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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 992
- 试验地点
- 106
- 主要终点
- Sheehan Disability Scale (SDS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Patients initiating vortioxetine treatment
Patients with major depressive disorder initiating treatment with vortioxetine
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Sheehan Disability Scale (SDS)
时间窗: 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
次要结局
- Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)(Change since baseline at week 12 and 24)
- The Patient Health Questionnaire - nine items (PHQ-9)(Change since baseline at week 12 and 24)