BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 553
- 主要终点
- Clinical Evolution of the Disease
研究概览
简要总结
To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.
To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.
To analyse the health status, quality of life and functioning/disability of patients.
详细描述
Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
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
- •Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
- •Patients or their legal representatives have provided informed consent
排除标准
- •Patients are unable to complete or to understand health questionnaires in Spanish language
- •Patients enrolled in clinical trials or other studies
结局指标
主要结局
Clinical Evolution of the Disease
时间窗: 12 months
Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)
时间窗: 12 months
Cardiovascular Risk
时间窗: 12 months
次要结局
- Patient functional impairment(12 months)
- Patient quality of life(12 month)
- Current pattern of treatment in Bipolar Disorder(12 month)
- Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder(1 day)