NCT06456983 Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
| NCT ID | NCT06456983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Institute of Mental Health, Mannheim |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-02-14 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility 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.
Contact & Investigator
Alexander Sartorius, Prof
PRINCIPAL INVESTIGATOR
Central Institute of Mental Health (CIMH), Mannheim, Germany
Frequently Asked Questions
Who can join the NCT06456983 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06456983 currently recruiting?
Yes, NCT06456983 is actively recruiting participants. Contact the research team at alexander.sartorius@zi-mannheim.de for enrollment information.
Where is the NCT06456983 trial being conducted?
This trial is being conducted at Aachen, Germany, Augsburg, Germany, Göppingen, Germany, Göttingen, Germany and 10 additional locations.
Who is sponsoring the NCT06456983 clinical trial?
NCT06456983 is sponsored by Central Institute of Mental Health, Mannheim. The principal investigator is Alexander Sartorius, Prof at Central Institute of Mental Health (CIMH), Mannheim, Germany. The trial plans to enroll 140 participants.
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