Efficacy of iloperidone in schizophrenia: A PANSS five-factor analysis

Efficacy of iloperidone in schizophrenia: A PANSS five-factor analysis
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DOI:
10.1016/j.schres.2011.05.018
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发表时间:
2011-09-01
影响因子:
4.5
通讯作者:
Hochfeld, Marla
Hochfeld, Marla
中科院分区:
医学2区
文献类型:
--
作者:
Citrome, Leslie;Meng, Xiangyi;Hochfeld, Marla

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背景:阳性和阴性症状量表(PANSS)总分被广泛用于评估抗精神病药物的疗效,但精神分裂症是一种多维度的疾病。我们进行了五因素分析,以评估伊潘立酮与安慰剂在这些不同领域治疗精神分裂症的疗效。方法:五因素模型是根据 7 项精神分裂症临床试验(4 项安慰剂和活性药物对照试验以及 3 项伊潘立酮非劣效性活性对照试验)的汇总数据确定的(N = 3580)。得出五个因素(兴奋/敌意 [P4、P7、G8、G14]、抑郁/焦虑 [G1、G2、G3、G4、G6]、认知 [P2、N5、N7、G5、G10、G11、G12、G13、G15]、阳性 [P1、P3、P5、P6、C9] 和阴性[N1,N2,N3,N4,N6,G7,G16])来自使用最大方差旋转对 30 个基线 PANSS 项目的协方差矩阵进行因子分析;保留的因子的特征值 >= 0.5。这些新得出的 5 个因素与其他人使用不同数据集发布的其他 5 因素分析仅略有不同。然后应用协方差模型分析来评估伊潘立酮 4-6 周双盲安慰剂和主动对照临床试验的疗效结果。 结果:根据安慰剂对照试验,伊潘立酮较基线的改善(最小二乘均值变化标准误)如下;兴奋/敌意,10-16 mg 为 0.4 +/- 0.21,20-24 mg 为 0.6 +/- 0.43,安慰剂为 -1.0 +/- 0.23;磷
Background: The Positive and Negative Syndrome Scale (PANSS) total score is widely used to assess antipsychotic efficacy, however schizophrenia is a multi-dimensional disorder. We conducted a 5-factor analysis for evaluating the efficacy of iloperidone vs. placebo across these different domains in the treatment of schizophrenia.Method: The 5-factor model was determined from pooled data from 7 clinical trials (4 placebo- and active-controlled and 3 non-inferiority active-comparator trials of iloperidone) in schizophrenia (N = 3580). Five factors were derived (excitement/hostility [P4,P7,G8,G14], depression/anxiety [G1,G2,G3,G4,G6], cognition [P2,N5,N7,G5,G10,G11,G12,G13,G15], positive [P1,P3,P5,P6,C9], and negative [N1,N2,N3,N4,N6,G7,G16]) from a factor analysis on the covariance matrix of 30 baseline PANSS items using a varimax rotation; factors retained had eigenvalues of >= 0.5. These newly derived 5 factors differ only slightly from other 5-factor analyses published by others using different datasets. The analysis of covariance model was then applied to assess these efficacy outcomes from the 4-6 week double-blind placebo and active controlled clinical trials of iloperidone.Results: Based on the placebo-controlled trials, iloperidone improvements from baseline (least squared mean change standard error) were as follows; excitement/hostility, 0.4 +/- 0.21 for 10-16 mg, 0.6 +/- 0.43 for 20-24 mg vs. -1.0 +/- 0.23 for placebo; P