[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554611":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":39,"interventions":50,"overallOfficials":61,"centralContacts":66,"locations":28,"responsibleParty":75,"collaborators":28,"id":79,"slug":28,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":28,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":101,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":28},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Positive And Negative Syndome Scale score","Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms","Baseline, 6 weeks, 12 weeks, 24 weeks",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Change in regional cerebral blood flow by the SPECT-CT brain","Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment","Baseline, 24 weeks",{"measure":19,"description":20,"timeFrame":21},"change in the Monteal Cognitive Assessment scores","change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function","Baseline,6 weeks, 12 weeks, 24 weeks",{"measure":23,"description":24,"timeFrame":12},"change in the Global Assessment of Functioning scores","change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning",{"measure":26,"description":27,"timeFrame":21},"Safety evaluation","Number of events observed in each patient and patients with at least one adverse event",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":35},"TRIPLE",[36,37,38],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[40,45],{"label":41,"type":42,"description":28,"interventionNames":43},"Maintenance ECT","EXPERIMENTAL",[44],"Procedure: maintenance ECT",{"label":46,"type":47,"description":28,"interventionNames":48},"Aripiprazole","ACTIVE_COMPARATOR",[49],"Drug: Aripiprazole tablet",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":28},"PROCEDURE","maintenance ECT","Frequency of weekly sessions for 1 month, then fortnightly for 5 months",[41],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":28},"DRUG","Aripiprazole tablet","Aripiprazole 10 mg in the morning throughout the study period",[46],[62],{"name":63,"affiliation":64,"role":65},"Rituparna Maiti, MD","AIIMS Bhubaneswar","STUDY_DIRECTOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":28,"email":71},"Biswa Ranjan Mishra, MD","CONTACT","9438884220","psych_biswa@aiimsbhubaneswar.edu.in",{"name":73,"role":69,"phone":28,"phoneExt":28,"email":74},"Debadatta Mohapatra, MD","psych_debadatta@aiimsbhubaneswar.edu.in",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","BISWA RANJAN MISHRA","Additional Professor, Psychiatry","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":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96],"Clozapine Resistant Schizophrenia",[98,99,46,100],"Clozapine resistant","schizophrenia","m-ECT","NOT_YET_RECRUITING","2024-07-15",{"date":104,"type":105},"2024-07-16","ACTUAL",{"date":107,"type":90},"2024-08-10",{"date":109,"type":90},"2026-03-31",{"name":5,"class":6}]