RecruitingNot ApplicableNCT06456983

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


Sponsor

Central Institute of Mental Health, Mannheim

Enrollment

140 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • 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 Criteria4

  • Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;
  • Inability to read/write German
  • Pregnancy or breast-feeding;
  • General medical condition contraindicating ECT.

Interventions

DEVICEmaintenance 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

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