Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.
Depression Treatment Center, Beijing Anding Hospital, Capital Medical University, Beijing, China.
J Affect Disord. 2019 Oct 1;257:143-149. doi: 10.1016/j.jad.2019.07.023. Epub 2019 Jul 5.
This study evaluated the non-inferiority of bupropion extended-release (XL) compared to escitalopram for acute-phase treatment of Chinese patients with major depressive disorder (MDD).
This randomized (1:1), double-blind, active-control study conducted between February 2015 and October 2016 included patients with MDD (DSM-IV) (N = 538). The treatment phase had three dose levels (level 1 [Week 1], level 2 [Week 2-4], and level 3 [Week 5-8]), which included either bupropion XL 150 mg, 300 mg, 300 mg or escitalopram 10 mg, 10 mg, 10-20 mg (once-daily), respectively. Primary outcome was mean change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) total score at Week 8.
Overall, 534 patients (bupropion XL, n = 266; escitalopram, n = 268) received at least one dose of study medication. The least square mean (standard error) change from baseline in HAMD-17 total score at Week 8 was -14.5 (0.41) in bupropion XL group and -15.4 (0.39) in escitalopram group (mean difference: 0.8 [-0.27, 1.94]). The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group. Adverse events were reported by 313 patients (bupropion XL, n = 157; escitalopram, n = 156); the most common on-treatment adverse event in both groups was nausea (10.5% versus 18.7%, respectively).
A non-inferiority short-term (8 weeks) study without a placebo arm.
Results from this study demonstrated that the efficacy of bupropion XL was non-inferior to that of escitalopram in Chinese patients with MDD.
本研究评估了安非他酮缓释片（XL）与艾司西酞普兰相比在治疗中国重度抑郁症（MDD）患者急性期的非劣效性。
这是一项于 2015 年 2 月至 2016 年 10 月期间进行的随机（1:1）、双盲、阳性药物对照研究，纳入了 MDD（DSM-IV）患者（N=538）。治疗阶段有三个剂量水平（第 1 级[第 1 周]、第 2 级[第 2-4 周]和第 3 级[第 5-8 周]），分别包括安非他酮 XL 150mg、300mg、300mg 或艾司西酞普兰 10mg、10mg、10-20mg（每日一次）。主要结局是第 8 周时汉密尔顿抑郁量表-17（HAMD-17）总分的基线变化均值。
共有 534 例患者（安非他酮 XL 组，n=266；艾司西酞普兰组，n=268）接受了至少一剂研究药物。安非他酮 XL 组第 8 周时 HAMD-17 总分的最小二乘均值（标准误）从基线的变化为-14.5（0.41），艾司西酞普兰组为-15.4（0.39）（差值：0.8[-0.27，1.94]）。安非他酮 XL 组和艾司西酞普兰组的反应率分别为 69.6%和 72.9%，缓解率分别为 39.7%和 47.2%，持续反应率分别为 51.6%和 56.3%，持续缓解率分别为 25.5%和 28.6%。安非他酮 XL 组和艾司西酞普兰组分别有 313 例（安非他酮 XL 组，n=157；艾司西酞普兰组，n=156）患者报告了不良事件；两组中最常见的治疗期间不良事件为恶心（分别为 10.5%和 18.7%）。
这是一项无安慰剂组的短期（8 周）非劣效性研究。
这项研究的结果表明，在中国 MDD 患者中，安非他酮 XL 的疗效不劣于艾司西酞普兰。
