Vortioxetine for Post-COVID Syndrome

No longer recruiting at 1 trial location

Overseen By Roger S. McIntyre, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brain and Cognition Discovery Foundation

Must not be taking: Antidepressants, Psychostimulants, MAOIs, Benzodiazepines

Disqualifiers: Major depressive disorder, Bipolar, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests vortioxetine, an antidepressant, to determine if it can improve thinking and memory problems in people with long-term symptoms after a COVID-19 infection. The study compares vortioxetine to a placebo (a pill with no active medicine) to evaluate its effectiveness. Individuals who have had COVID-19 and continue to experience cognitive issues for more than two months might be suitable candidates if they live in Canada and have a history of a SARS-CoV-2 infection. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

If you are currently taking other antidepressants, you will need to stop them for 2-4 weeks before joining the study, unless they are prescribed at low doses for reasons other than mood disorders. Other medications that might affect cognitive function may also need to be stopped, as determined by the study investigator.

Is there any evidence suggesting that vortioxetine is likely to be safe for humans?

Research has shown that vortioxetine is usually well-tolerated. Common side effects include nausea, constipation, and vomiting. Some individuals might also experience dizziness or headaches. Serious allergic reactions, such as swelling and hives, have been reported. There is also a risk of increased depression or suicidal thoughts, especially when starting or adjusting the dose.

These side effects are based on past studies with vortioxetine, which is already approved for treating depression. This approval means doctors have some experience with its safety. However, monitoring for any new or worsening symptoms and consulting a healthcare provider if they occur is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Vortioxetine is unique because it offers a new approach to treating post-COVID-19 condition by targeting serotonin receptors in the brain. Unlike traditional treatments that may focus on physical symptoms or mental health aspects separately, Vortioxetine acts as both an antidepressant and a cognitive enhancer, potentially addressing the mental fog and mood disturbances reported by many post-COVID-19 patients. Researchers are excited about its potential to improve both cognitive function and overall mood, providing a comprehensive treatment option for those struggling with long-term effects of COVID-19.

What evidence suggests that vortioxetine might be an effective treatment for post-COVID-19 cognitive deficits?

Research has shown that vortioxetine, one of the treatments in this trial, can improve thinking and memory in people with major depressive disorder (MDD). Studies have found that it not only lifts mood but also helps individuals achieve personal goals and increase productivity at work. Both patients and doctors have observed significant improvements in depression symptoms with vortioxetine. While primarily used for depression, its ability to enhance thinking and memory makes it a promising option for addressing cognitive issues related to post-COVID-19 conditions. Participants in this trial will receive either vortioxetine or a placebo to further evaluate its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Roger S. McIntyre, MD, FRCPC

Principal Investigator

Brain and Cognition Discovery Foundation

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vortioxetine or placebo for 8 weeks to evaluate cognitive deficits in post-COVID-19 condition

8 weeks

Visits may be conducted remotely or in-person

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Vortioxetine

How Is the Trial Designed?

Group I: Vortioxetine Experimental Treatment 1 Intervention

Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8. Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.

Group II: Placebo Placebo Group 1 Intervention

Placebo capsule taken once daily for weeks 0-8.

Who Is Running the Clinical Trial?

Brain and Cognition Discovery Foundation

Lead Sponsor

Trials

8

Recruited

1,600+

Published Research Related to This Trial

In a meta-analysis of 12 trials involving 1508 patients aged 55 and older, vortioxetine (5-20 mg/day) was found to be effective in reducing depression symptoms compared to placebo, particularly at the 20 mg dose, which showed significant improvements in the Montgomery-Åsberg Depression Rating Scale (MADRS).

Vortioxetine was well tolerated, with a similar rate of adverse events (62.3%) compared to placebo (61.5%), and no significant changes in vital signs or other health indicators, making it a safe option for older adults with major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of vortioxetine for the treatment of major depressive disorder in patients aged 55 years or older. Nomikos, GG., Tomori, D., Zhong, W., et al.[2022]

In a study involving 3,263 patients treated with vortioxetine for major depressive disorder in South Korea, the medication demonstrated a favorable safety profile, with only 17.13% reporting any adverse events, most of which were mild.

Vortioxetine was found to be effective, with significant improvements in depression symptoms observed in 1,918 patients after approximately 24 weeks, as indicated by various clinical and patient-reported measures, showing consistent efficacy across different age groups and sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of vortioxetine for major depressive disorder: Real-world evidence from a population-based study in South Korea. Moon, SW., Kim, JW., Kim, DH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8959350/

Effectiveness of Vortioxetine in Patients With Major ... Randomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD).

2. sciencedirect.com sciencedirect.com/science/article/pii/S266691532500085X

Long-term effectiveness of vortioxetine on achievement ... Vortioxetine was found to be effective in helping to achieve personal recovery goals and in enhancing workplace productivity over the 6-month study period in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37105713/

Effectiveness and Safety of Vortioxetine for the Treatment ... Vortioxetine significantly relieved depression symptoms as assessed by both patients (SMD = 2.25, 95% CI = 1.60-2.89) and physicians (SMD = 3.73 ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.977560/full

Effectiveness of vortioxetine for major depressive disorder ... This real-world study demonstrated improvements in functioning, depressive symptoms, and cognitive function in patients with MDD treated with vortioxetine.

5. academic.oup.com academic.oup.com/ijnp/article/26/6/373/7146181

Effectiveness and Safety of Vortioxetine for the Treatment of ... Vortioxetine is effective, well tolerated, and safe for treating MDD in clinical practice, with significant improvements observed in depressive severity, ...

6. trintellixhcp.com trintellixhcp.com/safety-data

Safety Info & Adverse Events | TRINTELLIX (vortioxetine) Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX.

7. us.trintellix.com us.trintellix.com/treatment/side-effects

Possible Side Effects You may experience side effects with TRINTELLIX. The most common side effects in short-term clinical studies were nausea, constipation, and vomiting.

8. mayoclinic.org mayoclinic.org/drugs-supplements/vortioxetine-oral-route/description/drg-20061387

Vortioxetine (oral route) - Side effects & dosage Acid or sour stomach · belching · blurred vision · change in taste · decrease in smell · dizziness or lightheadedness · eye pain · feeling of constant ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12081438/

Comprehensive analysis of adverse events associated with ... In clinical studies, the most common adverse events (AEs) related to vortioxetine include nausea, vomiting, dry mouth, headache, and dizziness ( ...

10. medlineplus.gov medlineplus.gov/druginfo/meds/a614003.html

Vortioxetine: MedlinePlus Drug Information You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, ...