Real-life Effectiveness of Vortioxetine in Depression

Study Overview
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Brief Summary
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Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

Official Title
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Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vortioxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is ≥18 years The patient is an outpatient, treated in a GP or psychiatric outpatient practice The patient has a diagnosis of major depressive episode according to local diagnostic criteria The patient has been prescribed vortioxetine according to the local Summary of Product Characteristics (SmPC) Exclusion Criteria: The patient is unable to read and understand the information sheet and informed consent form or the Patient Reported Outcomes (PRO) The patient is concurrently participating in a clinical trial The patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria The patient has a diagnosis of bipolar disorder according to local diagnostic criteria The patient has a substance use disorders other than tobacco use disorder The patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning The patient has a mood disorder due to a general medical condition or substances The patient is pregnant, ≤6 months post-partum or breastfeeding The patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients initiating vortioxetine treatment<br>Patients with major depressive disorder initiating treatment with vortioxetine | Drug: Vortioxetine<br>* Treatment with vortioxetine as per local SmPC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Scale (SDS) | A series of patient self-rated, scales designed to measure the extent to which his or her 1) work or school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms | Change since baseline at week 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire - nine items (PHQ-9) | A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression | Change since baseline at week 12 and 24 | 
| Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5) | A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective | Change since baseline at week 12 and 24 |