Brain and Cognition Discovery Foundation, Toronto, ON, Canada.
Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Adv Ther. 2024 May;41(5):1983-1994. doi: 10.1007/s12325-024-02826-9. Epub 2024 Mar 23.
To date, there are no therapeutics that have gained regulatory approval by the United States Food and Drug Administration (FDA) for the treatment of post-COVID-19 condition (PCC), a debilitating condition characterized by cognitive impairment and mood symptoms. Additionally, persistent inflammation, metabolic dysfunction, and risks associated with an elevated body mass index (BMI) have been observed. Herein, we aimed to assess the efficacy of vortioxetine in improving depressive symptoms among individuals with PCC, as modulated by inflammation, metabolic dysfunction, and BMI.
In this post-hoc analysis, we present preliminary data obtained from an 8-week randomized, double-blind, placebo-controlled trial. Participants included adults aged 18 years and older residing in Canada who were experiencing symptoms of World Health Organization (WHO)-defined PCC. Recruitment began November 2021 and ended January 2023. Of the 200 participants enrolled, 147 were randomized (1:1) to receive vortioxetine (5-20 mg, n = 73) or placebo (n = 74) for daily treatment under double-blind conditions. The primary outcome measure was the change from baseline to endpoint in the 16-Item Quick Inventory of Depressive Symptomatology Self-Report Questionnaire (QIDS-SR-16).
Our findings revealed significant effects for time (χ = 9.601, p = 0.002), treatment (χ = 9.135, p = 0.003), and the treatment × time × CRP × TG-HDL × BMI interaction (χ = 26.092, p < 0.001) on PCC-related depressive symptoms in the adjusted model. Moreover, the between-group analysis showed a significant improvement with vortioxetine at endpoint as compared to placebo (mean difference = - 5.41, SEM = 1.335, p < 0.001).
Overall, vortioxetine significantly improved depressive symptoms among participants with PCC in the adjusted model. Notably, individuals with baseline markers of increased inflammation, metabolic disruption, and elevated BMI exhibited a more pronounced antidepressant effect at endpoint.
NCT05047952 (ClinicalTrials.gov).
迄今为止，美国食品和药物管理局（FDA）尚未批准任何治疗药物用于治疗新冠后疾病（PCC），这是一种以认知障碍和情绪症状为特征的使人虚弱的疾病。此外，还观察到持续的炎症、代谢功能障碍以及与身体质量指数（BMI）升高相关的风险。在此，我们旨在评估文拉法辛在改善 PCC 患者抑郁症状方面的疗效，同时评估炎症、代谢功能障碍和 BMI 对疗效的调节作用。
这是一项事后分析，我们呈现了一项为期 8 周的随机、双盲、安慰剂对照试验的初步数据。参与者包括居住在加拿大、年龄在 18 岁及以上、出现世界卫生组织（WHO）定义的 PCC 症状的成年人。招募于 2021 年 11 月开始，于 2023 年 1 月结束。在招募的 200 名参与者中，147 名按 1:1 比例随机（双盲）接受文拉法辛（5-20mg，n=73）或安慰剂（n=74）每日治疗。主要结局指标是 16 项贝克抑郁自评量表（QIDS-SR-16）从基线到终点的变化。
在调整后的模型中，时间（χ=9.601，p=0.002）、治疗（χ=9.135，p=0.003）以及治疗×时间×CRP×TG-HDL×BMI 交互作用（χ=26.092，p<0.001）对 PCC 相关抑郁症状均有显著影响。此外，组间分析显示，与安慰剂相比，文拉法辛在终点时显著改善（平均差异=-5.41，SEM=1.335，p<0.001）。
总体而言，文拉法辛在调整后的模型中显著改善了 PCC 患者的抑郁症状。值得注意的是，基线时炎症标志物升高、代谢紊乱和 BMI 升高的个体在终点时表现出更明显的抗抑郁作用。
NCT05047952（ClinicalTrials.gov）。
