NCT01770704已完成不适用
Chinese Observation Study of the Clinical Management of Bipolar Disorder
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
- 520
- 试验地点
- 3
- 主要终点
- Number of episodes (depression, mania, hypomania or mixed).
研究概览
简要总结
The objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in China, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Provision of subject informed consent.
- •Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder.
- •Patients who had at least one mood event( depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 3 and 12 months prior to the beginning of the study.
排除标准
- •Inability to complete Patient Reported Outcomes (PROs) questionnaires.
- •Participation in an interventional clinical study in last 12 months.
结局指标
主要结局
Number of episodes (depression, mania, hypomania or mixed).
时间窗: Up to 21 months
次要结局
- Treatments received for Bipolar Disorder: medication classes.(Up to 21 months)
- Treatments received for Bipolar Disorder: medication time.(Up to 21 months)
研究者
研究点 (3)
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