[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554611":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":11,"responsibleParty":44,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":11},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maintenance ECT","EXPERIMENTAL",null,[13],"Procedure: maintenance ECT",{"label":15,"type":16,"description":11,"interventionNames":17},"Aripiprazole","ACTIVE_COMPARATOR",[18],"Drug: Aripiprazole tablet",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","maintenance ECT","Frequency of weekly sessions for 1 month, then fortnightly for 5 months",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Aripiprazole tablet","Aripiprazole 10 mg in the morning throughout the study period",[15],[31],{"name":32,"affiliation":33,"role":34},"Rituparna Maiti, MD","AIIMS Bhubaneswar","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Biswa Ranjan Mishra, MD","CONTACT","9438884220","psych_biswa@aiimsbhubaneswar.edu.in",{"name":42,"role":38,"phone":11,"phoneExt":11,"email":43},"Debadatta Mohapatra, MD","psych_debadatta@aiimsbhubaneswar.edu.in",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","BISWA RANJAN MISHRA","Additional Professor, Psychiatry","100554611","phase-4-maintenance-electroconvulsive-therapy-ect-versus-aripiprazole-in-clozapine-resistant-schizophrenia-100554611",false,"NCT06501339","Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia","Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial","Inclusion Criteria:\n\n1. Patients clinically diagnosed with CRS (currently under clozapine)\n2. Patients aged 18-60 years of either sex.\n3. LAR giving voluntary written consent for participation in the study\n\nExclusion Criteria:\n\n1. Patient already on ECT or aripiprazole.\n2. History of psychoactive substance abuse or dependence.\n3. Co-morbid psychiatric, major medical or neurological disorders.\n4. History of organicity or significant head injury.\n5. Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.","ALL","18 Years","60 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.",[66],"Clozapine Resistant Schizophrenia",[68,69,15,70],"Clozapine resistant","schizophrenia","m-ECT","NOT_YET_RECRUITING","2024-07-15",{"date":74,"type":75},"2024-07-16","ACTUAL",{"date":77,"type":60},"2024-08-10",{"date":79,"type":60},"2026-03-31",{"name":5,"class":6}]