Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
NCT Number: NCT06456983
Acronym: MECT-RESIST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Treatment Resistant Schizophrenia
Interventions: DEVICE: maintenance electroconvulsive therapy (mECT)
Sponsor: Central Institute of Mental Health, Mannheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-04
Completion Date: 2028-07
Locations: Dept. of Psychiatry, RWTU Aachen, Aachen, Germany|Dept. of Psychiatry, University of Augsburg, Augsburg, Germany|Klinik für Psychiatrie, Göppingen, Göppingen, Germany|Departmet of Psychiatry, University Medical Center Göttingen, Göttingen, Germany|Dept. of Psychiatry, Hannover Medical School, Hannover, Germany|Universitätsklinikum Heidelberg, Klinik für Allgemeine Psychiatrie, Heidelberg, 69115, Germany|Zentrum für Psychische Gesundheit, Ingolstadt, Germany|Dept. of Psychiatry, University Mainz, Mainz, Germany|Department of Psychiatry and Psychotherapy, Central Institute of Mental Health (CIMH), Mannheim, 68159, Germany|Dept. of Psychiatry, LMU München, München, Germany|Clinic for Psychiatry, Saarbrücken, Saarbrücken, Germany|Klinik für Psychiatrie, Siegen, Siegen, Germany|Dept. of Psychiatry, University Tübingen, Tübingen, Germany|Dept. of Psychiatry I, Wiesloch, Wiesloch, Germany

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.

Primary Outcome Measures: Time to relapse, Time to relapse (relapse defined as BPRS 20 % higher than individual BPRS at start of PHASE 2 at any following study visit OR any unscheduled readmission due to a worsening of psychiatric symptoms OR any unscheduled visit with an BPRS 20 % higher than individual BPRS at start of PHASE 2)., 28 weeks (duration of PHASE 2)
Secondary Outcome Measures: Number of relapse free subjects, Number of relapse free subjects at the end of PHASE 2, after 28 weeks, i.e. end of Phase 2|BPRS, BPRS: Brief Psychiatric Rating scale; higher is worse, after 28 weeks, i.e. end of Phase 2|GAF:, GAF: Global Assessment of Functioning; higher is better, after 28 weeks, i.e. end of Phase 2|SLSSWB:, SLSSWB: self-labeling, stigma stress and well-being (SLSSWB); descriptive subscales, after 28 weeks, i.e. end of Phase 2|PANSS:, PANSS: Positive and Negative Syndrome Scale; higher is worse, after 28 weeks, i.e. end of Phase 2|HAMD:, HAMD: Hamilton Depression scale; higher is worse

SSMIS-SF: Self-Stigma of Mental Illness Scale - Short Form; descriptive subscales, after 28 weeks, i.e. end of Phase 2|NCRS-dv:, NCRS-dv: Northoff catatonia rating scale (German version); higher is worse, after 28 weeks, i.e. end of Phase 2|Q-LES-Q-18:, Q-LES-Q-18: Quality of Life Enjoyment and Satisfaction Questionnaire (for patients with schizophrenia); higher is better, after 28 weeks, i.e. end of Phase 2
Other Outcome Measures: Cognition: MMSE:, MMSE: Mini Mental State Examination; higher is better, after 28 weeks, i.e. end of Phase 2|THINC-it:, THINC-it: Tool for Cognitive Assessment and Measurement; green - amber - red (red means lower than 1 standard deviation worse than healthy control subjects), after 28 weeks, i.e. end of Phase 2