NCT06429722

To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.

A Phase 2a, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With a Major Depressive Episode Associated With Bipolar II Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• 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 pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.

Conditions

• Major Depressive Episode Associated With Bipolar II Disorder

Interventions

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

Timeline

• Start date: 2024-05-13
• Primary completion: 2025-04-09
• Completion: 2025-05-30
• First posted: 2024-05-28
• Last updated: 2026-03-30

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study