NCT06029439

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Neumora Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	NMRA-335140	Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.

Timeline

• Start date: 2023-11-10
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-09-08
• Last updated: 2026-04-08

Locations

178 sites across 11 countries: United States, Brazil, Bulgaria, Canada, Chile, Czechia, Finland, France, Germany, Poland, Sweden

Regulatory

• FDA-regulated drug study