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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
~55 spots leftby Jun 2025
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