[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510235":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":32,"studyPopulation":32,"armGroups":64,"interventions":76,"overallOfficials":85,"centralContacts":90,"locations":96,"responsibleParty":111,"collaborators":113,"id":120,"slug":32,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":32,"enrollmentInfo":129,"targetDuration":32,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":99,"whyStopped":32,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":46},[9,13,15,18,20,23,24,25],{"measure":10,"description":11,"timeFrame":12},"Change form baseline Depressive Symptom Severity","mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)","after 4 ECT sessions (2 weeks)",{"measure":10,"description":11,"timeFrame":14},"after 8 ECT sessions (4 weeks)",{"measure":16,"description":11,"timeFrame":17},"Depressive Symptom Severity","at the end of acute ECT course (up to 7 weeks)",{"measure":16,"description":11,"timeFrame":19},"3 months post-acute course",{"measure":21,"description":22,"timeFrame":12},"Autobiographical Memory","Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)",{"measure":21,"description":22,"timeFrame":14},{"measure":21,"description":22,"timeFrame":17},{"measure":21,"description":22,"timeFrame":19},[27,30,33,37,40,43],{"measure":28,"description":29,"timeFrame":17},"Response\u002Fremission status","number of participants with an 50 percent decrease in IDS-score\u002F IDS-score \\\u003C 12",{"measure":31,"description":32,"timeFrame":17},"number of ECT treatments needed to achieve response\u002Fremission",null,{"measure":34,"description":35,"timeFrame":36},"Neurocognitive performance (RAVLT)","mean scores on RAVLT (Rey Auditory Verbal Learning Test)","after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course",{"measure":38,"description":39,"timeFrame":36},"Neurocognitive performance (MoCA)","mean scores on MoCA (Montreal Cognitive Assessment)",{"measure":41,"description":42,"timeFrame":36},"Neurocognitive performance (COWAT)","mean scores on COWAT (Controlled Oral Word Association Test)",{"measure":44,"description":45,"timeFrame":36},"Neurocognitive performance (WMS-R)","mean scores on WMS-R (Wechsler Memory Scale) (Cijferreeksen)",[47,50],{"measure":48,"description":49,"timeFrame":36},"Clinical characteristics (CORE)","mean scores on CORE",{"measure":51,"description":52,"timeFrame":36},"Clinical characteristics (PDAS)","mean scores on PDAS",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":32,"timePerspective":32,"maskingInfo":58},"RANDOMIZED","PARALLEL","Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions will be randomized into 2 treatment groups: either continuation with RUL ECT or switch to BT ECT.","TREATMENT",{"masking":59,"maskingDescription":32,"whoMasked":60},"TRIPLE",[61,62,63],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"BT ECT","ACTIVE_COMPARATOR","Participants showing no response will be switched to BT ECT until remission is achieved.",[70],"Device: switch to BT electrode position",{"label":72,"type":67,"description":73,"interventionNames":74},"RUL ECT","Participants showing no response will continue with RUL ECT until remission is achieved.",[75],"Device: continue with RUL electrode position",[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":32},"DEVICE","switch to BT electrode position","use of different electrode positions of ECT device",[66],{"type":78,"name":83,"description":80,"armGroupLabels":84,"otherNames":32},"continue with RUL electrode position",[72],[86],{"name":87,"affiliation":88,"role":89},"Pascal Sienaert, MD, PhD","UPC KU Leuven","PRINCIPAL_INVESTIGATOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":32,"email":95},"Pascal Sienaert, MD,PhD","CONTACT","+322 758 05 11","pascal.sienaert@upckuleuven.be",[97],{"facility":98,"status":99,"city":100,"state":32,"zip":32,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"UPC Kortenberg","RECRUITING","Kortenberg","Belgium","BE",{"type":104,"coordinates":105},"Point",[106,107],4.54353,50.88982,{"lat":107,"lon":106},[110],{"name":87,"role":93,"phone":32,"phoneExt":32,"email":32},{"type":112,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[114,116,118],{"name":115,"class":6},"Universiteit Antwerpen",{"name":117,"class":6},"AZ Sint-Jan AV",{"name":119,"class":6},"General Hospital Groeninge","100510235",false,"NCT05923801","Changing Tactics? Optimizing ECT in Difficult-to-treat Depression","Changing Tactics? Optimizing ECT in Difficult-to-treat Depression: A Randomized Trial Comparing Continuation of Right Unilateral ECT and Switching to Bitemporal ECT in Case of Early Non-response During an Acute Course of ECT for Difficult-to-treat Depression","ChaT","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* Age 18 or older\n* Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84).\n\nExclusion Criteria:\n\n* Contra-indication for general anesthesia\n* Non-Dutch speaking\n* Diagnosis of schizoaffective disorder or schizophrenia\n* Diagnosis of substance use disorder in the past six months\n* Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score \\\u003C23\n* Previous ECT course in the past three months\n* Participation in an interventional Trial with an investigational medicinal product or device\n* Pregnancy","ALL","18 Years",{"count":130,"type":131},196,"ESTIMATED","INTERVENTIONAL",[134],"NA","The goal of this randomized controlled trial is to address which treatment strategy (continue right unilateral (RUL) ECT or switch to bitemporal (BT) ECT speeds up recovery and has the least impact on memory function, in case of early non-response during an acute course of ECT for difficult-to-treat depression.\n\nThe main questions it aims to answer are:\n\n* Assess the antidepressant efficacy and cognitive impact of the continuation of an ongoing treatment with RUL ECT compared to switching the treatment technique to BT ECT, in patients failing to show an early response to an acute course of ECT for major depression;\n* Assess group and subject-specific trajectories of depressive symptom severity and neurocognitive performance during the acute ECT course and up to 3 months post-treatment.\n\nParticipants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions, will be randomized to either switch to BT ECT or continue with RUL ECT. Mood and neurocognitive assessments will be performed at baseline, after 4 ECT sessions (before randomization), after 8 ECT sessions, at the end of the acute course and 3 month after the acute course.",[137],"Depression",[139,137,140],"Electroconvulsive Therapy","Cognition","2026-05-05",{"date":143,"type":144},"2026-05-11","ACTUAL",{"date":146,"type":144},"2023-06-01",{"date":148,"type":131},"2026-06-01",{"name":5,"class":6},1]