Angela T H Kwan, Gia Han Le, Ziji Guo, Felicia Ceban, Kayla M Teopiz, Taeho Greg Rhee, Roger Ho, Joshua D Di Vincenzo, Sebastian Badulescu, Shakila Meshkat, Bing Cao, Joshua D Rosenblat, Donovan A Dev, Lee Phan, Mehala Subramaniapillai, Roger S McIntyre
{"title":"代谢紊乱、体重指数和炎症对 COVID-19 后认知功能的影响：关于伏替西汀的随机对照试验。","authors":"Angela T H Kwan, Gia Han Le, Ziji Guo, Felicia Ceban, Kayla M Teopiz, Taeho Greg Rhee, Roger Ho, Joshua D Di Vincenzo, Sebastian Badulescu, Shakila Meshkat, Bing Cao, Joshua D Rosenblat, Donovan A Dev, Lee Phan, Mehala Subramaniapillai, Roger S McIntyre","doi":"10.1186/s12991-024-00494-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Our findings showed significant effects for time (χ<sup>2</sup> = 7.771, p = 0.005), treatment (χ<sup>2</sup> = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ<sup>2</sup> = 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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>NCT05047952 (ClinicalTrials.gov; Registration Date: September 17, 2021).</p>","PeriodicalId":7942,"journal":{"name":"Annals of General Psychiatry","volume":"23 1","pages":"10"},"PeriodicalIF":3.6000,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10905871/pdf/","citationCount":"0","resultStr":"{\"title\":\"Impacts of metabolic disruption, body mass index and inflammation on cognitive function in post-COVID-19 condition: a randomized controlled trial on vortioxetine.\",\"authors\":\"Angela T H Kwan, Gia Han Le, Ziji Guo, Felicia Ceban, Kayla M Teopiz, Taeho Greg Rhee, Roger Ho, Joshua D Di Vincenzo, Sebastian Badulescu, Shakila Meshkat, Bing Cao, Joshua D Rosenblat, Donovan A Dev, Lee Phan, Mehala Subramaniapillai, Roger S McIntyre\",\"doi\":\"10.1186/s12991-024-00494-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Our findings showed significant effects for time (χ<sup>2</sup> = 7.771, p = 0.005), treatment (χ<sup>2</sup> = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ<sup>2</sup> = 11.967, p = 0.018) on cognitive function. 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Impacts of metabolic disruption, body mass index and inflammation on cognitive function in post-COVID-19 condition: a randomized controlled trial on vortioxetine.
Background: 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.
Methods: 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.
Results: Our findings showed significant effects for time (χ2 = 7.771, p = 0.005), treatment (χ2 = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ2 = 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).
Conclusion: 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.
Trial registration: NCT05047952 (ClinicalTrials.gov; Registration Date: September 17, 2021).
期刊介绍：
Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged.
Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.
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