Status:
RECRUITING
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Conditions:
Schizophrenia
Treatment Resistant Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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, includ...
Detailed Description
The scientific aim of the study is to conduct a multicenter, blinded, randomized and actively controlled trial to test the hypothesis that maintenance ECT (mECT) plus clozapine is superior to treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06456983
Start Date
February 14 2025
End Date
July 1 2028
Last Update
February 3 2026
Active Locations (14)
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1
Dept. of Psychiatry, RWTU Aachen
Aachen, Germany
2
Dept. of Psychiatry, University of Augsburg
Augsburg, Germany
3
Klinik für Psychiatrie, Göppingen
Göppingen, Germany
4
Departmet of Psychiatry, University Medical Center Göttingen
Göttingen, Germany