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.
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
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
LB Pharmaceuticals Inc.
Lead sponsor