Wang Gang, Cheng Yan, Wang Jia Ning, Wu Sheng Hu, Xue Hai Bo
Mood Disorders Center, Beijing Anding Hospital, Capital Medical University, Beijing, People's Republic of China; China Clinical Research Center for Mental Disorders, Beijing, People's Republic of China; Center of Depression, Beijing Institute for Brain Disorders, Beijing, People's Republic of China.
Lilly Suzhou Pharmaceutical Co., Ltd., Shanghai, People's Republic of China.
Neuropsychiatr Dis Treat. 2016 Aug 22;12:2077-87. doi: 10.2147/NDT.S98927. eCollection 2016.
Depression in bipolar I disorder responds to the atypical antipsychotic olanzapine. This subpopulation analysis assessed whether olanzapine is superior to placebo specifically in the treatment of Chinese patients with bipolar I depression.
This was a subpopulation analysis of a 6-week, multicenter, double-blind, parallel, randomized, placebo-controlled trial among 12 Chinese study centers. Eligible inpatients and outpatients were randomized to olanzapine (5 to 20 mg/day) or placebo. Patients were primarily assessed by the Montgomery-Åsberg Depression Rating Scale total score. Secondary assessments used a range of other efficacy and safety measures. This subpopulation analysis was underpowered to show statistically significant differences between treatment groups.
In total, 210 patients (mean age 32.9 years at baseline, 54.3% females) were random-ized. Similar proportions of patients treated with olanzapine (75.0%) and placebo (72.9%) completed the double-blind phase. Baseline-to-endpoint least-squares mean ± standard error decrease in the Montgomery-Åsberg Depression Rating Scale total score in the olanzapine group (-13.55±0.80) was similar to that noted in the parent trial (-13.82±0.65). However, the difference between olanzapine and placebo groups was not statistically significant (P=0.44); this finding was also true for the secondary efficacy measures. A post hoc analysis showed a greater emergence of mania in the placebo group, which likely reduced the treatment difference between olanzapine and placebo in the primary efficacy measure. Safety data were consistent with the known safety profile of olanzapine, including a higher incidence of weight gain (≥7%) in the olanzapine group (24.1% vs 1.4%, P<0.001).
Olanzapine provides similar improvement in depression among Chinese and non-Chinese bipolar I patients. The lack of a statistically significant difference between the olanzapine and placebo groups in this Chinese subpopulation analysis may relate to an a priori lack of study power, and underestimation of the effect of olanzapine because of a greater emergence of mania in placebo-treated patients and missing data associated with a high early discontinuation rate.
双相 I 型障碍中的抑郁对非典型抗精神病药物奥氮平有反应。这项亚组分析评估了奥氮平在治疗中国双相 I 型抑郁患者方面是否优于安慰剂。
这是一项在 12 个中国研究中心进行的为期 6 周的多中心、双盲、平行、随机、安慰剂对照试验的亚组分析。符合条件的住院患者和门诊患者被随机分为奥氮平组（5 至 20 毫克/天）或安慰剂组。主要通过蒙哥马利-Åsberg 抑郁评定量表总分对患者进行评估。次要评估使用了一系列其他疗效和安全性指标。该亚组分析的效能不足以显示治疗组之间具有统计学意义的差异。
总共 210 名患者（基线时平均年龄 32.9 岁，54.3%为女性）被随机分组。接受奥氮平治疗的患者（75.0%）和接受安慰剂治疗的患者（72.9%）完成双盲阶段的比例相似。奥氮平组蒙哥马利-Åsberg 抑郁评定量表总分从基线到终点的最小二乘均值±标准误下降（-13.55±0.80）与母试验中观察到的情况（-13.82±0.65）相似。然而，奥氮平组和安慰剂组之间的差异无统计学意义（P = 0.44）；次要疗效指标的情况也是如此。一项事后分析显示安慰剂组出现躁狂的情况更多，这可能降低了奥氮平与安慰剂在主要疗效指标上的治疗差异。安全性数据与奥氮平已知的安全性特征一致，包括奥氮平组体重增加（≥7%）的发生率更高（24.1%对 1.4%，P < 0.001）。
奥氮平在治疗中国和非中国双相 I 型患者的抑郁方面提供了相似的改善效果。在这项中国亚组分析中，奥氮平组和安慰剂组之间缺乏统计学意义的差异可能与预先缺乏研究效能有关，并且由于安慰剂治疗的患者中躁狂出现更多以及与高早期停药率相关的缺失数据而低估了奥氮平的效果。
