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MATRICS 共识认知电池在 29 个地点抗精神病精神分裂症临床试验中的特征。

Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial.

机构信息

Department of Psychiatry, Box 3270, Duke University Medical Center, Durham, NC 27710, USA.

出版信息

Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.

DOI:10.1016/j.schres.2010.09.015
PMID:21075600
Abstract

OBJECTIVE

The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Project produced a battery of tests, the MATRICS Consensus Cognitive Battery (MCCB), designed to assess cognitive treatment effects in clinical trials of patients with schizophrenia. In validation studies, the MCCB demonstrated excellent reliability, minimal practice effects and significant correlations with measures of functional capacity. This study addresses whether the MCCB demonstrates these favorable characteristics when administered in the context of the type of large multi-site industry trial for which it was designed.

METHODS

In a clinical trial comparing risperidone and lurasidone, 323 clinically-stable outpatients with schizophrenia at 29 sites were assessed with MCCB at screening and a median of 15days later at baseline. A measure of functional capacity, the UCSD Performance-based Skills Assessment-Brief (UPSA-B) was administered at baseline.

RESULTS

All 323 (100%) patients had sufficient data for computing a composite score according to the MCCB criteria. The test-retest reliability of the MCCB composite score was excellent (ICC=0.88). The severity of cognitive impairment was T=24.7 (SD=12.1) at screening and T=26.7 (SD=12.4) at baseline. The MCCB composite score demonstrated a large correlation with the UPSA-B composite score (r=.60, df=304, p<.001). The practice effect on the composite score was small (z=0.18).

DISCUSSION

In the context of a 29-site antipsychotic trial in stable outpatients with schizophrenia, the MCCB is sensitive to cognitive deficits in all domains, demonstrates excellent test-retest reliability and small practice effects, and is strongly correlated with a leading measure of functional capacity.

摘要

目的

精神分裂症的测量和治疗研究改善认知 (MATRICS) 项目产生了一系列测试,即 MATRICS 共识认知电池 (MCCB),旨在评估精神分裂症患者临床试验中的认知治疗效果。在验证研究中,MCCB 表现出极好的可靠性、最小的练习效应以及与功能能力测量的显著相关性。本研究探讨了在为其设计的大型多地点行业试验的背景下,MCCB 是否具有这些有利特征。

方法

在一项比较利培酮和鲁拉西酮的临床试验中,29 个地点的 323 名临床稳定的精神分裂症门诊患者在筛选时接受 MCCB 评估,在基线时中位数为 15 天后再次接受评估。一项功能能力测量,即圣地亚哥表现技能评估-简短版 (UPSA-B),在基线时进行。

结果

所有 323 名(100%)患者都有足够的数据根据 MCCB 标准计算综合评分。MCCB 综合评分的测试-重测信度非常好(ICC=0.88)。认知障碍的严重程度在筛选时为 T=24.7(SD=12.1),在基线时为 T=26.7(SD=12.4)。MCCB 综合评分与 UPSA-B 综合评分呈高度相关(r=.60,df=304,p<.001)。综合评分的练习效应较小(z=0.18)。

讨论

在稳定的精神分裂症门诊患者的 29 个地点的抗精神病药物试验中,MCCB 能够敏感地检测到所有领域的认知缺陷,表现出极好的测试-重测信度和较小的练习效应,与主要的功能能力测量密切相关。

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