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.
Study Type
OBSERVATIONAL
Enrollment
992
Treatment with vortioxetine as per local SmPC
Harmonex Neuroscience Research Inc (US0072)
Dothan, Alabama, United States
Center For Advanced Improvement (US0011)
Tucson, Arizona, United States
Pharmacology Research Institute (US0045)
Newport Beach, California, United States
North County Clinical Research (Nccr) (US0071)
Oceanside, California, United States
Breakthrough Clinical Trials (US0074)
San Bernardino, California, United States
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
Time frame: Change since baseline at week 12 and 24
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
Time frame: 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
Time frame: Change since baseline at week 12 and 24
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Viking Clinical Research Center LLC (US0033)
Temecula, California, United States
Da Vinci Research Institute (US0063)
Boca Raton, Florida, United States
Sarkis Clinical Trials (US0066)
Gainesville, Florida, United States
Maxblue Institute (US0038)
Hialeah, Florida, United States
Office Of Amit Vijapura, Md (US0057)
Jacksonville, Florida, United States
...and 96 more locations