Vortioxetine for Post-COVID-19 Condition

Study Overview

Sponsor: Brain and Cognition Discovery Foundation
Principal Investigator: Roger S. McIntyre, MD, FRCPC
Location: Brain and Cognition Discovery Foundation, Toronto, Ontario, Canada

Objective

To evaluate the effectiveness of Vortioxetine in treating cognitive deficits observed in individuals experiencing post-COVID-19 conditions. The study hypothesizes that vortioxetine will be more effective than a placebo in treating cognitive impairments in affected individuals.

Design

Type: Randomized, double-blinded, placebo-controlled trial
Duration: 8 weeks
Assessment Tool: Digit Symbol Substitution Test (DSST) to measure changes in cognitive functioning from baseline to the end of the trial period.

Participants

Individuals aged 18 and above who have recovered from COVID-19 but continue to experience cognitive deficits and other symptoms for more than 2 months. The age groups and respective vortioxetine dosages are as follows:

18-64 years: 10-20 mg of vortioxetine or a placebo
65+ years: 5-10 mg of vortioxetine or a placebo

Detailed Description

Background

A significant percentage of individuals recovering from COVID-19 continue to face distressing symptoms including cognitive impairment, fatigue, and depression, collectively referred to as post-COVID-19 condition. This condition affects daily functioning and can persist, fluctuate, or relapse over time. The World Health Organization (WHO) is working towards establishing a common nomenclature and case definition for this condition.

Rationale

The study is grounded on the pro-cognitive properties of vortioxetine, an antidepressant known to improve cognitive function, motivation, and energy, while reducing fatigue. It also has positive effects on sleep behavior and circadian rhythms. The treatment aims to address the cognitive complaints and deficits which are among the most debilitating features of the post-COVID-19 condition.

Participation Criteria

Inclusion Criteria

Age: 18 and above
Health History: Documented history of SARS-CoV-2 infection
Residency: Must be a resident of Canada
Consent: Ability to provide written informed consent

Exclusion Criteria

Participants will be excluded if they:

Have pre-existing conditions causing cognitive impairment
Are unable to follow study procedures
Have known intolerance to vortioxetine
Are currently on other antidepressants (unless prescribed at subtherapeutic doses for reasons other than mood disorders)
Have a current alcohol or substance use disorder
Are pregnant or breastfeeding
Have received electroconvulsive therapy in the last 6 months

Conclusion

This study spearheaded by the Brain and Cognition Discovery Foundation seeks to find a safe and effective treatment for the post-COVID-19 condition, focusing on alleviating cognitive impairments through the administration of Vortioxetine. It is a step towards addressing the persistent and debilitating symptoms faced by a considerable percentage of COVID-19 recoveries, enhancing their quality of life post-recovery.