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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Huntsville

Neumora Investigator site, Huntsville, Alabama, United States, 35801

Phoenix

Neumora Investigator Site, Phoenix, Arizona, United States, 85012

Bentonville

Neumora Investigator Site, Bentonville, Arkansas, United States, 72712

Little Rock

Neumora Investigator site, Little Rock, Arkansas, United States, 72211

Rogers

Neumora Investigator Site, Rogers, Arkansas, United States, 72758

Bellflower

Neumora Investigator site, Bellflower, California, United States, 90706

Cerritos

Neumora Investigator Site, Cerritos, California, United States, 90703

Garden Grove

Neumora Investigator Site, Garden Grove, California, United States, 92845

Glendale

Neumora Investigator Site, Glendale, California, United States, 91206

Imperial

Neumora Investigator Site, Imperial, California, United States, 92251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neumora Therapeutics, Inc.,

Study Record Dates

2027-06