Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Germany
Dept. of Psychiatry, RWTU Aachen
NOT_YET_RECRUITING
Aachen
Dept. of Psychiatry, University of Augsburg
NOT_YET_RECRUITING
Augsburg
Klinik für Psychiatrie, Göppingen
NOT_YET_RECRUITING
Göppingen
Departmet of Psychiatry, University Medical Center Göttingen
NOT_YET_RECRUITING
Göttingen
Dept. of Psychiatry, Hannover Medical School
NOT_YET_RECRUITING
Hanover
Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie
NOT_YET_RECRUITING
Heidelberg
Zentrum für Psychische Gesundheit
NOT_YET_RECRUITING
Ingolstadt
Dept. of Psychiatry, University Mainz
NOT_YET_RECRUITING
Mainz
Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH)
RECRUITING
Mannheim
Dept. of Psychiatry, LMU München
NOT_YET_RECRUITING
München
Clinic for Psychiatry, Saarbrücken
NOT_YET_RECRUITING
Saarbrücken
Klinik für Psychiatrie, Siegen
NOT_YET_RECRUITING
Siegen
Dept. of Psychiatry, University Tübingen
NOT_YET_RECRUITING
Tübingen
Dept. of Psychiatry I, Wiesloch
NOT_YET_RECRUITING
Wiesloch
Contact Information
Primary
Alexander Sartorius, Prof
alexander.sartorius@zi-mannheim.de
+49-621-1703
Backup
Christian R Wolf, Prof
Christian.Wolf@med.uni-heidelberg.de
+49-6221-56
Time Frame
Start Date: 2025-02-14
Estimated Completion Date: 2028-07
Participants
Target number of participants: 140
Treatments
No_intervention: treatment as usual (TAU)
Patients randomized to TAU only will continue on a stable drug regime for the next 28 weeks, but will not receive maintenance electroconvulsive therapy (mECT)
Active_comparator: maintenance electroconvulsive therapy (mECT) plus TAU
All subjects will enter PHASE 1 and will receive a full course of routine ECT (maximum of 6 weeks and 3 treatments per week) while being on stable antipsychotic medication. All ECT-responders (patients with improvement of 30% or more on Brief Psychiatric Rating Scale (BPRS) will enter PHASE 2 and will be randomly assigned to the active comparator (mECT plus treatment-as-usual, TAU) or the control intervention (TAU) which both last 28 weeks. Non-responders (patients without improvement of at least 30 % on BPRS scale) will not enter PHASE 2.
Related Therapeutic Areas
Sponsors
Leads: Central Institute of Mental Health, Mannheim

This content was sourced from clinicaltrials.gov