Abstract
BackgroundAlthough clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvulsive therapy (ECT) is a highly effective and relatively safe treatment for these clozapine-resistant patients. However, parameters are not yet well specified, such as the optimal number of sessions, their frequency, and the relevance of maintenance ECT. Our objective is to compare the efficacy and tolerance between two protocols of combined ECT and clozapine treatment in patients with ultra-resistant schizophrenia (URS): a 6-month protocol (short protocol with 20 ECT sessions) and a 12-month protocol (long protocol with 40 ECT sessions).MethodsSixty-four patients with schizophrenia with persistent psychotic symptoms despite clozapine treatment will be enrolled in a prospective multicentric assessor-blinded randomized controlled trial. Patients will be randomly assigned to the short or the long protocol. The main outcome is the response rate assessed by the Positive and Negative Symptoms Scale (PANSS) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol. The response was defined as a 30% reduction on the PANSS baseline. Clinical assessments (PANSS, BPRS, HAMD-21, YMRS, CGI, GAF, Modified Overt Aggression Scale (MOAS), and Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)) and plasma clozapine concentration will be performed at baseline and at 2, 4, 6, 9, 12, and 15 months. Neuropsychological measures (MMSE, RL/RI-16, Doors test, D2 Test of Attention, Copy of the Rey-Osterrieth complex figure) will be performed at baseline and at 6 and 15 months.DiscussionThe aims of this research are to optimize protocols of combined ECT with clozapine in patients with URS and to offer specific recommendations for these patients’ care.Trial registrationClinicalTrials.gov NCT03542903. Registered on May 31, 2018. Id RCB: 2017-A02657-46
Highlights
Background and rationale {6a} Treatment-resistant schizophrenia (TRS) is a severe disorder with little to no response to antipsychotic drugs, affecting about 10 to 30% of patients with schizophrenia [1]
The response was defined as a 40% reduction in symptoms based on the psychotic symptom subscale of the Brief Psychiatric Rating Scale (BPRS), a Clinical Global Impressions (CGI)-severity rating of mild or less, and a CGI improvement rating of much improved
– The response rate assessed by the Brief Psychiatric Rating Scale-18 items (BPRS-18) 3 months after the end of the treatment in patients following the long protocol compared to those following the short protocol
Summary
Background and rationale {6a} Treatment-resistant schizophrenia (TRS) is a severe disorder with little to no response to antipsychotic drugs, affecting about 10 to 30% of patients with schizophrenia [1]. Augmentation of clozapine with ECT is an extremely promising therapeutic strategy for patients suffering from URS, but there is a lack of randomized controlled trials investigating important methodological aspects such as the optimal number and frequency of sessions as well as the need for maintenance ECT It seems that a larger number of ECT sessions is required in patients with TRS than in depression [6], but without real experimental evidence. Advantages and disadvantages of a short versus a long treatment protocol have never been investigated In this context, we designed a prospective randomized controlled trial in order to compare the effects of two different duration protocols of combining ECT with clozapine in URS patients. Our objective is to compare the efficacy and tolerance between two protocols of combined ECT and clozapine treatment in patients with ultra-resistant schizophrenia (URS): a 6-month protocol (short protocol with 20 ECT sessions) and a 12-month protocol (long protocol with 40 ECT sessions)
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