Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled, 52-Week Randomized Withdrawal Study
Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled, 52-Week Randomized Withdrawal Study
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DOI：
10.4088/jcp.16m11201
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发表时间：
2017-03-01
影响因子：
5.3
通讯作者：
Carson, William H.
中科院分区：
文献类型：
--
作者：
Calabrese, Joseph R.;Sanchez, Raymond;Carson, William H.
目的：评价长效注射型抗精神病药阿立哌唑400 mg（AOM 400）每月一次作为双相I型障碍（BP-I）维持治疗的疗效、安全性和耐受性。在2012年8月至2016年4月进行的一项双盲、安慰剂对照、52周随机退出研究中，目前正经历躁狂发作的具有DSM-IV-TR诊断的BP-I的患者依次稳定口服阿立哌唑和AOM 400，然后随机分配至AOM 400或安慰剂。主要终点是从随机化到任何情绪发作复发的时间。其他终点包括复发的任何情绪发作和复发的患者比例的情绪发作type.Results：在266例随机患者中，64（48.1%）的133 AOM 400组和38（28.6%）的133安慰剂组完成了研究。与安慰剂相比，AOM 400显著延迟了任何情绪发作复发的时间（风险比：0.45; 95%CI，0.30至0.68; P
Objective: To evaluate efficacy, safety, and tolerability of long-acting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) as maintenance treatment for bipolar I disorder (BP-I).Methods: In a double-blind, placebo-controlled, 52-week randomized withdrawal study conducted from August 2012 to April 2016, patients with a DSM-IV-TR diagnosis of BP-I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then randomized to AOM 400 or placebo. The primary end point was time from randomization to recurrence of any mood episode. Other end points included proportion of patients with recurrence of any mood episode and recurrence by mood episode type.Results: Of 266 randomized patients, 64 (48.1%) of 133 in the AOM 400 group and 38 (28.6%) of 133 in the placebo group completed the study. AOM 400 significantly delayed the time to recurrence of any mood episode compared with placebo (hazard ratio: 0.45; 95% CI, 0.30 to 0.68; P