Abstract Details

Title Vortioxetine for the Treatment of Post-COVID-19 Condition: A Randomized Controlled Trial

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) S28 - Vascular and Other Non-Alzheimer’s Dementias (1:00 PM-1:12 PM)

Poster/Presentation
Number 001

Objective

We sought to determine the impact of vortioxetine on cognitive deficits, mood symptoms and health-related quality of life (HRQoL) in persons living with Post-COVID-19 Condition (PCC).

Background Hitherto no therapeutic has received regulatory approval for the treatment of PCC. Cognitive deficits, mood symptoms and significant reduction in HRQoL are highly replicated and debilitating aspects of PCC.

Design/Methods

An 8-week randomized, double-blind, placebo-controlled study of adults ≥ 18 years old residing in Canada with World Health Organization (WHO)-defined PCC symptoms and a history of confirmed SARS-CoV-2 infection was conducted. Recruitment began November 2021 and ended January 2023. Of the 200 participants enrolled, 149 participants were randomized (1:1) to receive vortioxetine (5-20 mg, n = 75) or placebo (n = 74) daily for 8 weeks of double-blind treatment. The primary outcome was the change from baseline-to-endpoint in the Digit Symbol Substitution Test (DSST). Secondary outcomes included changes from baseline-to-endpoint in the Quick Inventory of Depressive Symptomatology-16-item (QIDS-SR16) and World Health Organization Wellbeing Scale-5-item (WHO-5).

Results A total of 68 (90.7%) participants randomized to vortioxetine and 73 (98.6%) participants randomized to placebo completed all 8 weeks. Between-group analysis did not show a significant difference in the overall change in cognitive function (p = 0.361, 95% CI [-0.179, 0.492]). However, in the adjusted model, a significant treatment-by-time interaction was observed in favor of vortioxetine treatment with baseline c-reactive protein (CRP) as a moderator (p = 0.012). Moreover, significant improvement was obtained in measures of depressive symptoms (p < 0.001) and HRQoL (p < 0.001) in vortioxetine-treated participants and between the treatment groups (depressive symptoms: p = 0.026; HRQoL: p = 0.004).

Conclusions Although vortioxetine did not improve cognitive function in the unadjusted model, when adjusting for CRP, a significant pro-cognitive effect was observed; antidepressant effects and improvement in HRQoL in this debilitating disorder were also noted.

Authors/Disclosures
Angela T. Kwan, MSc PRESENTER	Miss Kwan has nothing to disclose.
Lee Phan (Brain and Cognition Discovery Foundation)	Lee Phan has nothing to disclose.
Rodrigo Mansur	No disclosure on file
Joshua Rosenblat	Joshua Rosenblat has nothing to disclose.
Ziji Guo	Ziji Guo has nothing to disclose.
Gia Han Le	No disclosure on file
Kayla Teopiz	Kayla Teopiz has received personal compensation in the range of $10,000-$49,999 for serving as a Contractor with Braxia Scientific Corp. Kayla Teopiz has received personal compensation in the range of $500-$4,999 for serving as a Contractor with Brain and Cognition Discovery Foundation.
Felicia Ceban	Felicia Ceban has nothing to disclose.
Julia Bailey	No disclosure on file
Ranuk Ramachandra	No disclosure on file
Joshua Di Vincenzo (University Health Network)	No disclosure on file
Sebastian Badulescu	Sebastian Badulescu has nothing to disclose.
Pawel Drzadzewski	No disclosure on file
Roger McIntyre	Roger McIntyre has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, Atai Life Sciences. Roger McIntyre has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, Atai Life Sciences. Roger McIntyre has received personal compensation in the range of $5,000-$9,999 for serving as a Research Grant Support with CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute.

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