Aripiprazole Augmentation in Major Depressive Disorder: A Double-Blind, Placebo-Controlled Study in Patients with Inadequate Response to Antidepressants
Aripiprazole Augmentation in Major Depressive Disorder: A Double-Blind, Placebo-Controlled Study in Patients with Inadequate Response to Antidepressants
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DOI：
10.1017/s1092852900020216
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发表时间：
2009-04-01
期刊：
影响因子：
3.3
通讯作者：
Marcus, Ronald N.
中科院分区：
文献类型：
--
作者：
Berman, Robert M.;Fava, Maurizio;Marcus, Ronald N.
简介：有效管理重性抑郁症（MDD）仍然是精神科医生和初级保健医生的一项具有挑战性的任务。该试验评价了阿立哌唑与抗抑郁药单药治疗MDD患者的疗效和安全性，并独立复制了两项类似试验的阳性结果。研究方法：入组（第0周）有重度抑郁发作和抗抑郁药单药治疗反应不足病史的MDD患者（N= 1，147）; 827例接受单盲安慰剂+开放标签抗抑郁药治疗（艾司西酞普兰、氟西汀、帕罗西汀控释、舍曲林或文拉法辛缓释）持续8周，以确认对抗抑郁药的反应不足; 349例反应不充分的患者随机（1：1）接受双盲、连续安慰剂（n=172）或连续阿立哌唑（n=177; 2-20 mg/天）。主要结果是蒙哥马利-安斯伯格抑郁量表（MADRS）总分从基线（第8周）到终点（第14周）的平均变化。结果：通过（MADRS）总分的下降评估，阿立哌唑治疗组（-10.1）的抑郁症状改善程度高于安慰剂组（-6.4; P < 0.05）。
Introduction: Effective management of major depressive disorder (MDD) continues to be a challenging task for psychiatrists and primary care physicians. This trial evaluated the efficacy and safety of adjunctive aripiprazole versus antidepressant monotherapy in patients with MDD and independently replicated the positive findings of two similar trials.,Methods: Patients (N=1,147) with MDD experiencing a major depressive episode and a history of inadequate response to antidepressant monotherapy were enrolled (week 0); 827 received single-blind adjunctive placebo plus open-label antidepressant (escitalopram, fluoxetine, paroxetine controlled release, sertraline, or venlafaxine extended release) for 8 weeks to confirm inadequate response to antidepressants; 349 patients with inadequate response were randomized (1:1) to double-blind, adjunctive placebo (n=172) or adjunctive aripiprazole (n=177; 2-20 mg/day). Primary outcome was the mean change in Montgomery-angstrom sberg Depression Rating Scale (MADRS) Total score from baseline (week 8) to endpoint (week 14).Results: Clinically significant improvements in depressive symptoms as assessed by decreases in the (MADRS) Total score were greater with adjunctive aripiprazole (-10.1) than placebo (-6.4; P