NCT07494305

Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: LB Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.

Detailed description

This is a Phase 2, randomized, double blind, placebo controlled, multicenter study designed to assess the efficacy and safety of LB 102 in the treatment of adult patients with major depressive episodes (MDEs) associated with Bipolar I Disorder. Eligible patients will be randomly assigned in a 1:1 ratio to receive LB-102 or placebo as oral administration once daily (QD) treatment for 6 weeks

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	LB-102	N-methyl amisulpride
OTHER	Placebo	Inactive substance that looks identical to the active treatment

Timeline

• Start date: 2026-01-23
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-03-27
• Last updated: 2026-04-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study