[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645015":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"Watim Medical & Dental College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"lumateperone plus mood stabilizer","EXPERIMENTAL","Lumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode",[13],"Drug: Lumateperone",{"label":15,"type":16,"description":17,"interventionNames":18},"Cariprazine plus mood stabilizer","ACTIVE_COMPARATOR","Cariprazine administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode.",[19],"Drug: Cariprazine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lumateperone","Lumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cariprazine","Cariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Wardha Mazhar Malik, MBBS, Mphil","CONTACT","03315108703","wardhajibran@gmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Wardha Mazhar Malik","Associate Professor Pharmacology","100645015","phase-4-this-study-aims-to-compare-the-efficacy-and-safety-of-lumateperone-and-cariprazine-in-patients-with-bipolar-i-depression-using-montgomery-sberg-depression-rating-scale-madrs-and-clinical-global-impression-bipolar-severity-scale-cgi-bp-s-and-recording-treatment-emergent-adverse-effects-100645015",false,"NCT07676669","This Study Aims to Compare the Efficacy and Safety of Lumateperone and Cariprazine in Patients With Bipolar I Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression Bipolar Severity Scale (CGI-BP-S) and Recording Treatment Emergent Adverse Effects.","Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression","LUCAR-BD","Inclusion Criteria:\n\n* Patients aged 18-60 years\n* Diagnosed with bipolar I depression according to DSM-5 criteria\n* On stable dose of mood stabilizer (lithium or valproate) for at least 2 weeks\n* Moderate to severe depressive symptoms (baseline MADRS score ≥20)\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* • Current manic or mixed episode\n\n  * Rapid cycling bipolar disorder\n  * Substance use disorder\n  * Severe neurological illness or medical emergency\n  * Pregnancy or lactation\n  * Treatment-resistant depression requiring ECT\n  * Active suicidal risk requiring emergency intervention","ALL","18 Years","60 Years",{"count":53,"type":54},140,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","This study aims to compare the efficacy and safety of lumateperone and cariprazine as adjuncts in patients with depression associated with bipolar I using standardized efficacy assessment tools such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression bipolar severity scale (CGI-BP-S) and recording treatment emergent adverse effect.\n\nParticipants will undergo baseline assessment on day 0 using these scales. Follow-up assessments using MADRS and CGI scales will be conducted at Day 15, Day 30 and Day 45. Safety analysis will be performed for all participants who receive at least one dose of study medication. Vitals and treatment-emergent adverse events (TEAEs) will be recorded at every visit",[60],"Bipolar 1 Depression","NOT_YET_RECRUITING","2026-06-23",{"date":64,"type":65},"2026-06-30","ACTUAL",{"date":67,"type":54},"2026-12",{"date":69,"type":54},"2027-08",{"name":5,"class":6}]