A Phase 4 interventional study of vortioxetine in Major Depressive Disorder, sponsored by Lundbeck Canada Inc.. Completed at 26 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-30.
Sponsored by Lundbeck Canada Inc. · Phase 4, Interventional, and Treatment
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.
111 studies on the registry are indexed under Neurobehavioral Manifestations; 28 are open to participants now.
This study's enrollment of 226 is above the median of 71 across 84 interventional studies indexed under Neurobehavioral Manifestations.
Browse Neurobehavioral Manifestations studies →Lundbeck Canada Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria do apply.
vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE
Drug: vortioxetine
vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response
Drug: vortioxetine
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.
Also known as: Trintellix
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
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
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Neurobehavioral Manifestations→
Lundbeck Canada Inc.