NCT06456983Recruiting
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 30 Jan 2024
- Start date
- 14 Feb 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Diseases
- Schizophrenia
- NCT number
- NCT06456983
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 14 Feb 2025 to the primary completion date, 31 Jul 2027
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;
- General medical condition contraindicating ECT.
Other
- Inability to read/write German
- Pregnancy or breast-feeding;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Psychiatry, RWTU Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Not yet recruiting |
| Dept. of Psychiatry, University of Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Not yet recruiting |
| Klinik für Psychiatrie, Göppingen Coordinator of this site? Confirm its status | Göppingen | Germany | Not yet recruiting |
| Departmet of Psychiatry, University Medical Center Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Not yet recruiting |
| Dept. of Psychiatry, Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Zentrum für Psychische Gesundheit Coordinator of this site? Confirm its status | Ingolstadt | Germany | Not yet recruiting |
| Dept. of Psychiatry, University Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH) Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Dept. of Psychiatry, LMU München Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Clinic for Psychiatry, Saarbrücken Coordinator of this site? Confirm its status | Saarbrücken | Germany | Not yet recruiting |
| Klinik für Psychiatrie, Siegen Coordinator of this site? Confirm its status | Siegen | Germany | Not yet recruiting |
| Dept. of Psychiatry, University Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Not yet recruiting |
| Dept. of Psychiatry I, Wiesloch Coordinator of this site? Confirm its status | Wiesloch | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.