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Antidepressant

Vortioxetine for Cognitive Impairment

Phase 2
Waitlist Available
Led By Roger S. McIntyre, MD, FRCPC
Research Sponsored by Brain and Cognition Discovery Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0-8
Awards & highlights

Study Summary

This trial will test whether vortioxetine, an antidepressant with established pro-cognitive properties, can improve cognitive deficits which develop after an infection consistent with COVID-19.

Eligible Conditions
  • Post-COVID Syndrome
  • Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0-8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0-8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Digit Symbol Substitution Test (DSST)
Secondary outcome measures
Behaviour Inhibition System/Behavioural Activation System (BIS/BAS)
CogState Online Cognitive Battery
Effort-Expenditure for Rewards Task (EEfRT)
+13 more

Side effects data

From 2019 Phase 4 trial • 1106 Patients • NCT02371980
26%
Nausea
8%
Headache
5%
Nasopharyngitis
5%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label: Vortioxetine 10 mg
Double-blind: Placebo
Double-blind: Vortioxetine 5 mg
Double-blind: Vortioxetine 10 mg
Double-blind: Vortioxetine 20 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VortioxetineExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Placebo capsule taken once daily for weeks 0-8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vortioxetine
2015
Completed Phase 4
~8030

Find a Location

Who is running the clinical trial?

Brain and Cognition Discovery FoundationLead Sponsor
7 Previous Clinical Trials
1,095 Total Patients Enrolled
Roger S. McIntyre, MD, FRCPCPrincipal InvestigatorBrain and Cognition Discovery Foundation
Roger S. McIntyre, MDPrincipal InvestigatorBrain and Cognition Discovery Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals above the age of thirty take part in this clinical examination?

"Judging by the listed criteria, this clinical trial is limited to participants between 18 and 65. For younger or older patients respectively, there are 759 and 2730 trials available for them to join."

Answered by AI

What criteria must be met to qualify for participation in this experiment?

"This clinical trial seeks 200 participants, who are between 18 and 65 years of age and experience fatigue. Moreover, the post-COVID-19 condition should be recognized by WHO's 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...'. To guarantee eligibility criteria is met, inclusion will only occur when 12 weeks have elapsed since acute recovery from Covid 19 or if a positive antigen/PCR test result was acquired. In addition to this criterion,"

Answered by AI

How deleterious are the repercussions of taking Vortioxetine?

"Our team at Power gave Vortioxetine a score of 2 due to the existing safety data, though there is yet to be any evidence demonstrating its efficacy in this Phase 2 trial."

Answered by AI

How many participants may take part in this research endeavor?

"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is still underway; it was first posted on September 16th 2021 and modified as recently as July 19th 2022. 200 patients are needed at two distinct facilities."

Answered by AI

Is this medical experiment the inaugural one of its kind?

"Firstly studied in 2016, Vortioxetine was approved for Phase 4 clinical use after the initial trial of 88 patients ran by Takeda. At present, there are 7 ongoing trials across 6 cities and countries testing out this medication."

Answered by AI

Is it currently feasible to enroll in this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that the trial, initiated on September 16th 2021, is currently recruiting patients at two sites with a target of 200 participants overall."

Answered by AI
Recent research and studies
~56 spots leftby Apr 2025