Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456983
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-01-30
Brief Title:
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
Sponsor:
Central Institute of Mental Health Mannheim
Organization:
Central Institute of Mental Health Mannheim
Study Overview
Official Title:
Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MECT-RESIST
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 andor 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
Detailed Description:
The scientific aim of the study is to conduct a multicenter blinded randomized and actively controlled trial to test the hypothesis that maintenance ECT mECT plus clozapine is superior to treatment with clozapine alone in CRS Prior to the start of mECT phase II an acute ECT series phase I should have already led to a significant clinical improvement in CRS patients The superiority of mECT will be proven by a longer time to relapse and secondarily by a lower number of patients with relapse compared to the control group
Secondary objectives are to test the hypotheses that the global level of functioning and quality of life will increase and that depression overall symptoms of the schizophrenic syndrome concomitant catatonic symptoms stress and self-stigmatization will decrease compared to the control group It is also expected that cognitive performance will not only not deteriorate but will improve over the course of the mECT
Once the positive ethics votes have been obtained the first patients will be included at the individual centers following successful center initiation In month 12 at the latest the first patient should leave phase I after 6 weeks as a responder and will be randomized in phase II clozapine versus clozapine plus mECT At month 30 the last patient total n 84 should have been randomized as a responder from phase I and been included in phase II At month 36 the last planned patient completes phase II of the study with hisher last study visit Accordingly heshe is the last patient to start the 12-month follow-up phase In month 46 investigators will start final data evaluation and analysis Investigators will complete the primary publication of the study this time point After 4 years the last patient completes the 12-month follow-up phase At study end final data evaluation and analysis regarding the primary endpoint of the follow-up phase takes place as well as the completion and submission of the primary publication of the follow-up
Secondary objectives are to test the hypotheses that the global level of functioning and quality of life will increase and that depression overall symptoms of the schizophrenic syndrome concomitant catatonic symptoms stress and self-stigmatization will decrease compared to the control group It is also expected that cognitive performance will not only not deteriorate but will improve over the course of the mECT
Once the positive ethics votes have been obtained the first patients will be included at the individual centers following successful center initiation In month 12 at the latest the first patient should leave phase I after 6 weeks as a responder and will be randomized in phase II clozapine versus clozapine plus mECT At month 30 the last patient total n 84 should have been randomized as a responder from phase I and been included in phase II At month 36 the last planned patient completes phase II of the study with hisher last study visit Accordingly heshe is the last patient to start the 12-month follow-up phase In month 46 investigators will start final data evaluation and analysis Investigators will complete the primary publication of the study this time point After 4 years the last patient completes the 12-month follow-up phase At study end final data evaluation and analysis regarding the primary endpoint of the follow-up phase takes place as well as the completion and submission of the primary publication of the follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None