[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630948":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":417,"collaborators":25,"id":419,"slug":25,"hasResults":420,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":420,"sex":426,"minAge":427,"maxAge":428,"enrollmentInfo":429,"targetDuration":25,"studyType":432,"phases":433,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},{"fullName":5,"class":6},"LB Pharmaceuticals Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LB-102","ACTIVE_COMPARATOR","Patients will be randomized 1:1 to either active drug (LB-102) or Placebo. 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 Nomikos",[39,60,73,89,104,117,131,145,155,166,178,192,209,228,242,257,273,287,302,317,332,346,361,376,390,402],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Pillar 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Bear","267-207-2511","ibear@adamsclinical.com",{"facility":362,"status":41,"city":377,"state":378,"zip":379,"country":45,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"DeSoto","Texas","75115",{"type":47,"coordinates":381},[382,383],-96.85695,32.58986,{"lat":383,"lon":382},[386],{"name":387,"role":33,"phone":388,"phoneExt":25,"email":389},"Jaya Koonjbearry","972-283-6286","info@adamsclinical.com",{"facility":40,"status":41,"city":391,"state":378,"zip":392,"country":45,"cosmosGeoPoint":393,"geoPoint":397,"contacts":398},"Richardson","75080",{"type":47,"coordinates":394},[395,396],-96.72972,32.94818,{"lat":396,"lon":395},[399],{"name":400,"role":33,"phone":401,"phoneExt":25,"email":55},"Scott Barley, MD","214-396-4844",{"facility":403,"status":41,"city":404,"state":405,"zip":406,"country":45,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Northwest Clinical Research Center","Bellevue","Washington","98007",{"type":47,"coordinates":408},[409,410],-122.20068,47.61038,{"lat":410,"lon":409},[413],{"name":414,"role":33,"phone":415,"phoneExt":25,"email":416},"Kimberlee Wheeler","425-453-0404","kwheeler@nwcrc.net",{"type":418,"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":430,"type":431},320,"ESTIMATED","INTERVENTIONAL",[434],"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.",[437],"Bipolar I Disorder",[439,440],"Bipolar","Major depression episode","2026-05-07",{"date":443,"type":444},"2026-05-11","ACTUAL",{"date":446,"type":444},"2026-01-23",{"date":448,"type":431},"2028-02",{"name":5,"class":6},26]