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

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, confirmed by previous psychiatric evaluation or the DSM 5 within 12 months prior to Screening
• •Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder.
• •Hospitalized for mania associated with Bipolar I Disorder within 30 days prior to Screening. Any previous manic phase must have completely resolved before enrollment in the study.
• •Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment
• •Hypo or hyperthyroidism
• •Insulin dependent diabetes
• •Uncontrolled hypertension
• •Known significant cardiac disease
• •Laboratory results outside the defined protocol ranges
• •Clinically significant abnormal ECG findings
• •Received electroconvulsive therapy (ECT) within 90 days prior to Screening.
• •Received Transcranial Magnetic Stimulation within 90 days prior to Screening
• •Currently taking prohibited medications as defined in the protocol
• •History of non-response and/or responded only to ketamine, ECT or vagus nerve stimulation
• •Received GLP-1 within 30 of screening
• •History of organ disease that in the opinion of the PI would not make the patient eligible for participation