A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults.
A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults.
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DOI：
10.1017/s1461145714000546
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发表时间：
2014-10
期刊：
影响因子：
--
通讯作者：
Olsen CK
中科院分区：
文献类型：
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作者：
McIntyre RS;Lophaven S;Olsen CK
评价了沃替西汀10和20 mg/d与安慰剂相比对复发性中重度抑郁症（MDD）成人患者认知功能和抑郁的疗效。在一项双盲多国研究中，患者（18-65岁，N = 602）随机（1：1：1）接受沃替西汀10或20 mg/d或安慰剂治疗8周。认知功能进行了评估与客观的神经心理学测试的执行功能，处理速度，注意力和学习和记忆，以及主观认知措施。主要结局指标为从基线至第8周的复合z评分变化，包括数字符号替代测试（DSST）和Rey听觉语言学习测试（RAVLT）评分。采用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评估抑郁症状。在预定义的主要疗效分析中，两种剂量的沃替西汀均显著优于安慰剂，在复合认知评分上与安慰剂相比的平均治疗差异为0.36（沃替西汀10 mg，p < 0.0001）和0.33（沃替西汀20 mg，p < 0.0001）。与安慰剂相比，沃替西汀在大多数次要目的和患者报告的主观认知测量方面观察到显著改善。第8周时MADRS总分与安慰剂的差异为-4.7（10 mg：p < 0.0001）和-6.7（20 mg：p < 0.0001）。路径和亚组分析表明，沃替西汀对认知的有益作用主要是直接的治疗作用。沃替西汀未出现安全性问题。沃替西汀显著改善了复发性MDD成人患者认知功能的客观和主观指标，这些作用在很大程度上与其改善抑郁症状的作用无关。
The efficacy of vortioxetine 10 and 20 mg/d vs. placebo on cognitive function and depression in adults with recurrent moderate-to-severe major depressive disorder (MDD) was evaluated. Patients (18–65 yr, N = 602) were randomized (1:1:1) to vortioxetine 10 or 20 mg/d or placebo for 8 wk in a double-blind multi-national study. Cognitive function was assessed with objective neuropsychological tests of executive function, processing speed, attention and learning and memory, and a subjective cognitive measure. The primary outcome measure was change from baseline to week 8 in a composite z-score comprising the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test (RAVLT) scores. Depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). In the pre-defined primary efficacy analysis, both doses of vortioxetine were significantly better than placebo, with mean treatment differences vs. placebo of 0.36 (vortioxetine 10 mg, p < 0.0001) and 0.33 (vortioxetine 20 mg, p < 0.0001) on the composite cognition score. Significant improvement vs. placebo was observed for vortioxetine on most of the secondary objectives and subjective patient-reported cognitive measures. The differences to placebo in the MADRS total score at week 8 were −4.7 (10 mg: p < 0.0001) and −6.7 (20 mg: p < 0.0001). Path and subgroup analyses indicate that the beneficial effect of vortioxetine on cognition is largely a direct treatment effect. No safety concern emerged with vortioxetine. Vortioxetine significantly improved objective and subjective measures of cognitive function in adults with recurrent MDD and these effects were largely independent of its effect on improving depressive symptoms.