LB Pharmaceuticals Inc.
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.
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
Inclusion Criteria: * Sign IRB approved ICF, Stable living environment * Diagnosis of Bipolar1 disorder defined by criteria in the DSM 5 and currently experiencing a MDE without psychotic or mixed features, and supported by the SCID 5 CT * Currently experiencing an MDE that began at least 4 weeks but no more than 18 months prior to randomization * Currently treated in an out-patient environment * MADRS 10 total score ≥24 at both Screening and Baseline with a difference of \<20% in scores between visits. * Clinical Global Impression Scale, Bipolar Version Severity of Illness scale (CGI BP S) d…
N-methyl amisulpride
Inactive substance that looks identical to the active treatment