Vieta Eduard, T'joen Caroline, McQuade Robert D, Carson William H, Marcus Ronald N, Sanchez Raymond, Owen Randall, Nameche Laurence
Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, Villarroel 170/Rossello 140, 08036 Barcelona, Spain.
Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.
The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium/valproate monotherapy.
This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium/valproate monotherapy (defined as a Young Mania Rating Scale total score >/=16 at the end of phases 1 and 2, with a decrease of </=25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol/liter) or valproate (50-125 mug/ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg/day) or placebo (N=131) for 6 weeks.
Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).
Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.
作者评估了阿立哌唑辅助治疗对锂盐/丙戊酸盐单药治疗部分反应不佳的双相I型躁狂症患者的疗效和安全性。
这项多中心、随机、安慰剂对照研究纳入了正在经历躁狂或混合发作（伴有或不伴有精神病性特征）的门诊患者。对锂盐/丙戊酸盐单药治疗部分反应不佳（定义为在第1和第2阶段结束时杨氏躁狂评定量表总分≥16，且两阶段间降低幅度≤25%）且锂盐目标血清浓度为（0.6 - 1.0 mmol/升）或丙戊酸盐目标血清浓度为（50 - 125 μg/ml）的患者，以2:1的比例随机分配接受阿立哌唑辅助治疗（N = 253；15或30毫克/天）或安慰剂（N = 131），为期6周。
在第6周（主要终点）时，阿立哌唑组（-13.3）的杨氏躁狂评定量表总分较基线的平均改善幅度显著大于安慰剂组（-10.7）。从第1周起，阿立哌唑组与安慰剂组相比，杨氏躁狂评定量表总分有显著改善。此外，从基线到第6周，阿立哌唑组（-1.9）的临床总体印象双相版（CGI - BP）疾病严重程度（躁狂）评分较基线的平均改善幅度显著大于安慰剂组（-1.6）。因不良事件导致停药的发生率，阿立哌唑组高于安慰剂组（分别为9%和5%）。静坐不能是最常报告的锥体外系症状相关不良事件，接受阿立哌唑治疗的患者中发生率（18.6%）显著高于接受安慰剂治疗的患者（5.4%）。从基线到第6周，两组体重变化无显著差异（阿立哌唑组和安慰剂组分别增加0.55千克和0.23千克；采用末次观察结转法）。
阿立哌唑辅助治疗早在第1周就显示出躁狂症状有显著改善，且耐受性与单药治疗研究相似。
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