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, 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