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Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

Mood Disorder Cohort Research Consortium (MDCRC) in Korea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03088657
Enrollment
500
Registered
2017-03-23
Start date
2015-09-30
Completion date
2022-09-30
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder, Mood Disorders

Keywords

Cohort study, early-onset mood disorders

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.

Interventions

None listed

Sponsors

Ministry of Health & Welfare, Korea
CollaboratorOTHER_GOV
Seoul National University Hospital
CollaboratorOTHER
Severance Hospital
CollaboratorOTHER
Seoul National University Bundang Hospital
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Gyeongsang National University Hospital
CollaboratorOTHER
Pusan National University Hospital
CollaboratorOTHER
Chonnam National University Hospital
CollaboratorOTHER
National Center for Mental Health, Korea
CollaboratorUNKNOWN
Korea University Anam Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 35 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. patients with intellectual disability 2. patients with organic brain injury 3. patients have difficulty reading and understanding the Korean language

Design outcomes

Primary

MeasureTime frame
illness severity and change in patients by using Clinical Global Impression-Bipolar score3months

Secondary

MeasureTime frameDescription
Scores of manic symptoms as assessed by YMRS3monthsYMRS : Young Mania Rating Scale
Daily mood chart3 monthssubjects are dictated to check their own daily mood status before bedtime using the eMood chart application or a paper mood diary. Patients are provided a daily mood chart that asks for mood state (-3 to +3), energy level (-3 to +3), anxiety (0-3), irritability (0-3).
Sleep3monthsDaily data from wearable device by using Fitbit charge series.
Scores of depressive symptoms as assessed by MADRS3monthsMADRS : Montgomery-Åsberg Depression Rating Scale
Heart rate3monthsDaily data from wearable device by using Fitbit charge series.
average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management3months
Activity3monthsDaily data from wearable device by using Fitbit charge series.

Countries

South Korea

Contacts

Primary ContactHeon-Jeong Lee, MD, PhD
leehjeong@korea.ac.kr+82 10 2269 7679
Backup ContactChul-Hyun Cho, MD, PhD
david0203@gmail.com+82 10 9167 2203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026