LAUSR

Approximately 60% of patients with treatment-resistant schizophrenia (TRS) do not respond to a trial of clozapine [1]. This is termed clozapine-resistant schizophrenia (CRS). A recent metanalysis showed that clozapine augmentation with ECT is efficacious for CRS. However, the authors highlighted the lack of studies with ShamECT as a control [2]. We performed a pilot, randomized, placebocontrolled, single-blinded trial to compare the efficacy of ECT as an augmentation strategy in patients with CRS (or “super-refractory” schizophrenia) in comparison to Sham-ECT, published elsewhere [3]. Briefly, patients were recruited at the Institute of Psychiatry of University of S~ ao Paulo Medical School, Schizophrenia Research Program (Projesq). The protocol (NCT02049021 e clinicaltrials. gov) was in accordance to the Helsinki Declaration and was approved by the University of Sao Paulo General Hospital ethics committee (protocol 0364/09). All subjects or a legal guardian signed an informed consent form. Patients of both genders aged between 18 and 55 years were included. Patients met the DSM IV-TR diagnostic criteria for schizophrenia or schizoaffective disorder. The symptom and disease severity were evaluated using the Positive and Negative Syndrome Scale (PANSS) [4] and the Clinical Global Impression scale (CGI) [5]. Patients were required to have been taking clozapine for at least six months with plasma levels 350 ng/ mL at baseline and to have a total PANSS 60 and CGI 4. Patients were defined as having CRS (“super-refractory” schizophrenia in the original publication) based on the Mouaffak et al. [6] modified criteria: at least eight weeks’ of clozapine treatment, plasma clozapine levels of >350 ng/mL and moderate severity of psychotic symptoms ( 4) on at least two to four positive symptoms on the PANSS, as well as the CGI. In the ECT group, anesthesia consisted of hypnotic induction with etomidate (0.15e0.3 mg/kg) or propofol (1e2 mg/kg); suxamethonium (0.5 mg/kg) for muscle relaxation with atropine 0.5 mg intravenously. The Sham group received the same anesthetics without the muscle relaxants or electrical stimulus. ECT was administered with bitemporal electrode placement and standard brief pulse stimulus threshold titration and dosing. Twenty-three participated were randomly assigned to the ECT (n 1⁄4 13) or Sham (n 1⁄4 10) groups. The groups had similar baseline demographics characteristics, clozapine plasma levels, and psychopathology. Only the total PANSS score differed between groups at baseline (ECT 1⁄4 81.23[14.46]; Sham 1⁄4 98.80[19.86] p 1⁄4 0.023). There were three dropouts in the Sham group and one in the ECT group. Preand post-treatment comparisons between groups were carried out with a linear mixed-effects model to accommodate the dropouts [7] There were no statistically significant differences between groups for the total PANSS (p 1⁄4 0.668) or the