LB-102 for depressive episodes in adults with bipolar I disorder

Trial details

Who runs it

LB Pharmaceuticals Inc.

Trial code

NCT07494305

Record updated

27 July 2026

Original description

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.Read full original descriptionShow less

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder

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.

Inclusion: 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: 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; 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; 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; Received GLP-1 within 30 of screening; History of non-response to 2 adequate medication trials for depressive symptoms; Have bipolar disorder with mixed features or considered as rapid cyclers; Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder; Insulin dependent diabetes; Uncontrolled hypertension; Known significant cardiac disease; History of non-response and/or responded only to ketamine, ECT or vagus nerve stimulation; History of organ disease that in the opinion of the PI would not make the patient eligible for participation; Laboratory results outside the defined protocol ranges; 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; Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments; Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment; Hypo or hyperthyroidism; Clinically significant abnormal ECG findings.

ClinicalTrials.gov NCT07494305