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

中文翻译：

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ECT 与 Sham 治疗耐氯氮平精神分裂症：基于 PANSS-30 单个项目的初步研究的二级分析

大约 60% 的难治性精神分裂症 (TRS) 患者对氯氮平的试验没有反应 [1]。这被称为耐氯氮平的精神分裂症 (CRS)。最近的一项荟萃​​分析表明，氯氮平联合 ECT 对 CRS 有效。然而，作者强调缺乏将 ShamECT 作为对照的研究 [2]。我们进行了一项试点、随机、安慰剂对照、单盲试验，以比较 ECT 作为 CRS（或“超难治性”精神分裂症）患者的增强策略的疗效，与在别处发表的假手术 ECT [3]。简而言之，患者是在圣保罗大学医学院精神分裂症研究项目 (Projesq) 的精神病学研究所招募的。方案（NCT02049021 e 临床试验。gov) 符合赫尔辛基宣言，并获得了圣保罗大学总医院伦理委员会的批准（协议 0364/09）。所有受试者或法定监护人签署知情同意书。包括年龄在 18 至 55 岁之间的男女患者。患者符合 DSM IV-TR 精神分裂症或分裂情感性障碍的诊断标准。使用阳性和阴性综合征量表 (PANSS) [4] 和临床总体印象量表 (CGI) [5] 评估症状和疾病严重程度。患者需要服用氯氮平至少六个月，基线时血浆水平为 350 ng/mL，总 PANSS 60 和 CGI​​ 4。 患者被定义为 CRS（原始出版物中的“超难治性”精神分裂症) 基于 Mouaffak 等人。[6] 修改标准：至少 8 周的氯氮平治疗，血浆氯氮平水平 >350 ng/mL 和中等严重程度的精神病症状 (4) 至少有两到四个 PANSS 和 CGI​​ 阳性症状。ECT组麻醉采用依托咪酯（0.15e0.3mg/kg）或丙泊酚（1e2mg/kg）催眠诱导；琥珀胆碱 (0.5 mg/kg) 用于肌肉松弛，静脉注射阿托品 0.5 mg。假手术组接受相同的麻醉剂，没有肌肉松弛剂或电刺激。ECT 使用双颞电极放置和标准的短暂脉冲刺激阈值滴定和剂量给药。23 名参与者被随机分配到 ECT (n 1⁄4 13) 或假 (n 1⁄4 10) 组。这些组具有相似的基线人口统计学特征、氯氮平血浆水平和精神病理学。只有基线时各组的 PANSS 总分有所不同（ECT 1⁄4 81.23[14.46]；Sham 1⁄4 98.80[19.86] p 1⁄4 0.023）。Sham 组有 3 人辍学，ECT 组有 1 人辍学。使用线性混合效应模型进行组间治疗前和治疗后的比较，以适应辍学 [7] 总 PANSS (p 1⁄4 0.668) 或