Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- NMRA-335140
- Conditions
- Major Depressive Disorder
- Sponsor
- Neumora Therapeutics, Inc.
- Enrollment
- 1000
- Locations
- 180
- Primary Endpoint
- Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: NMRA-335140
Outcomes
Primary Outcomes
Safety and tolerability assessments based on Treatment Emergent Adverse Events (TEAEs) and validated clinical scales
Time Frame: Up to 54 Weeks
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical and Ophthalmological examinations, Corneal Specular Microscopy, Columbia Suicide Severity Rating Scale (C-SSRS), and Sexual Functioning Questionnaire-14 (CSFQ-14) will be reported as TEAEs.
Secondary Outcomes
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score over time.(Baseline and up to Week 54)
- Change from Baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time(Baseline and up to Week 54)
- Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) total score over time.(Baseline and up to Week 54)
- Change from Baseline in PHQ-9 Anhedonia Item #1 over time.(Baseline and up to Week 54)
- Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score over time.(Baseline and up to Week 54)
- Change from Baseline in the Clinical Global Impression Scale of Severity (CGI-S)(Baseline and up to Week 54)
- Clinical Global Impression Scale of Improvement (CGI-I) score at each timepoint(Baseline and up to Week 54)
- Percentage of participants whose MADRS total score decreased by greater than or equal to 50% from Baseline over time(Up to Week 54)
- Percentage of participants whose MADRS total score decreased to 10 or less over time(Up to Week 54)
- Change from baseline in the Sheehan Disability Scale (SDS) over time(Baseline and up to Week 54)