Mood Disorder Cohort Research Consortium (MDCRC) in Korea
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- illness severity and change in patients by using Clinical Global Impression-Bipolar score
研究概览
简要总结
The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in South Korea.
详细描述
The Mood Disorder Cohort Research Consortium (MDCRC) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in South Korea. The study subjects consist of two populations: 1) patients with mood disorders under 25 years old and 2) patients with mood disorders within 2 years of treatment under 35 years old. After successful screening, the subjects are evaluated using baseline assessments and serial follow-up assessments at 3-month intervals. Between the follow-up assessments, subjects are dictated to check their own daily mood status before bedtime using the eMood chart application or a paper mood diary. In addition, wearable activity tracker(Fitbit charge series) is applied for data collection such as activity, sleep, and heart rate during every moments. At the regular visits every 3 months, inter-visit assessments are evaluated based on daily mood charts and interviews with patients. In addition to the daily mood chart, sleep quality, inter-visit major and minor mood episodes, stressful life events, and medical usage pattern with medical expenses are also assessed. Genomic DNA from blood is obtained for genomic analyses. From the MDCRC study, the clinical course, prognosis, and related factors of early-onset mood disorders can be clarified. The MDCRC is also able to facilitate translational research for mood disorders and provide a resource for the convergence study of mood disorders.
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
- — 至 35 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •under 25 years old with mood disorder
- •under 35 years old with mood disorder within 2 years of treatment
排除标准
- •patients with intellectual disability
- •patients with organic brain injury
- •patients have difficulty reading and understanding the Korean language
结局指标
主要结局
illness severity and change in patients by using Clinical Global Impression-Bipolar score
时间窗: 3months
次要结局
- Scores of depressive symptoms as assessed by MADRS(3months)
- Activity(3months)
- Heart rate(3months)
- Sleep(3months)
- Scores of manic symptoms as assessed by YMRS(3months)
- Daily mood chart(3 months)
- average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management(3months)
研究者
Heon-Jeong Lee, MD, PhD
Professor
Korea University Anam Hospital
