Real-life Effectiveness of Vortioxetine in Depression (RELIEVE)
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|ClinicalTrials.gov Identifier: NCT03555136|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
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.
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Drug: Vortioxetine|
|Study Type :||Observational|
|Estimated Enrollment :||2100 participants|
|Official Title:||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|
|Actual Study Start Date :||November 17, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Patients initiating vortioxetine treatment
Patients with major depressive disorder initiating treatment with vortioxetine
Treatment with vortioxetine as per local SmPC
- Sheehan Disability Scale (SDS) [ Time Frame: Change since baseline at week 12 and 24 ]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
- The Patient Health Questionnaire - nine items (PHQ-9) [ Time Frame: Change since baseline at week 12 and 24 ]A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression
- Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5) [ Time Frame: Change since baseline at week 12 and 24 ]A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555136
|Contact: Email contact H. Lundbeck A/S||+4536301311||LundbeckClinicalTrials@lundbeck.com|
|United States, Missouri|
|US 0039 Mattingly||Recruiting|
|Saint Charles, Missouri, United States, 63304|
|Contact: Email Contact via H. Lundbeck A/S|
|Study Director:||Email contact H. Lundbeck A/S||LundbeckClinicalTrials@Lundbeck.com|