[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551199":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":236,"collaborators":12,"id":238,"slug":239,"hasResults":240,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":240,"sex":245,"minAge":246,"maxAge":247,"enrollmentInfo":248,"targetDuration":12,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":156,"whyStopped":12,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"Central Institute of Mental Health, Mannheim","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment as usual (TAU)","NO_INTERVENTION","Patients randomized to TAU only will continue on a stable drug regime for the next 28 weeks, but will not receive maintenance electroconvulsive therapy (mECT)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"maintenance electroconvulsive therapy (mECT) plus TAU","ACTIVE_COMPARATOR","All subjects will enter PHASE 1 and will receive a full course of routine ECT (maximum of 9 weeks and 18 total ECTs with 2-3 treatments per week) while being on stable antipsychotic medication. All ECT-responders (patients with improvement of 30% or more on Brief Psychiatric Rating Scale (BPRS) will enter PHASE 2 and will be randomly assigned to the active comparator (mECT plus treatment-as-usual, TAU) or the control intervention (TAU) which both last 28 weeks. Non-responders (patients without improvement of at least 30 % on BPRS scale) will not enter PHASE 2.",[18],"Device: maintenance electroconvulsive therapy (mECT)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","maintenance electroconvulsive therapy (mECT)","see Arms",[14],[26],{"name":27,"affiliation":28,"role":29},"Alexander Sartorius, Prof","Central Institute of Mental Health (CIMH), Mannheim, Germany","PRINCIPAL_INVESTIGATOR",[31,36],{"name":27,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","+49-621-1703","2913","alexander.sartorius@zi-mannheim.de",{"name":37,"role":32,"phone":38,"phoneExt":39,"email":40},"Christian R Wolf, Prof","+49-6221-56","4405","Christian.Wolf@med.uni-heidelberg.de",[42,61,73,85,97,112,124,139,154,167,179,191,206,221],{"facility":43,"status":44,"city":45,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Dept. of Psychiatry, RWTU Aachen","NOT_YET_RECRUITING","Aachen","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],6.08342,50.77664,{"lat":52,"lon":51},[55,58],{"name":56,"role":32,"phone":12,"phoneExt":12,"email":57},"Thomas Frodl","tfrodl@ukaachen.de",{"name":59,"role":32,"phone":12,"phoneExt":12,"email":60},"Michael Grözinger","mgroezinger@ukaachen.de",{"facility":62,"status":44,"city":63,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Dept. of Psychiatry, University of Augsburg","Augsburg",{"type":49,"coordinates":65},[66,67],10.89851,48.37154,{"lat":67,"lon":66},[70],{"name":71,"role":32,"phone":12,"phoneExt":12,"email":72},"Alkomiet Hasan, Prof.","alkomiet.hasan@med.uni-augsburg.de",{"facility":74,"status":44,"city":75,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Klinik für Psychiatrie, Göppingen","Göppingen",{"type":49,"coordinates":77},[78,79],9.65209,48.70354,{"lat":79,"lon":78},[82],{"name":83,"role":32,"phone":12,"phoneExt":12,"email":84},"Nenad Vasic, Prof.","nenad.vasic@christophsbad.de",{"facility":86,"status":44,"city":87,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Departmet of Psychiatry, University Medical Center Göttingen","Göttingen",{"type":49,"coordinates":89},[90,91],9.93228,51.53443,{"lat":91,"lon":90},[94],{"name":95,"role":32,"phone":12,"phoneExt":12,"email":96},"David Zilles-Wegner","david.zilles@med.uni-goettingen.de",{"facility":98,"status":44,"city":99,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Dept. of Psychiatry, Hannover Medical School","Hanover",{"type":49,"coordinates":101},[102,103],9.73322,52.37052,{"lat":103,"lon":102},[106,109],{"name":107,"role":32,"phone":12,"phoneExt":12,"email":108},"Hannah Maier, Dr.","Maier.Hannah@mh-hannover.de",{"name":110,"role":32,"phone":12,"phoneExt":12,"email":111},"Kai Kahl, Prof.","kahl.kai@mh-hannover.de",{"facility":113,"status":44,"city":114,"state":12,"zip":115,"country":46,"countryCode":47,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie","Heidelberg","69115",{"type":49,"coordinates":117},[118,119],8.69079,49.40768,{"lat":119,"lon":118},[122],{"name":123,"role":32,"phone":12,"phoneExt":12,"email":40},"Christian Wolf",{"facility":125,"status":44,"city":126,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Zentrum für Psychische Gesundheit","Ingolstadt",{"type":49,"coordinates":128},[129,130],11.42372,48.76508,{"lat":130,"lon":129},[133,136],{"name":134,"role":32,"phone":12,"phoneExt":12,"email":135},"Thomas Pollmächer, Prof.","Thomas.Pollmaecher@klinikum-ingolstadt.de",{"name":137,"role":32,"phone":12,"phoneExt":12,"email":138},"Steffen Birkmann, Dr.","Steffen.Birkmann@klinikum-ingolstadt.de",{"facility":140,"status":44,"city":141,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Dept. of Psychiatry, University Mainz","Mainz",{"type":49,"coordinates":143},[144,145],8.28008,49.98185,{"lat":145,"lon":144},[148,151],{"name":149,"role":32,"phone":12,"phoneExt":12,"email":150},"Klaus Lieb, Prof.","Klaus.Lieb@unimedizin-mainz.de",{"name":152,"role":32,"phone":12,"phoneExt":12,"email":153},"Wolfgang Kelsch, Prof.","Wolfgang.Kelsch@unimedizin-mainz.de",{"facility":155,"status":156,"city":157,"state":12,"zip":158,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)","RECRUITING","Mannheim","68159",{"type":49,"coordinates":160},[161,162],8.46694,49.4891,{"lat":162,"lon":161},[165],{"name":166,"role":32,"phone":12,"phoneExt":12,"email":35},"Alexander Sartorius",{"facility":168,"status":44,"city":169,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Dept. of Psychiatry, LMU München","München",{"type":49,"coordinates":171},[172,173],13.31243,51.60698,{"lat":173,"lon":172},[176],{"name":177,"role":32,"phone":12,"phoneExt":12,"email":178},"Oliver Pogarell, Prof.","Oliver.Pogarell@med.uni-muenchen.de",{"facility":180,"status":44,"city":181,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Clinic for Psychiatry, Saarbrücken","Saarbrücken",{"type":49,"coordinates":183},[184,185],7.00982,49.23262,{"lat":185,"lon":184},[188],{"name":189,"role":32,"phone":12,"phoneExt":12,"email":190},"Ulrich Seidl, PD","u.seidl@sb.shg-kliniken.de",{"facility":192,"status":44,"city":193,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Klinik für Psychiatrie, Siegen","Siegen",{"type":49,"coordinates":195},[196,197],8.02431,50.87481,{"lat":197,"lon":196},[200,203],{"name":201,"role":32,"phone":12,"phoneExt":12,"email":202},"Heiko Ullrich, Dr.","h.ullrich@klinikum-siegen.de",{"name":204,"role":32,"phone":12,"phoneExt":12,"email":205},"Peter Plum, Dr.","P.Plum@klinikum-siegen.de",{"facility":207,"status":44,"city":208,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Dept. of Psychiatry, University Tübingen","Tübingen",{"type":49,"coordinates":210},[211,212],9.05222,48.52266,{"lat":212,"lon":211},[215,218],{"name":216,"role":32,"phone":12,"phoneExt":12,"email":217},"Sarah Kayser, Prof.","Sarah.Kayser@med.uni-tuebingen.de",{"name":219,"role":32,"phone":12,"phoneExt":12,"email":220},"Andreas Fallgatter, Prof.","Andreas.Fallgatter@med.uni-tuebingen.de",{"facility":222,"status":44,"city":223,"state":12,"zip":12,"country":46,"countryCode":47,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Dept. of Psychiatry I, Wiesloch","Wiesloch",{"type":49,"coordinates":225},[226,227],8.69846,49.29504,{"lat":227,"lon":226},[230,233],{"name":231,"role":32,"phone":12,"phoneExt":12,"email":232},"Markus Schwarz, Dr.","Markus.Schwarz@PZN-Wiesloch.de",{"name":234,"role":32,"phone":12,"phoneExt":12,"email":235},"Jutta Kammerer-Ciernioch, Dr.","jutta.kammerer@pzn-wiesloch.de",{"type":237,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100551199","maintenance-electroconvulsive-therapy-in-clozapine-resistant-schizophrenia---the-mect-resist-trial-100551199",false,"NCT06456983","Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial","MECT-RESIST","Inclusion Criteria:\n\n* Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), BPRS total score \\> 45 and history of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine;\n\nExclusion Criteria:\n\n1. Diagnosis of DSM-5 major neurocognitive disorder (\"dementia\"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;\n2. Inability to read\u002Fwrite German\n3. Pregnancy or breast-feeding;\n4. General medical condition contraindicating ECT.","ALL","18 Years","75 Years",{"count":249,"type":250},140,"ESTIMATED","INTERVENTIONAL",[253],"NA","Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Hence, a recent Cochrane review stated that the quality of the existing studies is too poor to recommend any intervention in addition to clozapine and that new, randomized controlled trials independent from the pharmaceutical industry need to be performed to substantially improve patient care. Although electroconvulsive therapy (ECT) was initially used to treat schizophrenia, it is nowadays by far underused in the therapy of schizophrenia in many countries. ECT is well known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best. In a multi-center trial the investigators aim to examine the effectiveness of mECT in treatment-resistant patients with schizophrenia who improved after a course of routine ECT. If mECT will lead to a later timepoint of relapse and\u002For to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for \"treatment-resistant\" patients and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.",[256,257],"Schizophrenia","Treatment Resistant Schizophrenia",[259,260],"electroconvulsive therapy","ECT","2026-01-30",{"date":263,"type":264},"2026-02-03","ACTUAL",{"date":266,"type":264},"2025-02-14",{"date":268,"type":250},"2028-07",{"name":5,"class":6},14]