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RECRUITING
NCT06456983
NA

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

Sponsor: Central Institute of Mental Health, Mannheim

View on ClinicalTrials.gov

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

DEVICE

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