The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).
This is an interventional, Canadian, multi-site, open-label, single cohort, flexible-dose study. The study will emulate a naturalistic real-life setting. Investigators will include Primary Care Physicians and Psychiatrists working in outpatient clinics. The study will include adult patients diagnosed with MDD according to the DSM-5™. Approximately 200 patients will be enrolled in the study. There will be approximately 100 patients who receive vortioxetine as a first treatment for the current MDE and 100 patients switched to vortioxetine due to inadequate response to their current antidepressant medication treatment. All patients will be treated with vortioxetine as per the product monograph, and at the doses determined appropriate by the investigator. The total study duration from Baseline to the end of follow-up will be approximately 56 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
CA004
Edmonton, Alberta, Canada
CA005
Kelowna, British Columbia, Canada
the association/correlation between changes in patient-reported cognitive symptoms and work productivity. (Perceived Deficit Questionnaire-Depression)
Mean change from Baseline to Week 12 in patient-reported cognitive symptoms as measured by Perceived Deficit Questionnaire-Depression-20 questions (PDQ-D-20) and work productivity as measured by Work Limitations Questionnaire (WLQ) in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).
Time frame: 12 weeks
Cognitive function (PDQ-D-20)
Mean change from baseline in cognitive symptoms as measured by PDQ-D-20.
Time frame: 12 and 52 weeks
Cognitive function (Digit Symbol Substitution Test (DSST)
Mean change from baseline in cognitive symptoms as measured by Digit Symbol Substitution Test (DSST).
Time frame: 12 and 52 weeks
Work productivity (WLQ)
mean change from baseline in work productivity as measured by WLQ.
Time frame: 12 and 52 weeks
Work productivity (Work Productivity and Activity Impairment (WPAI) questionnaire)
mean change from baseline in work productivity as measured by Work Productivity and Activity Impairment (WPAI) questionnaire.
Time frame: 12 and 52 weeks
Work productivity (World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12)
mean change from baseline in work productivity as measured by World Health Organization Disability Assessment Schedule-12 questions (WHODAS-12).
Time frame: 12 and 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CA006
St. John's, Newfoundland and Labrador, Canada
CA007
Halifax, Nova Scotia, Canada
CA016
Burlington, Ontario, Canada
CA013
Chatham, Ontario, Canada
CA010
Corunna, Ontario, Canada
CA012
Fort Erie, Ontario, Canada
CA017
Hamilton, Ontario, Canada
CA026
Hamilton, Ontario, Canada
...and 16 more locations
Work productivity (Sheehan Disability Scale (SDS)
mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS).
Time frame: 12 and 52 weeks
Depressive symptoms (Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR)
mean change from baseline in depressive symptoms as measured by Quick Inventory of Depression Symptomatology-Self Report (QIDS-SR).
Time frame: 12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Improvement (CGI-I) score)
mean change in depressive symptoms as measured by Clinical Global Impression-Improvement (CGI-I) score.
Time frame: 12 and 52 weeks
Depressive symptoms (Clinical Global Impression-Severity (CGI-S)
mean change from baseline in depressive symptoms as measured by Clinical Global Impression-Severity (CGI-S).
Time frame: 12 and 52 weeks