Study to Assess the Safety and Effectiveness of NMRA-335140-501 (NCT06029439) | Clinical Trial Compass
RecruitingPhase 3
Study to Assess the Safety and Effectiveness of NMRA-335140-501
United States1,000 participantsStarted 2023-11-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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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…
What they're measuring
1
Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales