Site

Cerritos, California, United States

Neumora Investigator Site

Encino, California, United States

Neumora Investigator Site

Garden Grove, California, United States

Neumora Investigator Site

Glendale, California, United States

Neumora Investigator Site

Imperial, California, United States

Neumora Investigator Site

Irvine, California, United States

Neumora Investigator Site

Lafayette, California, United States

Neumora Investigator Site #1

Long Beach, California, United States

Neumora Investigator site

Long Beach, California, United States

Neumora Investigator Site

Los Angeles, California, United States

Neumora Investigator Site

Newport Beach, California, United States

Neumora Investigator Site

Oceanside, California, United States

Neumora Investigator Site #1

Orange, California, United States

Neumora Investigator Site

Orange, California, United States

Neumora Investigator Site

Riverside, California, United States

Neumora Investigator Site

San Diego, California, United States

Neumora Investigator Site

San Francisco, California, United States

Neumora Investigator Site

San Jose, California, United States

Neumora Investigator Site

Santa Ana, California, United States

Neumora Investigator Site

Sherman Oaks, California, United States

Neumora Investigator Site

Temecula, California, United States

Neumora Investigator Site

Torrance, California, United States

Neumora Investigator Site

Colorado Springs, Colorado, United States

Neumora Investigator Site

New Haven, Connecticut, United States

Neumora Investigator Site

Norwalk, Connecticut, United States

Neumora Investigator Site

Bradenton, Florida, United States

Neumora Investigator Site

Brandon, Florida, United States

Neumora Investigator Site

Gainesville, Florida, United States

Neumora Investigator Site

Hallandale, Florida, United States

Neumora Investigator Site

Hialeah, Florida, United States

Neumora Investigator Site

Hialeah, Florida, United States

Neumora Investigator Site

Hollywood, Florida, United States

Neumora Investigator Site

Jacksonville, Florida, United States

Neumora Investigator Site

Lauderhill, Florida, United States

Neumora Investigator Site

Maitland, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator Site

Miami, Florida, United States

Neumora Investigator site

Miami, Florida, United States

Neumora Investigator Site

Miami Beach, Florida, United States

Neumora Investigator site

Miami Lakes, Florida, United States

Neumora Investigator Site #1

Miami Lakes, Florida, United States

Neumora Investigator Site #2

Miami Lakes, Florida, United States

Neumora Investigator Site

Miami Springs, Florida, United States

Neumora Investigator Site #1

Orlando, Florida, United States

Neumora Investigator site

Orlando, Florida, United States

Neumora Investigator Site

Orlando, Florida, United States

Neumora Investigator Site

Orlando, Florida, United States

Neumora Investigator Site

Pembroke Pines, Florida, United States

Neumora Investigator Site #1

Pompano Beach, Florida, United States

Neumora Investigator Site

Pompano Beach, Florida, United States

Neumora Investigator Site

Saint Augustine, Florida, United States

Neumora Investigator Site

Tampa, Florida, United States

Neumora Investigator Site #1

Tampa, Florida, United States

Neumora Investigator Site

Tampa, Florida, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site #1

Atlanta, Georgia, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Atlanta, Georgia, United States

Neumora Investigator Site

Decatur, Georgia, United States

Neumora Investigator Site

Marietta, Georgia, United States

Neumora Investigator Site

Savannah, Georgia, United States

Neumora Investigator Site

Chicago, Illinois, United States

Neumora Investigator Site

Warrenville, Illinois, United States

Neumora Investigator Site

Marrero, Louisiana, United States

Neumora Investigator Site

New Orleans, Louisiana, United States

Neumora Investigator Site

Baltimore, Maryland, United States

Neumora Investigator site

Towson, Maryland, United States

Neumora Investigator Site

Boston, Massachusetts, United States

Neumora Investigator Site

Boston, Massachusetts, United States

Neumora Investigator site

Methuen, Massachusetts, United States

Neumora Investigator site

Springfield, Massachusetts, United States

Neumora Investigator Site

Watertown, Massachusetts, United States

Neumora Investigator site

Bloomfield Township, Michigan, United States

Neumora Investigator Site

Mankato, Minnesota, United States

Neumora Investigator Site

Flowood, Mississippi, United States

Neumora Investigator Site

Saint Charles, Missouri, United States

Neumora Investigator Site

St Louis, Missouri, United States

Neumora Investigator Site

Las Vegas, Nevada, United States

Neumora Investigator Site

Berlin, New Jersey, United States

Neumora Investigator site

Princeton, New Jersey, United States

Neumora Investigator Site

Toms River, New Jersey, United States

Neumora Investigator Site

Albuquerque, New Mexico, United States

Neumora Investigator Site

Brooklyn, New York, United States

Neumora Investigator Site

Buffalo, New York, United States

Neumora Investigator Site

Cedarhurst, New York, United States

Neumora Investigator Site

Inwood, New York, United States

Neumora Investigator Site

New York, New York, United States

Neumora Investigator Site

New York, New York, United States

And 78 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (178)