The authors determined the efficacy and safety of asenapine in preventing recurrence of any mood episode in adults with bipolar I disorder.

Adults with an acute manic or mixed episode per DSM-IV-TR criteria were enrolled in this randomized, placebo-controlled trial consisting of an initial 12- to 16-week open-label period and a 26-week double-blind randomized withdrawal period. The target asenapine dosage was 10 mg b.i.d. in the open-label period but could be titrated down to 5 mg b.i.d. After completing the open-label period, subjects meeting stabilization/stable-responder criteria were randomized to asenapine or placebo treatment in the double-blind period. The primary efficacy endpoint was time to recurrence of any mood event during the double-blind period. Kaplan-Meier estimation was performed, and 95% confidence intervals were determined. Safety was assessed throughout.

A total of 549 subjects entered the open-label period, of whom 253 enrolled in the double-blind randomized withdrawal period (127 in the placebo group; 126 in the asenapine group). Time to recurrence of any mood episode was statistically significantly longer for asenapine- than placebo-treated subjects. In post hoc analyses, significant differences in favor of asenapine over placebo were seen in time to recurrence of manic and depressive episodes. The most common treatment-emergent adverse events were somnolence (10.0%), akathisia (7.7%), and sedation (7.7%) in the open-label period and mania (11.9% of the placebo group compared with 4.0% of the asenapine group) and bipolar I disorder (6.3% compared with 1.6%) in the double-blind period.

Long-term treatment with asenapine was more effective than placebo in preventing recurrence of mood events in adults with bipolar I disorder and was generally well-tolerated.

作者确定了阿塞那平预防双相I型障碍成人任何情绪发作复发的功效和安全性。

符合DSM-IV-TR标准的急性躁狂发作或混合发作的成年人参加了这项随机，安慰剂对照试验，该试验由最初的12到16周开放标签期和26周的双盲随机停药期组成。在开放标签期内，阿塞那平的目标剂量为10 mg bid，但可以滴定至5 mg bid。在完成开放标签期后，将达到稳定/稳定应答标准的受试者随机分为阿塞那平或安慰剂治疗。盲期。主要功效终点是双盲期间任何情绪事件复发的时间。进行了Kaplan-Meier估计，并确定了95％的置信区间。整个过程都对安全性进行了评估。

共有549名受试者进入了开放标签期，其中253名参加了双盲随机停药期（安慰剂组为127名；阿塞那平组为126名）。在统计学上，阿塞那平治疗组受试者的任何情绪发作复发时间均显着长于安慰剂治疗组。在事后分析中，在躁狂和抑郁发作复发时，发现阿塞那平优于安慰剂组存在显着差异。在治疗期间，最常见的治疗不良事件为嗜睡（10.0％），静坐不全（7.7％）和镇静（7.7％）和躁狂症（安慰剂组为11.9％，而阿塞那平组为4.0％ ）和双盲时期的双相性I型障碍（6.3％，而1.6％）。

在双相性I型障碍的成年人中，长期使用阿塞那平治疗比预防安慰剂更有效，可预防情绪事件的复发，并且一般耐受性良好。