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

Status: Recruiting
Location: See all (166) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Alabama
Neumora Investigator site
RECRUITING
Huntsville
Arkansas
Neumora Investigator Site
RECRUITING
Bentonville
Neumora Investigator site
RECRUITING
Little Rock
Neumora Investigator Site #1
COMPLETED
Little Rock
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Rogers
Arizona
Neumora Investigator Site
RECRUITING
Phoenix
California
Neumora Investigator site
RECRUITING
Bellflower
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Cerritos
Neumora Investigator Site
RECRUITING
Encino
Neumora Investigator Site
RECRUITING
Garden Grove
Neumora Investigator Site
RECRUITING
Glendale
Neumora Investigator Site
RECRUITING
Imperial
Neumora Investigator Site
RECRUITING
Irvine
Neumora Investigator Site
RECRUITING
Lafayette
Neumora Investigator site
RECRUITING
Long Beach
Neumora Investigator Site #1
RECRUITING
Long Beach
Neumora Investigator Site
RECRUITING
Los Angeles
Neumora Investigator Site
RECRUITING
Newport Beach
Neumora Investigator Site
RECRUITING
Oceanside
Neumora Investigator Site
COMPLETED
Orange
Neumora Investigator Site #1
RECRUITING
Orange
Neumora Investigator Site
COMPLETED
Riverside
Neumora Investigator Site
RECRUITING
San Francisco
Neumora Investigator Site
RECRUITING
San Jose
Neumora Investigator Site
COMPLETED
Santa Ana
Neumora Investigator Site
RECRUITING
Sherman Oaks
Neumora Investigator Site
RECRUITING
Temecula
Neumora Investigator Site
RECRUITING
Torrance
Colorado
Neumora Investigator Site
COMPLETED
Colorado Springs
Connecticut
Neumora Investigator Site
COMPLETED
Norwalk
Florida
Neumora Investigator Site
RECRUITING
Bradenton
Neumora Investigator Site
RECRUITING
Brandon
Neumora Investigator Site
RECRUITING
Gainesville
Neumora Investigator Site
RECRUITING
Hallandale
Neumora Investigator Site
RECRUITING
Hialeah
Neumora Investigator Site
RECRUITING
Hialeah
Neumora Investigator Site
RECRUITING
Jacksonville
Neumora Investigator Site
RECRUITING
Lauderhill
Neumora Investigator Site
RECRUITING
Maitland
Neumora Investigator Site #1
RECRUITING
Maitland
Neumora Investigator site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami
Neumora Investigator Site
RECRUITING
Miami Beach
Neumora Investigator site
RECRUITING
Miami Lakes
Neumora Investigator Site #1
COMPLETED
Miami Lakes
Neumora Investigator Site #2
COMPLETED
Miami Lakes
Neumora Investigator Site
RECRUITING
Miami Springs
Neumora Investigator site
RECRUITING
Orlando
Neumora Investigator Site
RECRUITING
Orlando
Neumora Investigator Site
RECRUITING
Orlando
Neumora Investigator Site #1
RECRUITING
Orlando
Neumora Investigator Site
RECRUITING
Pembroke Pines
Neumora Investigator Site
RECRUITING
Pompano Beach
Neumora Investigator Site #1
RECRUITING
Pompano Beach
Neumora Investigator Site
RECRUITING
Saint Augustine
Neumora Investigator Site
RECRUITING
Tampa
Georgia
Neumora Investigator Site
RECRUITING
Atlanta
Neumora Investigator Site
RECRUITING
Atlanta
Neumora Investigator Site
COMPLETED
Atlanta
Neumora Investigator Site #1
RECRUITING
Atlanta
Neumora Investigator Site
RECRUITING
Decatur
Neumora Investigator Site
RECRUITING
Marietta
Neumora Investigator Site
RECRUITING
Savannah
Illinois
Neumora Investigator Site
RECRUITING
Chicago
Neumora Investigator Site
RECRUITING
Warrenville
Louisiana
Neumora Investigator Site
COMPLETED
Marrero
Neumora Investigator Site
RECRUITING
New Orleans
Massachusetts
Neumora Investigator Site
RECRUITING
Boston
Neumora Investigator Site
RECRUITING
Boston
Neumora Investigator site
COMPLETED
Methuen
Neumora Investigator site
RECRUITING
Springfield
Neumora Investigator Site
RECRUITING
Watertown
Maryland
Neumora Investigator Site
RECRUITING
Baltimore
Neumora Investigator site
RECRUITING
Towson
Michigan
Neumora Investigator site
COMPLETED
Bloomfield Township
Minnesota
Neumora Investigator Site
RECRUITING
Mankato
Missouri
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Saint Charles
Neumora Investigator Site
RECRUITING
St Louis
Mississippi
Neumora Investigator Site
RECRUITING
Flowood
North Carolina
Neumora Investigator Site
RECRUITING
Charlotte
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Monroe
New Jersey
Neumora Investigator Site
RECRUITING
Berlin
Neumora Investigator site
RECRUITING
Princeton
Neumora Investigator Site
RECRUITING
Toms River
New Mexico
Neumora Investigator Site
RECRUITING
Albuquerque
Nevada
Neumora Investigator Site
COMPLETED
Las Vegas
New York
Neumora Investigator Site
RECRUITING
Brooklyn
Neumora Investigator Site
RECRUITING
Buffalo
Neumora Investigator Site
RECRUITING
Cedarhurst
Neumora Investigator Site
RECRUITING
Inwood
Neumora Investigator Site
RECRUITING
New York
Neumora Investigator Site
RECRUITING
New York
Neumora Investigator Site
RECRUITING
New York
Neumora Investigator Site
COMPLETED
Staten Island
Neumora Investigator Site
RECRUITING
Staten Island
Neumora Investigator Site
RECRUITING
The Bronx
Ohio
Neumora Investigator Site
RECRUITING
Columbus
Neumora Investigator Site
RECRUITING
Dayton
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
North Canton
Oklahoma
Neumora Investigator Site
RECRUITING
Edmond
Neumora Investigator Site
RECRUITING
Oklahoma City
Pennsylvania
Neumora Investigator Site
RECRUITING
Allentown
Neumora Investigator Site
COMPLETED
Media
Tennessee
Neumora Investigator Site
RECRUITING
Memphis
Texas
Neumora Investigator site
RECRUITING
Austin
Neumora Investigator Site
RECRUITING
Austin
Neumora Investigator Site
RECRUITING
Dallas
Neumora Investigator Site
RECRUITING
Fort Worth
Neumora Investigator Site
RECRUITING
Houston
Neumora Investigator Site
RECRUITING
Houston
Neumora Investigator Site #1
RECRUITING
Houston
Neumora Investigator Site
COMPLETED
Wichita Falls
Washington
Neumora Investigator Site
RECRUITING
Bellevue
Neumora Investigator Site
RECRUITING
Everett
Other Locations
Brazil
Neumora Investigator Site
RECRUITING
Botafago - Rio De Janeiro
Neumora Investigator Site
RECRUITING
Curitiba
Neumora Investigator Site
RECRUITING
Porto Alegre
Neumora Investigator Site
RECRUITING
Santa Cecília
Neumora Investigator Site
RECRUITING
São Bernardo Do Campo
Neumora Investigator Site
RECRUITING
São José Do Rio Preto
Neumora Investigator Site
RECRUITING
São Paulo
Bulgaria
Neumora Investigator Site
RECRUITING
Cherven Bryag
Neumora Investigator Site
RECRUITING
Kardzhali
Neumora Investigator Site
COMPLETED
Pleven
Neumora Investigator Site
RECRUITING
Sofia
Neumora Investigator Site
RECRUITING
Sofia
Neumora Investigator Site
RECRUITING
Sofia
Neumora Investigator Site
RECRUITING
Varna
Neumora Investigator Site
RECRUITING
Varosha
Canada
Neumora Investigator Site
RECRUITING
Kelowna
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Markham
Neumora Investigator Site
RECRUITING
Mississauga
Neumora Investigator Site
RECRUITING
Toronto
Chile
Neumora Investigator Site
RECRUITING
Antofagasta
Neumora Investigator Site
RECRUITING
Santiago
Neumora Investigator Site
RECRUITING
Santiago
Neumora Investigator Site
RECRUITING
Santiago
Neumora Investigator Site
RECRUITING
Santiago
Finland
Neumora Investigator Site
RECRUITING
Helsinki
Neumora Investigator Site
RECRUITING
Oulu
Neumora Investigator Site
ACTIVE_NOT_RECRUITING
Turku
France
Neumora Investigator Site
RECRUITING
Clermont-ferrand
Neumora Investigator Site
RECRUITING
Douai
Neumora Investigator Site
RECRUITING
La Roche-sur-yon
Neumora Investigator Site
RECRUITING
Montpellier
Neumora Investigator Site
RECRUITING
Poitiers
Germany
Neumora Investigator Site
RECRUITING
Berlin
Neumora Investigator Site
RECRUITING
Berlin
Neumora Investigator Site
RECRUITING
Berlin
Neumora Investigator Site #1
RECRUITING
Berlin
Neumora Investigator Site
RECRUITING
Hamburg
Poland
Neumora Investigator Site
RECRUITING
Białystok
Neumora Investigator Site
RECRUITING
Bydgoszcz
Neumora Investigator Site
RECRUITING
Gdansk
Neumora Investigator Site
RECRUITING
Lublin
Neumora Investigator Site
COMPLETED
Lublin
Neumora Investigator Site
RECRUITING
Suchy Las
Neumora Investigator Site
RECRUITING
Wroclaw
Sweden
Neumora Investigator Site
RECRUITING
Lund
Neumora Investigator Site
RECRUITING
Stockholm
Contact Information
Primary
Study Contact
explore@koastalstudy.com
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-06
Participants
Target number of participants: 1000
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Neumora Therapeutics, Inc.

This content was sourced from clinicaltrials.gov