Study to Assess the Safety and Effectiveness of NMRA-335140-501
Launched by NEUMORA THERAPEUTICS, INC. · Sep 1, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, named NMRA-335140-501, is studying a new treatment called NMRA-335140 for people with Major Depressive Disorder (MDD). It is an extension of previous studies that looked at how well this treatment works and how safe it is. The trial lasts for 52 weeks and is open to individuals who have previously participated in related studies (NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) and are willing to continue the treatment. To join, participants must be between the ages of 65 and 74, provide consent, and meet specific health criteria.
If you or a loved one qualifies, you can expect to take NMRA-335140 while being monitored for safety and effectiveness throughout the year. Participants must also agree to follow certain rules regarding other medications and health conditions to ensure everyone’s safety. The trial is currently recruiting participants, so it’s a good opportunity for those looking for new treatment options for depression.
Gender
ALL
Eligibility criteria
- 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.
About Neumora Therapeutics, Inc.
Neumora Therapeutics, Inc. is a pioneering biopharmaceutical company focused on developing innovative therapies for neurodegenerative diseases. With a commitment to advancing precision medicine, Neumora leverages cutting-edge research and proprietary technology to identify and target the underlying mechanisms of neurological disorders. The company aims to address significant unmet medical needs by bringing forth novel treatment options that enhance the quality of life for patients. Through strategic collaborations and a robust pipeline, Neumora is dedicated to transforming the landscape of neurotherapeutics and improving patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Orlando, Florida, United States
Garden Grove, California, United States
Glendale, California, United States
Lafayette, California, United States
Long Beach, California, United States
Orange, California, United States
Riverside, California, United States
San Jose, California, United States
Colorado Springs, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Warrenville, Illinois, United States
Watertown, Massachusetts, United States
Flowood, Mississippi, United States
Brooklyn, New York, United States
Cedarhurst, New York, United States
Dayton, Ohio, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Bellevue, Washington, United States
Fort Worth, Texas, United States
Temecula, California, United States
Las Vegas, Nevada, United States
New York, New York, United States
Everett, Washington, United States
Phoenix, Arizona, United States
Rogers, Arkansas, United States
Oceanside, California, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
Saint Charles, Missouri, United States
Allentown, Pennsylvania, United States
Media, Pennsylvania, United States
Los Angeles, California, United States
Miami Lakes, Florida, United States
Marietta, Georgia, United States
Norwalk, Connecticut, United States
Monroe, North Carolina, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Berlin, New Jersey, United States
Huntsville, Alabama, United States
Little Rock, Arkansas, United States
Bellflower, California, United States
Sherman Oaks, California, United States
Torrance, California, United States
Miami, Florida, United States
Methuen, Massachusetts, United States
Columbus, Ohio, United States
Watertown, Massachusetts, United States
Towson, Maryland, United States
Princeton, New Jersey, United States
Toms River, New Jersey, United States
Oklahoma City, Oklahoma, United States
Cerritos, California, United States
Springfield, Massachusetts, United States
Imperial, California, United States
Wichita Falls, Texas, United States
Atlanta, Georgia, United States
Saint Louis, Missouri, United States
Charlotte, North Carolina, United States
Baltimore, Maryland, United States
Kelowna, British Columbia, Canada
Bentonville, Arkansas, United States
Hallandale Beach, Florida, United States
Staten Island, New York, United States
Houston, Texas, United States
Marrero, Louisiana, United States
Edmond, Oklahoma, United States
Markham, Ontario, Canada
Miami Springs, Florida, United States
Santa Ana, California, United States
New Orleans, Louisiana, United States
Toronto, Ontario, Canada
Bradenton, Florida, United States
North Canton, Ohio, United States
Hialeah, Florida, United States
Pembroke Pines, Florida, United States
Sofia, Sofia City, Bulgaria
Atlanta, Georgia, United States
Kardzhali, , Bulgaria
Montpellier, Hérault, France
Berlin, , Germany
Wrocław, Dolnoslaskie, Poland
Long Beach, California, United States
Orange, California, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Bloomfield Township, Michigan, United States
Pompano Beach, Florida, United States
Irvine, California, United States
Brandon, Florida, United States
Miami Beach, Florida, United States
Pleven, , Bulgaria
Varna, , Bulgaria
Kladno, South Bohemian, Czechia
Prague, , Czechia
Bydgoszcz, Kujawsko Pomorskie, Poland
Gdańsk, Pomorskie, Poland
Suchy Las, Wielkopolskie, Poland
Lund, Skåne Län, Sweden
Varosha, Targovishte, Bulgaria
Plzen 3, Plzeň, Czechia
Praha 8, Prague, Czechia
Kladno, , Czechia
Newport Beach, California, United States
Santiago, Región Metropolitana De Santiago, Chile
Cherven Bryag, Pleven, Bulgaria
Helsinki, Etelä Suomen Lääni, Finland
Oulu, Oulun Lääni, Finland
Douai, Hauts De France, France
Lublin, Lubelskie, Poland
Mississauga, Ontario, Canada
Stockholm, Stolkholm Ian, Sweden
Bronx, New York, United States
Antofagasta, , Chile
Turku, Etelä Suomen Lääni, Finland
New York, New York, United States
Varna, , Bulgaria
Białystok, Podkarpackie, Poland
Santa Cecília, São Paulo, Brazil
Santiago, Región Metropolitana De Santiago, Chile
La Roche Sur Yon, Vendée, France
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Maitland, Florida, United States
Pompano Beach, Florida, United States
Botafago Rio De Janeiro, , Brazil
Tampa, Florida, United States
Bellevue, Washington, United States
Botafago Rio De Janeiro, Rio De Janeiro, Brazil
Inwood, New York, United States
São Paulo, , Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Poitiers, Vienne, France
Clermont Ferrand Cedex 1, Auvergne Rhone Alpes, France
Miami Lakes, Florida, United States
Curitiba, Paraná, Brazil
Curitiba, , Brazil
Santa Cecília, , Brazil
Santiago, , Chile
Plzen 3, , Czechia
Helsinki, , Finland
Turku, , Finland
Oulu, , Finland
Montpellier, , France
La Roche Sur Yon, , France
Lund, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported