Keck Paul E, Calabrese Joseph R, McQuade Robert D, Carson William H, Carlson Berit X, Rollin Linda M, Marcus Ronald N, Sanchez Raymond
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, USA.
J Clin Psychiatry. 2006 Apr;67(4):626-37. doi: 10.4088/jcp.v67n0414.
To investigate the safety and efficacy of aripiprazole in preventing relapse of a mood episode in recently manic- or mixed-episode patients with bipolar I disorder stabilized on aripiprazole.
This randomized, double-blind, parallel-group, placebo-controlled, multicenter study enrolled patients from 76 centers in 3 countries (Argentina, Mexico, United States) from March 2000 to June 2003. Bipolar I disorder (DSM-IV) patients who had recently been hospitalized and treated for a manic or mixed episode entered an open-label stabilization phase (aripiprazole monotherapy: 15 or 30 mg/day, 6-18 weeks). After meeting stabilization criteria (Young Mania Rating Scale score of < or = 10 and Montgomery-Asberg Depression Rating Scale score of < or = 13 for 6 consecutive weeks), 161 patients were randomly assigned to aripiprazole or placebo for the 26-week, double-blind phase. The primary endpoint was time to relapse for a manic, mixed, or depressive episode (defined by discontinuation caused by lack of efficacy).
Aripiprazole was superior to placebo in delaying the time to relapse (p = .020). Aripiprazole-treated patients had significantly fewer relapses (25%) than placebo patients (43%; p = .013). Aripiprazole was superior to placebo in delaying the time to manic relapse (p = .01); however, no significant differences were observed in time to depressive relapse (p = .68). Weight gain (> or = 7% increase) occurred in 7 (13%) aripiprazole-treated and 0 placebo-treated patients. Adverse events (> or = 5% incidence and twice that of placebo) reported by aripiprazole-treated patients were akathisia, pain in the extremities, tremor, and vaginitis.
Aripiprazole, 15 or 30 mg/day, was superior to placebo in maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode who were stabilized and maintained on aripiprazole treatment for 6 weeks, as shown by a longer time to relapse.
探讨阿立哌唑对近期躁狂或混合发作的双相I型障碍患者稳定于阿立哌唑治疗时预防心境发作复发的安全性和有效性。
本随机、双盲、平行组、安慰剂对照、多中心研究于2000年3月至2003年6月从3个国家（阿根廷、墨西哥、美国）的76个中心招募患者。近期因躁狂或混合发作住院治疗的双相I型障碍（DSM-IV）患者进入开放标签稳定期（阿立哌唑单药治疗：15或30mg/天，6 - 18周）。在达到稳定标准（杨氏躁狂评定量表评分≤10且蒙哥马利-阿斯伯格抑郁评定量表评分≤13持续6周）后，161例患者被随机分配至阿立哌唑或安慰剂组进行为期26周的双盲阶段治疗。主要终点为躁狂、混合或抑郁发作的复发时间（定义为由疗效不佳导致的停药）。
在延迟复发时间方面，阿立哌唑优于安慰剂（p = 0.020）。接受阿立哌唑治疗的患者复发率（25%）显著低于安慰剂组患者（43%；p = 0.013）。在延迟躁狂复发时间方面，阿立哌唑优于安慰剂（p = 0.01）；然而，在抑郁复发时间上未观察到显著差异（p = 0.68）。7例（13%）接受阿立哌唑治疗的患者体重增加（增加≥7%），而接受安慰剂治疗的患者无体重增加。接受阿立哌唑治疗的患者报告的不良事件（发生率≥5%且为安慰剂组的两倍）为静坐不能、四肢疼痛、震颤和阴道炎。
对于近期有躁狂或混合发作且稳定于阿立哌唑治疗6周的双相I型障碍患者，每天15或30mg阿立哌唑在维持疗效方面优于安慰剂，表现为复发时间更长。
