Effect of lurasidone on neurocognitive performance in patients with schizophrenia: A short-term placebo- and active-controlled study followed by a 6-month double-blind extension
Effect of lurasidone on neurocognitive performance in patients with schizophrenia: A short-term placebo- and active-controlled study followed by a 6-month double-blind extension
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DOI：
10.1016/j.euroneuro.2013.08.003
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发表时间：
2013-11-01
影响因子：
5.6
通讯作者：
Loebel, Antony
中科院分区：
文献类型：
--
作者：
Harvey, Philip D.;Siu, Cynthia O.;Loebel, Antony
这项双盲研究评估了接受卢拉西酮和奎硫平XR治疗的精神分裂症患者在为期6周的安慰剂对照研究中认知表现和功能能力的变化，随后进行了6个月的双盲延长。采用COG State计算机化认知成套测验和UPSA-B评定认知能力和功能能力。对所有受试者以及测试分数符合预先规定的有效性标准的子样本进行了分析。在第6周，卢拉西酮(80 mg/天和160 mg/天)组、奎硫平XR组和安慰剂组的综合神经认知评分变化没有统计学意义。对于可评估样本(N=267)，卢拉西酮160 mg在神经认知复合体上优于安慰剂和奎硫平，而卢拉西酮80 mg、奎硫平XR和安慰剂没有差异。所有治疗6周时，UPSA-B评分均优于安慰剂。在双盲扩展研究中，对全样本的分析显示，在3个月和6个月时，卢拉西酮(40-160 mg)组的认知表现明显好于奎硫平XR(200-800 mg)组。认知和UPSA-B总分在基线和随时间变化方面显著相关。这是迄今为止第一项研究性治疗在6周时在认知评估和功能互惠测量方面优于安慰剂的研究，并在6周和6个月的扩展研究治疗中显示出在认知评估上优于积极的参照者。这些发现需要重复，但不是由于实践效果，因为安慰剂和积极的对照。(C)2013爱思唯尔和中国北车保留所有权利。
This double-blind study evaluated change in cognitive performance and functional capacity in lurasidone and quetiapine XR-treated schizophrenia patients over a 6-week, placebo-controlled study, followed by a 6-month, double-blind extension. Cognitive performance and functional capacity were assessed with the Cog State computerized cognitive battery and the UPSA-B. Analyses were conducted for all subjects, as well as the subsample whose test scores met prespecified validity criteria. No statistically significant differences were found for change in the composite neurocognitive score for lurasidone (80 mg/day and 160 mg/day) groups, quetiapine XR and placebo in the full sample at week 6. For the evaluable sample (N=267), lurasidone 160 mg was superior to both placebo and quetiapine on the neurocognitive composite, while lurasidone 80 mg, quetiapine XR, and placebo did not differ. UPSA-B scores were superior to placebo at 6 weeks for all treatments. In the double-blind extension study, analysis of the full sample showed significantly better cognitive performance in the lurasidone (40-160 mg) group compared to the quetiapine XR (200-800 mg) group at both 3 and 6 months. Cognitive and UPSA-B total scores were significantly correlated at baseline and for change over time. This is the first study to date where the investigational treatment was superior to placebo on both cognitive assessments and a functional coprimary measure at 6 weeks, as well as demonstrated superiority to an active comparator on cognitive assessments at 6 weeks and at 6 months of extension study treatment. These findings require replication, but are not due to practice effects, because of the placebo and active controls. (C) 2013 Elsevier B.V. and ECNR All rights reserved.