Using maintenance electroconvulsive therapy for treatment-resistant schizophrenia
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
This study is testing if adding maintenance electroconvulsive therapy to clozapine can help people with treatment-resistant schizophrenia stay well longer and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Central Institute of Mental Health, Mannheim Academic / other |
| Locations | 14 sites (Aachen and 13 other locations) |
| Trial ID | NCT06456983 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of maintenance electroconvulsive therapy (mECT) combined with clozapine in patients with treatment-resistant schizophrenia. The study will be conducted as a multicenter, blinded, randomized controlled trial, where patients who have shown improvement after an initial series of ECT will be randomized to receive either clozapine alone or clozapine plus mECT. The primary outcome will be the time to relapse, while secondary outcomes will assess improvements in functioning, quality of life, and cognitive performance. The trial seeks to provide robust evidence for the use of mECT in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia who have a history of clozapine-resistant schizophrenia and have shown improvement after an initial ECT series.
Not a fit: Patients with major neurocognitive disorders, severe substance-use disorders, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce relapse rates and improve overall quality of life for patients with treatment-resistant schizophrenia.
How similar studies have performed: Previous studies have indicated the effectiveness of ECT in treatment-resistant schizophrenia, but this specific approach of maintenance ECT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
1. Diagnosis of DSM-5 major neurocognitive disorder ("dementia"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;
2. Inability to read/write German
3. Pregnancy or breast-feeding;
4. General medical condition contraindicating ECT.
Where this trial is running
Aachen and 13 other locations
- Dept. of Psychiatry, RWTU Aachen — Aachen, Germany (Not_yet_recruiting)
- Dept. of Psychiatry, University of Augsburg — Augsburg, Germany (Not_yet_recruiting)
- Klinik für Psychiatrie, Göppingen — Göppingen, Germany (Not_yet_recruiting)
- Departmet of Psychiatry, University Medical Center Göttingen — Göttingen, Germany (Not_yet_recruiting)
- Dept. of Psychiatry, Hannover Medical School — Hanover, Germany (Not_yet_recruiting)
- Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie — Heidelberg, Germany (Not_yet_recruiting)
- Zentrum für Psychische Gesundheit — Ingolstadt, Germany (Not_yet_recruiting)
- Dept. of Psychiatry, University Mainz — Mainz, Germany (Not_yet_recruiting)
- Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH) — Mannheim, Germany (Recruiting)
- Dept. of Psychiatry, LMU München — München, Germany (Not_yet_recruiting)
- Clinic for Psychiatry, Saarbrücken — Saarbrücken, Germany (Not_yet_recruiting)
- Klinik für Psychiatrie, Siegen — Siegen, Germany (Not_yet_recruiting)
- Dept. of Psychiatry, University Tübingen — Tübingen, Germany (Not_yet_recruiting)
- Dept. of Psychiatry I, Wiesloch — Wiesloch, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexander Sartorius, Prof — Central Institute of Mental Health (CIMH), Mannheim, Germany
- Study coordinator: Alexander Sartorius, Prof
- Email: alexander.sartorius@zi-mannheim.de
- Phone: +49-621-1703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.