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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

Summary

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Digit Symbol Substitution Test (DSST)
Secondary study objectives
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
1,406 Total Patients Enrolled
Roger S. McIntyre, MD, FRCPCPrincipal InvestigatorBrain and Cognition Discovery Foundation
Roger S. McIntyre, MDPrincipal InvestigatorBrain and Cognition Discovery Foundation
~49 spots leftby Nov 2025
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