A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)
A Double-Blind, Placebo-Controlled Study of Quetiapine and Paroxetine as Monotherapy in Adults With Bipolar Depression (EMBOLDEN II)
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DOI：
10.4088/jcp.08m04942gre
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发表时间：
2010-02-01
影响因子：
5.3
通讯作者：
Young, Allan H.
中科院分区：
文献类型：
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作者：
McElroy, Susan L.;Weisler, Richard H.;Young, Allan H.
目的：评价奎硫平和帕罗西汀单独治疗双相情感障碍患者的疗效和耐受性。方法：将740例(478例双相1,262例双相11例)患者随机分为奎硫平300 mg/d(n=245)、奎硫平600 mg/d(n=247)、帕罗西汀20 mg/d(n=122)和安慰剂(n=126)，疗程8周。主要终点是蒙哥马利-阿斯伯格抑郁量表(MADRS)总分与基线的变化。结果：8周时奎硫平300 mg、奎硫平600 mg、帕罗西汀-13.76、安慰剂-12.60的平均MADRS评分变化分别为-16.19、-16.31、-13.76和-12.60(P
Objective: The aim of this study was to evaluate the efficacy and tolerability of quetiapine and paroxetine monotherapy for major depression in bipolar disorder.Method: 740 patients (478 bipolar 1, 262 bipolar 11) with major depressive episodes (DSM-IV) were randomly assigned to quetiapine 300 mg/d (n = 245), quetiapine 600 mg/d (n = 247), paroxetine 20 mg/d (n = 122), or placebo (n = 126) for 8 weeks. The primary end point was the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The study was conducted from May 2005 to May 2007.Results: Mean MADRS score change from baseline at 8 weeks was -16.19 for quetiapine 300 mg, -16.31 for quetiapine 600 mg, -13.76 for paroxetine, and -12.60 for placebo (P