Performance-based cognitive data were collected using the Cognitive Drug Research System in a study of levomilnacipran extended-release (ER) 40-120 mg/day (NCT01034462) in adults with major depressive disorder. These data were analyzed post-hoc to explore the relationship between cognitive measures, depression symptoms (Montgomery-Åsberg Depression Rating Scale, MADRS), and self-reported psychosocial functioning (Sheehan Disability Scale; SDS). Changes from baseline were analyzed in the intent-to-treat population and subgroups with impaired attention, as indicated by baseline Cognitive Drug Research System scores for Power of Attention and Continuity of Attention. Path analyses evaluated the direct and indirect effects of levomilnacipran ER on SDS total score change. Significantly greater improvements were observed for levomilnacipran ER versus placebo for Power of Attention, Continuity of Attention, MADRS, and SDS score changes; the mean differences were larger in the impaired subgroups than in the overall intent-to-treat population. Path analyses showed that the majority of SDS total score improvement (≥50%) was attributable to an indirect treatment effect through MADRS total score change; some direct effect of levomilnacipran ER on SDS total score improvement was also observed. In adults with major depressive disorder, levomilnacipran ER effectively improved measures of depression and cognition, which contributed toward reductions in self-reported functional impairment.

中文翻译：

---

左旋米那普仑缓释对患有认知障碍的重度抑郁症患者的影响：III期研究的事后分析。

使用认知药物研究系统收集了基于表现的认知数据，该研究针对患有严重抑郁症的成年人左旋米那普仑缓释（ER）40-120 mg /天（NCT01034462）。对这些数据进行事后分析，以探讨认知测度，抑郁症状（蒙哥马利-奥斯伯格抑郁量表，MADRS）和自我报告的社会心理功能（Sheehan Disability Scale； SDS）之间的关系。如注意能力和注意连续性的基线认知药物研究系统评分所示，分析了注意力不集中的意向性治疗人群和亚组与基线相比的变化。路径分析评估了左旋米那普仑ER对SDS总分变化的直接和间接影响。与安慰剂相比，左旋米那普仑ER的注意力强度，注意力连续性，MADRS和SDS评分变化明显改善。受损亚组的平均差异要大于总意向治疗人群。路径分析表明，SDS总分改善的大部分（≥50％）归因于MADRS总分改变的间接治疗作用。还观察到左旋米那普仑ER对SDS总评分改善有直接作用。在患有重度抑郁症的成年人中，左旋米那普仑ER有效改善了抑郁和认知的程度，有助于减少自我报告的功能障碍。受损亚组的平均差异要大于总意向治疗人群。路径分析表明，SDS总分改善的大部分（≥50％）归因于MADRS总分改变的间接治疗作用。还观察到左旋米那普仑ER对SDS总评分改善有直接作用。在患有重度抑郁症的成年人中，左旋米那普仑ER可有效改善抑郁和认知能力，从而有助于减少自我报告的功能障碍。受损亚组的平均差异要大于总意向治疗人群。路径分析表明，大多数SDS总分改善（≥50％）归因于MADRS总分改变的间接治疗效果；还观察到左旋米那普仑ER对SDS总评分改善有直接作用。在患有重度抑郁症的成年人中，左旋米那普仑ER有效改善了抑郁和认知的程度，有助于减少自我报告的功能障碍。