Phase 2 Study to Test Safety and Effectiveness of LB-102 in Adults With Bipolar I Disorder Experiencing Major Depression

What this Trial Is About

Researchers are evaluating the efficacy and safety of LB-102 in treating adult patients with Bipolar I Disorder who are currently experiencing a major depressive episode. This Phase 2, randomized, double-blind, placebo-controlled multicenter study aims to compare the effects of LB-102 against a placebo over a treatment period of six weeks. Participants will be randomly assigned in equal numbers to receive either LB-102 or a placebo once daily by mouth. LB-102 dosing starts at 25 mg daily for the first three weeks, with a possible increase to 50 mg daily from Week 4 based on clinical assessment scores. Patients on placebo will take one tablet daily for six weeks. Medication will be provided in weekly bottles, and both patients and study staff will be unaware of the treatment assignments. After completing the study treatment on Day 43, participants may resume antidepressant or mood stabilizer treatments if applicable. During the study, participants will undergo several assessments including measurement of depressive symptoms using the Montgomery sberg Depression Rating Scale MADRS-10 from baseline to Day 42. Researchers will also monitor adverse events and treatment-emergent mania symptoms using the Young Mania Rating Scale YMRS up to Day 56. The study includes regular visits for medication dispensing and clinical evaluations over the six-week treatment period, with participant health and safety closely observed throughout.

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