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Impact of vortioxetine on psychosocial functioning moderated by symptoms of fatigue in post-COVID-19 condition: a secondary analysis

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Abstract

Introduction

Fatigue is a prominent symptom in post-COVID condition (PCC) sequelae, termed “long COVID.” Herein, we aim to ascertain the effect of fatigue on psychosocial function in persons living with PCC.

Methods

This post hoc analysis evaluated the effects of vortioxetine on measures of fatigue as assessed by the Fatigue Severity Scale (FSS) in psychosocial function as measured by the Sheehan Disability Scale (SDS) in persons with PCC. We also evaluated the change in FSS on psychosocial functioning as measured by the Sheehan Disability Scale (SDS). This post hoc analysis obtained data from a recently published placebo-controlled study evaluating vortioxetine’s effect on objective cognitive functions in persons living with PCC.

Results

One hundred forty-four participants meeting World Health Organization (WHO) criteria for PCC were included in this analysis. At the end of 8 weeks of vortioxetine treatment, significant improvement of all domains was observed for psychosocial functioning. There was a significant between-group difference at treatment endpoint in the family, social, and work SDS subcategories (p < 0.001). There was a statistically significant interaction effect between the treatment condition time point and FSS effect on the SDS social (χ2 = 10.640, p = 0.014) and work (χ2 = 9.342, p = 0.025) categories but a statistically insignificant effect on the family categories ((χ2 = 5.201, p = 0.158)).

Discussion

This post hoc analysis suggests that vortioxetine treatment significantly improves psychosocial function in persons with PCC. Our results also indicate that the improvement in psychosocial function was significantly mediated by improvement in measures of fatigue. Our results provide empirical support for recommendations to identify therapeutics for fatigue in persons living with PCC with a broader aim to improve psychosocial function in this common and severely impaired population.

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Authors and Affiliations

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Correspondence to Roger S. McIntyre.

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Ethical approval and consent to participate

This study was conducted in accordance with the principles of Good Clinical Practice (ICH, 1996) and the Declaration of Helsinki (WMA, 2008). A local research ethics board (REB) approved the trial design and all eligible participants provided written informed consent before enrollment. This study was registered on ClinicalTrials.gov (NCT05047952).

Conflict of interest

Dr. Roger S. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute and speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Neurawell, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie and Atai Life Sciences. Dr. S. Roger McIntyre is a CEO of Braxia Scientific Corp.

Kayla M. Teopiz has received fees from Braxia Scientific Corp.

Dr. Joshua D. Rosenblat has received research grant support from the Canadian Institute of Health Research (CIHR), Physician Services Inc. (PSI) Foundation, Labatt Brain Health Network, Brain and Cognition Discovery Foundation (BCDF), Canadian Cancer Society, Canadian Psychiatric Association, Academic Scholars Award, American Psychiatric Association, American Society of Psychopharmacology, University of Toronto, University Health Network Centre for Mental Health, Joseph M. West Family Memorial Fund, and Timeposters Fellowship and industry funding for speaker/consultation/research fees from iGan, Boehringer Ingelheim, Janssen, Allergan, Lundbeck, Sunovion, and COMPASS.

Dr. Rodrigo B. Mansur has received research grant support from the Canadian Institute of Health Research; Physicians’ Services Incorporated Foundation; the Baszucki Brain Research Fund; and the Academic Scholar Awards, Department of Psychiatry, University of Toronto.

All other authors (Sebastian Badulescu, Gia Han Le, Sabrina Wong, Angela T.H. Kwan, Ziji Guo, Lee Phan, and Mehala Subramaniapillai) have no competing interests to declare that are relevant to the content of this article.

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Badulescu, S., Le, G.H., Wong, S. et al. Impact of vortioxetine on psychosocial functioning moderated by symptoms of fatigue in post-COVID-19 condition: a secondary analysis. Neurol Sci 45, 1335–1342 (2024). https://doi.org/10.1007/s10072-024-07377-z

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