NCT06058013

Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Neumora Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	NMRA-335140	Participants will receive NMRA-335140 at a dose of 80 mg QD, orally
DRUG	Placebo	Placebo will be administered orally

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2023-09-28
• Last updated: 2026-04-08

Locations

74 sites across 4 countries: United States, Brazil, Canada, Chile

Regulatory

• FDA-regulated drug study