A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder
A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder
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DOI：
10.1185/03007995.2012.761600
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发表时间：
2013-03-01
影响因子：
2.3
通讯作者：
Chen, Yinzhong
中科院分区：
文献类型：
--
作者：
Mahableshwarkar, Atul R.;Jacobsen, Paula L.;Chen, Yinzhong
目的：Vortioxetine (Lu AA21004) 是一种在研抗抑郁药。体外研究表明 vortioxetine 是 5-HT3、5-HT7 和 5-HT1D 受体拮抗剂、5-HT1B 受体部分激动剂、5-HT1A 受体激动剂和 5-HT 转运蛋白抑制剂。该试验评估了 2.5 和 5 mg 沃替西汀治疗 MDD 的疗效和耐受性。 研究设计和方法：患有 MDD 的成人 (N = 611) 被随机接受为期 8 周的双盲治疗，使用安慰剂、沃替西汀（2.5 或 5 mg）或活性参考（度洛西汀 60 mg）。主要衡量指标是 24 项汉密尔顿抑郁量表 (HAM-D24) 相对于基线的变化。次要终点包括应答率、临床总体印象量表-总体改善量表（CGI-I）和缓解率。使用亚利桑那性体验（ASEX）量表监测参与者的不良事件（AE）和治疗引起的性功能障碍。结果：与安慰剂相比，两种剂量的沃替西汀均与 HAM-D24 总分下降相关，但不具有统计学意义。第 8 周时，相对于基线的变化为[平均值 (SE)]：-10.50 (0.76) 安慰剂、-12.04 (0.74) 2.5 mg 沃替西汀和 -11.08 (0.74) 5 mg 沃替西汀。沃替西汀组的次要结果指标，包括应答率、CGI-I 和缓解率，与安慰剂组也没有显着差异。度洛西汀治疗与 HAM-D24 总分下降相关 [-13.47(0.75)； p=0.005]以及与安慰剂相比次要结果指标的显着改善（p
Objective:Vortioxetine (Lu AA21004) is an investigational antidepressant. In vitro studies indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter. This trial assessed the efficacy and tolerability of 2.5 and 5 mg vortioxetine for the treatment of MDD.Research design and methods:Adults (N = 611) with MDD were randomized to 8 weeks of double-blind treatment with placebo, vortioxetine (2.5 or 5 mg) or active reference (duloxetine 60 mg). The primary measure was change from baseline in the 24-item Hamilton Depression Scale (HAM-D24). Secondary endpoints included responder rate, Clinical Global Impression Scale-Global Improvement scale (CGI-I), and remission rate. Participants were monitored for adverse events (AEs), and treatment-emergent sexual dysfunction using the Arizona Sexual Experiences (ASEX) scale.Results:Both doses of vortioxetine were associated with declines in HAM-D24 total scores compared to placebo but were not statistically significant. At 8 weeks, changes from baseline were [mean (SE)]: -10.50 (0.76) placebo, -12.04 (0.74) 2.5 mg vortioxetine, and -11.08 (0.74) 5 mg vortioxetine. Secondary outcome measures in the vortioxetine groups, including responder rate, CGI-I, and remission rate, were also not significantly different from placebo. Duloxetine treatment was associated with declines in HAM-D24 total score [-13.47(0.75); p=0.005] as well as significant improvements in secondary outcome measures versus placebo (p