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临床试验/NCT03088657
NCT03088657Unknown不适用

Mood Disorder Cohort Research Consortium (MDCRC) in Korea

Korea University Anam Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heon-Jeong Lee, MD, PhD

Professor

Korea University Anam Hospital

研究点 (1)

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