← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0-8

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

Headache

Nasopharyngitis

Dry mouth

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out