A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- To define the potential bipolarity status in treatment resistant MDD patient population
研究概览
简要总结
The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.
研究设计
- 研究类型
- Observational
- 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
- •Written informed consent form
- •Male and Female age: 18-65 years
- •Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)
- •Treatment resistance defined as non-response to at least 2 antidepressants given in an ade
排除标准
- •Patients already participating in clinical trial or any other interventional study
- •Patients unable to understand HCL-32 item meaning
结局指标
主要结局
To define the potential bipolarity status in treatment resistant MDD patient population
时间窗: 3 months
assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening
Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated.
时间窗: 3 months
次要结局
- To collect patient characteristics by evaluation of demographic information(3 months)
- To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode(3 months)
- To collect information on the ongoing treatment(3 months)