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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vortioxetine naive | Other | vortioxetine 10 mg 100 patients with Major Depressive Disorder who have not been treated with another antidepressant for the current MDE |
|
| Switch | Other | vortioxetine 10 mg 100 patients with Major Depressive Disorder that require a switch from their current antidepressant due to inadequate response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vortioxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function (PDQ-D-20) | Mean change from baseline in cognitive symptoms as measured by PDQ-D-20. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria do apply.
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| Name | Affiliation | Role |
|---|---|---|
| Pratap Chokka, M.D. | Chokka Center for Integrative Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CA004 | Edmonton | Alberta | T6L 6W6 | Canada | ||
| CA005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30802419 | Derived | Chokka P, Bougie J, Proulx J, Tvistholm AH, Ettrup A. Long-term functioning outcomes are predicted by cognitive symptoms in working patients with major depressive disorder treated with vortioxetine: results from the AtWoRC study. CNS Spectr. 2019 Dec;24(6):616-627. doi: 10.1017/S1092852919000786. |
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|
| 12 and 52 weeks |
| Work productivity (WLQ) | mean change from baseline in work productivity as measured by WLQ. | 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. | 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). | 12 and 52 weeks |
| Work productivity (Sheehan Disability Scale (SDS) | mean change from baseline in work productivity as measured by Sheehan Disability Scale (SDS). | 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). | 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. | 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). | 12 and 52 weeks |
| Kelowna |
| British Columbia |
| V1Y 1Z9 |
| Canada |
| CA006 | St. John's | Newfoundland and Labrador | A1E 2C2 | Canada |
| CA007 | Halifax | Nova Scotia | B3S 1M7 | Canada |
| CA016 | Burlington | Ontario | L7R 4E2 | Canada |
| CA013 | Chatham | Ontario | N7L 1C1 | Canada |
| CA010 | Corunna | Ontario | N0N 1G0 | Canada |
| CA012 | Fort Erie | Ontario | L2A 1Z3 | Canada |
| CA017 | Hamilton | Ontario | L8M 1K7 | Canada |
| CA026 | Hamilton | Ontario | L8N 4A6 | Canada |
| CA011 | London | Ontario | N6H 4P2 | Canada |
| CA003 | Mississauga | Ontario | L5M 4N4 | Canada |
| CA008 | Sarnia | Ontario | N7T 4X3 | Canada |
| CA009 | Sarnia | Ontario | N7T 4X3 | Canada |
| CA015 | St. Catharines | Ontario | L2T 3Y4 | Canada |
| CA022 | Montreal | Quebec | H1N 3V2 | Canada |
| CA020 | Montreal | Quebec | H2R 1V6 | Canada |
| CA023 | Montreal | Quebec | H3A 0G6 | Canada |
| CA018 | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| CA024 | Saint-Jean-sur-Richelieu | Quebec | J2W 1J1 | Canada |
| CA030 | Victoriaville | Quebec | G6P 6P6 | Canada |
| CA027 | Westmount | Quebec | H4A1S9 | Canada |
| CA028 | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| CA019 | Québec | G1G 3Y8 | Canada |
| CA021 | Québec | G3K 2P8 | Canada |
| CA029 | Québec | G3K 2P8 | Canada |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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