Efficacy of electroconvulsive therapy augmentation for partial response to clozapine: a pilot randomized ECT – sham controlled trial

Abstract Background Thirty percent of schizophrenia patients are treatment-resistant. Objective This is a single-blinded sham-controlled trial to assess the efficacy of electroconvulsive therapy (ECT) as augmentation strategy in patients with clozapine-resistant schizophrenia. Methods Twenty three subjects were randomly assigned to 12 sessions of ECT (N = 13) or placebo (Sham ECT) (N = 10). The primary outcome was improvement on psychotic symptoms as measured by the mean reduction of the PANSS positive subscale. The assessments were performed by blind raters. Results At baseline both groups were similar, except for negative and total symptoms of the PANSS, which were higher in the Sham group. At the endpoint both groups had a significant decrease from basal score. In the ECT group the PANSS total score decreased 8.78%, from 81.23 to 74.75 (p = 0.042), while the positive subscale had a mean reduction of 19% (19.31 to 16.17, p = 0.006). In the Sham group, the mean reduction of PANSS total score was 15.27% (96.80 to 87.43; p = 0.036), and the PANSS positive subscale decreased 27.81% (22.90 to 19.14, p = 0.008). The CGI score in ECT group decreased 23.0% (5.23 to 4.17; p = 0.001) and decreased 24.31% in the Sham ECT group (5.80 to 4.86; p = 0.004). Discussion In this pilot study, we found no difference between the groups.

摘要 背景：约30%的精神分裂症患者属于治疗抵抗型。
研究目的：本研究为单盲假对照试验，旨在评估电抽搐治疗（electroconvulsive therapy, ECT）作为增效治疗方案，对氯氮平抵抗型精神分裂症患者的临床疗效。
研究方法：共纳入23名受试者，按随机分配原则分为电抽搐治疗组（N=13）与假电抽搐治疗（安慰剂组，N=10），两组均接受12次治疗。本研究的主要结局指标为精神病性症状的改善情况，以阳性和阴性症状量表（Positive and Negative Syndrome Scale, PANSS）阳性因子分的平均降幅作为评估标准，所有评估均由盲法评价者完成。
研究结果：基线状态下，两组除PANSS阴性症状及总症状评分显著高于假治疗组外，其余基线特征无显著差异。治疗结束时，两组的量表得分均较基线水平出现显著下降。电抽搐治疗组的PANSS总分较基线下降8.78%（从81.23降至74.75，p=0.042），阳性因子分平均降幅达19%（从19.31降至16.17，p=0.006）；假治疗组的PANSS总分平均下降15.27%（从96.80降至87.43，p=0.036），阳性因子分下降27.81%（从22.90降至19.14，p=0.008）。电抽搐治疗组的临床总体印象量表（Clinical Global Impression, CGI）得分下降23.0%（从5.23降至4.17，p=0.001），假治疗组CGI得分下降24.31%（从5.80降至4.86，p=0.004）。
讨论：本先导性研究未观察到两组间存在统计学差异。