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Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
Sponsor: Central Institute of Mental Health, Mannheim
Summary
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/or 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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-02-14
Completion Date
2028-07
Last Updated
2026-02-03
Healthy Volunteers
No
Interventions
maintenance electroconvulsive therapy (mECT)
see Arms
Locations (14)
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
Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)
Mannheim, Germany
Dept. of Psychiatry, LMU München
München, Germany
Clinic for Psychiatry, Saarbrücken
Saarbrücken, Germany
Klinik für Psychiatrie, Siegen
Siegen, Germany
Dept. of Psychiatry, University Tübingen
Tübingen, Germany
Dept. of Psychiatry I, Wiesloch
Wiesloch, Germany