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工作效率评估与认知症状的关系(AtWoRC):一项加拿大开放性研究中伏硫西汀治疗重度抑郁症(MDD)患者的主要分析结果。

Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC): primary analysis from a Canadian open-label study of vortioxetine in patients with major depressive disorder (MDD).

机构信息

1Grey Nuns Community Hospital,Edmonton,Alberta,Canada.

2Lundbeck Canada Inc.,Montreal,Quebec,Canada.

出版信息

CNS Spectr. 2019 Jun;24(3):338-347. doi: 10.1017/S1092852918000913. Epub 2018 May 24.

Abstract

OBJECTIVE

The Assessment in Work Productivity and the Relationship with Cognitive Symptoms (AtWoRC) study aimed to assess the association between cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a major depressive episode (MDE).

METHODS

Patients diagnosed with major depressive disorder (MDD) and treated with vortioxetine independently of study enrollment were assessed over 52 weeks at visits that emulated a real-life setting. Patients were classified as those receiving vortioxetine as the first treatment for their current MDE (first treatment) or having shown inadequate response to a previous antidepressant (switch). The primary endpoint was the correlation between changes in patient-reported cognitive symptoms (20-item Perceived Deficits Questionnaire [PDQ-D-20]) and changes in work productivity loss (Work Limitations Questionnaire [WLQ]) at week 12. Additional assessments included changes in symptom and disease severity, cognitive performance, functioning, work loss, and safety.

RESULTS

In the week 12 primary analysis, 196 eligible patients at 26 Canadian sites were enrolled, received at least one treatment dose, and attended at least one postbaseline study visit. This analysis demonstrated a significant, strong correlation between PDQ-D-20 and WLQ productivity loss scores (r=0.634; p<0.001), and this correlation was significant in both first treatment and switch patients (p<0.001). A weaker correlation between Digit Symbol Substitution Test and WLQ scores was found (r=-0.244; p=0.003).

CONCLUSION

At 12 weeks, improvements in cognitive dysfunction were significantly associated with improvements in workplace productivity in patients with MDD, suggesting a role for vortioxetine in functional recovery in MDD.

摘要

目的

评估工作生产力和认知症状之间的关系(AtWoRC)研究旨在评估认知症状与接受文拉法辛治疗的有酬就业患者重度抑郁发作(MDE)之间的关系。

方法

在 52 周的时间内,通过模拟现实环境的就诊,对诊断为重度抑郁症(MDD)且无论是否参与研究均接受文拉法辛治疗的患者进行评估。患者被分类为当前 MDE 的文拉法辛首次治疗(首次治疗)或对先前抗抑郁药反应不足(转换)。主要终点是第 12 周时患者报告的认知症状(20 项感知缺陷问卷 [PDQ-D-20])变化与工作生产力损失(工作限制问卷 [WLQ])变化之间的相关性。其他评估包括症状和疾病严重程度、认知表现、功能、工作损失和安全性的变化。

结果

在第 12 周的主要分析中,26 个加拿大地点的 196 名符合条件的患者入组,接受了至少一剂治疗并参加了至少一次基线后研究访视。这项分析表明,PDQ-D-20 和 WLQ 生产力损失评分之间存在显著、强烈的相关性(r=0.634;p<0.001),并且这种相关性在首次治疗和转换患者中均显著(p<0.001)。发现数字符号替代测试与 WLQ 评分之间存在较弱的相关性(r=-0.244;p=0.003)。

结论

在第 12 周时,认知功能障碍的改善与 MDD 患者工作场所生产力的提高显著相关,表明文拉法辛在 MDD 的功能恢复中发挥作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92ca/6676443/5e49f732ed02/S1092852918000913_fig1.jpg

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