Vortioxetine for Post-COVID-19 Condition

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

149 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests vortioxetine, an antidepressant, to help people aged 18 and older who have thinking and memory problems after recovering from COVID-19. Vortioxetine aims to improve brain function and mood by affecting brain chemicals. The study will compare the effects of vortioxetine over a period of time. Vortioxetine is a new antidepressant designed to target various aspects of brain chemistry.

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.

What data supports the effectiveness of the drug Vortioxetine?

Research shows that Vortioxetine is effective in reducing symptoms of major depressive disorder (MDD). In several studies, patients taking Vortioxetine experienced significant improvements in their depression scores compared to those taking a placebo. ^{1 2 3 4 5}

Is vortioxetine generally safe for humans?

Vortioxetine is generally considered safe for humans, as shown in studies for major depressive disorder and anxiety disorders. However, there have been reports of side effects, such as amenorrhea (absence of menstruation). ^{6 7 8 9 10}

How does the drug vortioxetine differ from other treatments for depression?

Vortioxetine is unique because it works in multiple ways to increase the levels of serotonin, dopamine, and noradrenaline in the brain, which can help improve mood and cognitive function. Unlike some other antidepressants, it has a low risk of causing weight gain or sexual dysfunction, and it does not significantly affect heart rhythm. ^{4 11 12 13 14}

Research Team

Roger S. McIntyre, MD, FRCPC

Principal Investigator

Brain and Cognition Discovery Foundation

Eligibility Criteria

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

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

Treatment Details

Interventions

• Placebo
• Vortioxetine

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vortioxetine 20 mg/day in patients with major depressive disorder: updated analysis of efficacy, safety, and optimal timing of dose adjustment. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of switching therapy to vortioxetine versus other antidepressants in patients with major depressive disorder. [2022]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Relative efficacy and tolerability of vortioxetine versus selected antidepressants by indirect comparisons of similar clinical studies. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A meta-analysis of randomized, placebo-controlled trials of vortioxetine for the treatment of major depressive disorder in adults. [2022]

6. Switzerland 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Vortioxetine-Induced Amenorrhea: A Case Report. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Vortioxetine for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

The efficacy and safety of multiple doses of vortioxetine for generalized anxiety disorder: a meta-analysis. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacology and clinical potential of vortioxetine in the treatment of major depressive disorder. [2021]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Vortioxetine: a review of its use in major depressive disorder. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study. [2022]

14. Germany pubmed.ncbi.nlm.nih.gov

Effects of acute and sustained administration of vortioxetine on the serotonin system in the hippocampus: electrophysiological studies in the rat brain. [2018]