NCT07494305 Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 320 participants in total. It began in 2026-01-23 with a primary completion date of 2028-02.

Brief Summary

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.

Eligibility Criteria

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

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