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
Parallel
LB-102
DrugN-methyl amisulpride
Placebo
Other interventionInactive substance that looks identical to the active treatment
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Incidence of Adverse Events
Adverse Events (AEs) will be characterized by type, severity, seriousness, and relationship to treatment. All AEs will be coded using the most up-to-date version of the Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AE is the number and percentage of patients reporting the event at least once during the study, and will be counted only once per system organ class (SOC) and preferred term (PT).
Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score
The Young Mania Rating Scale is a clinical assessment utilized to assess manic symptoms and their severity. The YMRS consists of 11 items, each focusing on a different aspect of mania. The total score can range from 0 to 60 with higher scores indicating more severe manic symptoms.
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