NCT01427439已完成不适用
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,455
- 试验地点
- 1
- 主要终点
- Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
研究概览
简要总结
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module)
- •Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician
- •The patient will present within the normal course of care, for either a first or subsequent episode of depression
排除标准
- •Schizophrenia or other psychotic disorders
- •Bipolar disorder
- •Dementia or other neurodegenerative disease significantly impacting cognitive functioning
- •Mood disorder due to a general medical condition or substances
- •Acute suicidality
- •Patient treated for depression by a combination of different antidepressant treatments at the time of the consultation
- •Other exclusion criteria may apply.
结局指标
主要结局
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
时间窗: At baseline
Patients' functioning assessed by the SDS total score
时间窗: At 12 months
次要结局
- Associations between the patients' clinical condition measured as score on Clinical Global Improvement Severity scale (CGI-S) and of patients' functioning measured as total score on SDS(At baseline)
- Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS(At 24 months)
研究者
研究点 (1)
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