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

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) depression score ≥4 at both Screening and Baseline. * YMRS total score ≤12 at both Screening and Baseline. * Good physical health * BMI of ≥18 and ≤40 kg/m2. * Eligibility confirmed centrally for the severity, diagnosis, and treatment history by the SAFER interview. Exclusion Criteria: * Sexually active woman of childbearing potential and male who are not practicing 2 different methods of birth control or woman who is currently breast feeding * History of non-response to 2 adequate medication trials for depressive symptoms * Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments * Have bipolar disorder with mixed features or considered as rapid cyclers * Plan to initiate formal cognitive or behavioral therapy, systematic psychotherapy during the study, or plan to initiate such therapy during the study * History of disorders other than bipolar disorder…