A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 814
- 试验地点
- 1
- 主要终点
- Patient gender (%)
研究概览
简要总结
The purpose of this retrospective observational study is to evaluate the characteristics of patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study will also investigate how the medication is used for these patients and if there are any differences in drug utilisation between the included countries. The study is observing patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months following the launch of the product in each country for the MDD indication. A drug utilisation questionnaire will be used to collect study data from patients' medical records.
详细描述
A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent before initiation of any collection of questionnaire data.
- •Documented clinical diagnosis of Major Depressive Disorder, Single Episode, or Recurrent.
- •Initiation of Seroquel XR for treatment of MDD during the period defining the inception cohort, i.e. from 3 months after launch until the index date (12 months after launch).
排除标准
- •If participating in any clinical trial during the time from 3 months after launch until the index date, the patient cannot take part in this study.
结局指标
主要结局
Patient gender (%)
时间窗: Baseline
Daily dose of Seroquel XR (mode and range)
时间窗: follow-up up to nine months
Patient age (mean and range)
时间窗: Baseline
Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)
时间窗: Baseline
Patients hospitalized for any psychiatric condition (n, %)
时间窗: follow-up up to nine months
次要结局
- Patient referral pathway (%)(Baseline)
- Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)(Baseline)
- Participating psychiatrist practice setting (%)(Baseline)