Using maintenance electroconvulsive therapy for treatment-resistant schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)
  Mannheim, Germany Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.