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Dosing of LB-102 will start at 25 mg QD fixed dose for the first 3 weeks. At the start of Week 4, the dose of LB-102 may be increased to 50 mg QD based on the Clinical Global Impression Scale, Bipolar Version (CGI BP) improvement score.",[13],"Drug: LB-102",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will be randomized 1:1 to either LB-102 or placebo. Those patients on placebo will take one table QD for the length (6 weeks) of the clinical study. Patients will receive a new bottle of medication each week. Patients and PI, study staff will be blinded to which treatment (LB-102 or placebo), patients are randomized to.\n\nPatients will restart antidepressant or mood stabilizer treatment (if applicable) after the last dose of the study treatment on study day 43",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","N-methyl amisulpride",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Inactive substance that looks identical to the active treatment",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Anna Eramo","CONTACT","(212) 605-0300","clinicaltrials@lbpharma.us",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":35},"George 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Koonjbearry","972-283-6286","info@adamsclinical.com",{"facility":40,"status":41,"city":392,"state":379,"zip":393,"country":45,"countryCode":46,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"Richardson","75080",{"type":48,"coordinates":395},[396,397],-96.72972,32.94818,{"lat":397,"lon":396},[400],{"name":401,"role":33,"phone":402,"phoneExt":25,"email":56},"Scott Barley, MD","214-396-4844",{"facility":404,"status":41,"city":405,"state":406,"zip":407,"country":45,"countryCode":46,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"Northwest Clinical Research Center","Bellevue","Washington","98007",{"type":48,"coordinates":409},[410,411],-122.20068,47.61038,{"lat":411,"lon":410},[414],{"name":415,"role":33,"phone":416,"phoneExt":25,"email":417},"Kimberlee Wheeler","425-453-0404","kwheeler@nwcrc.net",{"type":419,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100630948",false,"NCT07494305","Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.","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","Illuminate1","Inclusion Criteria:\n\n* Sign IRB approved ICF, Stable living environment\n* 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\n* Currently experiencing an MDE that began at least 4 weeks but no more than 18 months prior to randomization\n* Currently treated in an out-patient environment\n* MADRS 10 total score ≥24 at both Screening and Baseline with a difference of \\\u003C20% in scores between visits.\n* Clinical Global Impression Scale, Bipolar Version Severity of Illness scale (CGI BP S) depression score ≥4 at both Screening and Baseline.\n* YMRS total score ≤12 at both Screening and Baseline.\n* Good physical health\n* BMI of ≥18 and ≤40 kg\u002Fm2.\n* Eligibility confirmed centrally for the severity, diagnosis, and treatment history by the SAFER interview.\n\nExclusion Criteria:\n\n* 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\n* History of non-response to 2 adequate medication trials for depressive symptoms\n* Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments\n* Have bipolar disorder with mixed features or considered as rapid cyclers\n* Plan to initiate formal cognitive or behavioral therapy, systematic psychotherapy during the study, or plan to initiate such therapy during the study\n* History of disorders other than bipolar disorder, confirmed by previous psychiatric evaluation or the DSM 5 within 12 months prior to Screening\n* Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder.\n* 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.\n* Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment\n* Hypo or hyperthyroidism\n* Insulin dependent diabetes\n* Uncontrolled hypertension\n* Known significant cardiac disease\n* Laboratory results outside the defined protocol ranges\n* Clinically significant abnormal ECG findings\n* Received electroconvulsive therapy (ECT) within 90 days prior to Screening.\n* Received Transcranial Magnetic Stimulation within 90 days prior to Screening\n* Currently taking prohibited medications as defined in the protocol\n* History of non-response and\u002For responded only to ketamine, ECT or vagus nerve stimulation\n* Received GLP-1 within 30 of screening\n* History of organ disease that in the opinion of the PI would not make the patient eligible for participation","ALL","18 Years","65 Years",{"count":431,"type":432},320,"ESTIMATED","INTERVENTIONAL",[435],"PHASE2","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.",[438],"Bipolar I Disorder",[440,441],"Bipolar","Major depression episode","2026-05-07",{"date":444,"type":445},"2026-05-11","ACTUAL",{"date":447,"type":445},"2026-01-23",{"date":449,"type":432},"2028-02",{"name":5,"class":6},26]