[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LB Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100621325","phase-3-52-week-open-label-safety-tolerability-study-100621325",false,"NCT07369154","52-week Open Label Safety-Tolerability Study","A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia","NOVA3","Inclusion Criteria:\n\n* Provide ICF\n* Patients clinically stable PANSS \\\u003C\u002F= 70 at screening\n* CGI-S \\\u003C\u002F+ 3 at screening\n* Medically stable\n* BMI 18 -40\n* Taking oral antipsychotic treatment for at least 30 days\n* Have stable living environment\n\nExclusion Criteria:\n\n* Sexually active M\u002FF patients not willing to use highly effective contraception\n* Breast feeding\n* History of treatment resistance to schizophrenia medications\n* DSM-5 current diagnosis other than schizophrenia\n* Risk of suicidal behavior\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other","ALL","18 Years","65 Years",{"count":21,"type":22},900,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia",[28],"Schizophrenia","NOT_YET_RECRUITING","2026-05-13",{"date":32,"type":33},"2026-05-15","ACTUAL",{"date":35,"type":22},"2026-04",{"date":37,"type":22},"2029-04",{"name":39,"class":40},"LB Pharmaceuticals Inc.","INDUSTRY",23,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100630948","phase-2-multicenter-study-to-assess-the-efficacy-and-safety-of-lb-102-in-the-treatment-of-adult-patients-with-bp1mde-100630948","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",{"count":51,"type":22},320,[53],"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.",[56],"Bipolar I Disorder",[58,59],"Bipolar","Major depression episode","RECRUITING","2026-05-07",{"date":63,"type":33},"2026-05-11",{"date":65,"type":33},"2026-01-23",{"date":67,"type":22},"2028-02",{"name":39,"class":40},26,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100620896","phase-3-study-to-evaluate-lb-102-for-the-treatment-of-adult-patients-with-acute-schizophrenia-100620896","NCT07363577","Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia","A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia","NOVA2","Inclusion Criteria:\n\n* Able to provide ICF\n* Willing to be hospitalized for duration of the study\n* Diagnosis of schizophrenia as defined by DSM-5\n* BMI - 18-40\n* PANSS 80-120\n\nExclusion Criteria:\n\n* Sexually active m\u002Ff not willing to adhere to highly effect birth control\n* Breast feeding\n* Increase in PANSS of \\> 20% between screening and baseline\n* History of resistant treatment to schizophrenia medications\n* DSM-5 diagnosis other than schizophrenia\n* Risk of suicidal behavior\n* Risk of violent or destructive behavior\n* Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening\n* Score of ≥3 on the BARS global clinical assessment of akathisia at Screening\n* Insulin dependent diabetes\n* Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient",{"count":79,"type":22},456,[25],"This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.",[28],[84,85],"acute schizophrenia,","exacerbated acute schizophrenia","2026-05-05",{"date":88,"type":33},"2026-05-06",{"date":90,"type":33},"2026-03-25",{"date":92,"type":22},"2027-10",{"name":39,"class":40},13,""]