NCT01397903已完成不适用
A Cross-sectional Observational Study to Describe Treatment Management of Patients With Major Depressive Disorder (MDD) and Inadequate Response to Antidepressants in Greece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2
研究概览
简要总结
The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.
详细描述
A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Diagnosis of MDD as per DSM-IV
- •Patients with an inadequate disease control during antidepressant therapy
- •Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study.
排除标准
- •Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I,
- •Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another study
结局指标
主要结局
To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2
时间窗: At week 4 after the commencement of add-on therapy
次要结局
- Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication(At week 4 following the onset of add-on medication)
- Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%(At week 4 following the initiation of add-on drug therapy.)
- Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.(At week 4 after the commencement of add-on therapy)
研究者
研究点 (1)
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