Study to Assess the Safety and Effectiveness of NMRA-335140-501
Trial Parameters
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.
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 ps