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Clinical Trials/NCT03088657
NCT03088657
Unknown
Not Applicable

Mood Disorder Cohort Research Consortium (MDCRC) in Korea

Korea University Anam Hospital1 site in 1 country500 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mood Disorders
Sponsor
Korea University Anam Hospital
Enrollment
500
Locations
1
Primary Endpoint
illness severity and change in patients by using Clinical Global Impression-Bipolar score
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2022
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heon-Jeong Lee, MD, PhD

Professor

Korea University Anam Hospital

Eligibility Criteria

Inclusion Criteria

  • under 25 years old with mood disorder
  • under 35 years old with mood disorder within 2 years of treatment

Exclusion Criteria

  • patients with intellectual disability
  • patients with organic brain injury
  • patients have difficulty reading and understanding the Korean language

Outcomes

Primary Outcomes

illness severity and change in patients by using Clinical Global Impression-Bipolar score

Time Frame: 3months

Secondary Outcomes

  • 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)

Study Sites (1)

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