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Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial

RecruitingNAAges 18 Years - 75 YearsAllCentral Institute of Mental Health, Mannheim
NCT06456983 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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; Exclusion Criteria: 1. Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder; 2. Inability to read/write German 3. Pregnancy or breast-feeding; 4. General medical condition contraindicating ECT.
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What it tests

  • maintenance electroconvulsive therapy (mECT)
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Where

14 sites
Dept. of Psychiatry, RWTU Aachen
Aachen, Germany
Dept. of Psychiatry, University of Augsburg
Augsburg, Germany
Klinik für Psychiatrie, Göppingen
Göppingen, Germany
Departmet of Psychiatry, University Medical Center Göttingen
Göttingen, Germany
Dept. of Psychiatry, Hannover Medical School
Hanover, Germany
Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie
Heidelberg, Germany
Zentrum für Psychische Gesundheit
Ingolstadt, Germany
Dept. of Psychiatry, University Mainz
Mainz, Germany

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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