Kwan Angela T H, Le Gia Han, Guo Ziji, Ceban Felicia, Teopiz Kayla M, Rhee Taeho Greg, Ho Roger, Di Vincenzo Joshua D, Badulescu Sebastian, Meshkat Shakila, Cao Bing, Rosenblat Joshua D, Dev Donovan A, Phan Lee, Subramaniapillai Mehala, McIntyre Roger S
Brain and Cognition Discovery Foundation, 77 Bloor Street West, Suite 617, Toronto, ON, M5S 1M2, Canada.
Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Ann Gen Psychiatry. 2024 Feb 29;23(1):10. doi: 10.1186/s12991-024-00494-1.
Post-COVID-19 Condition (PCC), as defined by the World Health Organization (WHO), currently lacks any regulatory-approved treatments and is characterized by persistent and debilitating cognitive impairment and mood symptoms. Additionally, metabolic dysfunction, chronic inflammation and the associated risks of elevated body mass index (BMI) have been reported. In this study, we aim to investigate the efficacy of vortioxetine in improving cognitive deficits in individuals with PCC, accounting for the interaction of metabolic dysfunction, elevated inflammation and BMI.
This is a post-hoc analysis of an 8-week randomized, double-blind, placebo-controlled trial that was conducted among adults aged 18 years and older living in Canada who were experiencing WHO-defined PCC symptoms. The recruitment of participants began in November 2021 and concluded in January 2023. A total of 200 individuals were enrolled, where 147 were randomized in a 1:1 ratio to receive either vortioxetine (5-20 mg, n = 73) or placebo (n = 74) for daily treatment under double-blind conditions. The primary outcome measure was the change in the Digit Symbol Substitution Test (DSST) score from baseline to endpoint.
Our findings showed significant effects for time (χ = 7.771, p = 0.005), treatment (χ = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ = 11.967, p = 0.018) on cognitive function. Moreover, the between-group analysis showed a significant improvement with vortioxetine at endpoint (mean difference = 0.621, SEM = 0.313, p = 0.047).
Overall, vortioxetine demonstrated significant improvements in cognitive deficits among individuals with baseline markers of metabolic dysfunction, elevated inflammation and higher BMI at endpoint as compared to placebo.
NCT05047952 (ClinicalTrials.gov; Registration Date: September 17, 2021).
世界卫生组织（WHO）定义的新冠后状况（PCC）目前缺乏任何经监管批准的治疗方法，其特征为持续且使人衰弱的认知障碍和情绪症状。此外，还报告了代谢功能障碍、慢性炎症以及体重指数（BMI）升高的相关风险。在本研究中，我们旨在研究伏硫西汀改善PCC个体认知缺陷的疗效，同时考虑代谢功能障碍、炎症升高和BMI之间的相互作用。
这是一项对一项为期8周的随机、双盲、安慰剂对照试验的事后分析，该试验在加拿大18岁及以上经历WHO定义的PCC症状的成年人中进行。参与者招募于2021年11月开始，2023年1月结束。共招募了200名个体，其中147名以1:1的比例随机分组，在双盲条件下接受伏硫西汀（5 - 20毫克，n = 73）或安慰剂（n = 74）的每日治疗。主要结局指标是从基线到终点的数字符号替换测验（DSST）分数的变化。
我们的研究结果显示，时间（χ = 7.771，p = 0.005）、治疗（χ = 7.583，p = 0.006）以及治疗×时间×CRP×TG - HDL×BMI相互作用（χ = 11.967，p = 0.018）对认知功能有显著影响。此外，组间分析显示，在终点时伏硫西汀有显著改善（平均差异 = 0.621，标准误 = 0.313，p = 0.047）。
总体而言，与安慰剂相比，伏硫西汀在终点时对具有代谢功能障碍、炎症升高和较高BMI基线标志物的个体的认知缺陷有显著改善。
NCT05047952（ClinicalTrials.gov；注册日期：2021年9月17日）。
