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

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 20.0Level: SOCClassification code: 10037175Term: Psychiatric disorders Class: 7; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-505892-56-00
• Lead Sponsor: eumora Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

Completed a previous NMRA-335140 Phase 3 MDD study (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. Note: For participants in the Czech Republic, every participant must have a caregiver participate in the study to help monitor compliance and safety during the study. The caregiver must be in personal contact with the participant at least 5 days a week in severely depressed participants or 2 days a week in moderately depressed participants and accompany the participant to study visits. The caregiver must sign a separate caregiver ICF., 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.

Exclusion Criteria

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 less than or equal to 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified