Vortioxetine for Post-COVID-19 Condition

This is an interventional treatment trial for Post-COVID-19 Condition focused on measuring vortioxetine, fatigue, long COVID, post-acute COVID syndrome PASC, long haul COVID, brain fog, cognitive deficit, cognitive dysfunction, COVID-19 sequelae, post-acute COVID-19 syndrome, Trintellix, chronic COVID syndrome, post-COVID-19 condition, long hauler, anti-inflammatory, persistent COVID-19 Read More

Inclusion Criteria

• Age 18+
• Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others* and generally have an impact on everyday functioning. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time.') To ensure the above criteria is met, participants will only be included in the study if they meet all eligibility criteria more than 12 weeks from the onset of their acute Covid-19 symptoms or positive PCR/antigen test.
• Documented history of SARS-CoV-2 infection (positive PCR/antigen test during acute illness OR clinical diagnosis by physician during or after the acute illness).
• Subjective cognitive complaints as detected by the Perceived Deficits Questionnaire (PDQ)-5.
• Ability to provide written informed consent.
• Resident of Canada.

Exclusion Criteria

• Current symptoms are fully explained by major depressive disorder or bipolar disorder.
• Pre-existing conditions that may cause cognitive impairment, or symptoms similar to those seen in post-COVID-19 condition (e.g., major neurocognitive disorder, schizophrenia, chronic fatigue syndrome [CFS]/ encephalitis meningitis [EM]), as assessed by Mini International Neuropsychiatric Interview (MINI) 7.0.2.
• Inability to follow study procedures.
• Known intolerance to vortioxetine and/or prior trial of vortioxetine with demonstrated inefficacy.
• If participants are currently taking other antidepressants, they will be asked to discontinue the antidepressant for 2-4 weeks in order to participate in the study.
• Patients on other antidepressants are allowed to participate only if the antidepressant is prescribed at subtherapeutic doses for a primary indication other than mood disorders. Participants will be made aware in the consent form that the combination of the two antidepressants would be considered investigational and that the safety/efficacy profiles are unknown.
• Current alcohol or substance use disorder.
• Inability to provide consent.
• Current alcohol and/or substance use disorder as confirmed by the M.I.N.I 7.0.2.
• Presence of comorbid psychiatric disorder that is a primary focus of clinical concern as confirmed by the M.I.N.I. 7.0.2.
• Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
• Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function.
• Use of benzodiazepines within 12 hours of cognitive assessments.
• Consumption of alcohol within 8 hours of cognitive assessments.
• Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
• Diagnosed reading disability or dyslexia.
• Clinically significant learning disorder by history.
• Electroconvulsive therapy (ECT) in the last 6 months.
• History of moderate or severe head trauma (e.g., loss of consciousness for >1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
• Pregnant and/or breastfeeding.
• Received investigational agents as part of a separate study within 30 days of the screening visit.
• Actively suicidal/presence of suicidal ideation or evaluated as being at suicide risk (as per clinical judgment).
• Currently receiving treatment with Monoamine Oxidase Inhibitors (MAOIs) antidepressants, antibiotics such as linezolid, or intravenous methylene blue.
• Previous hypersensitivity reaction to vortioxetine or any components of the formulation. Angioedema has been reported in patients treated with vortioxetine.
• Serotonin syndrome.
• Abnormal bleeding.
• Previous history of mania/hypomania.
• Angle closure glaucoma.
• Hyponatremia.
• Moderate hepatic impairment.
• Active seizure disorder/epilepsy, not controlled by medication
• Presence of any unstable medical conditions.