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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mood Disorder Cohort Research Consortium (MDCRC) in Korea

Conditions
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Mood Disorders, Bipolar Disorder, Major Depressive Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| illness severity and change in patients by using Clinical Global Impression-Bipolar score |  | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of depressive symptoms as assessed by MADRS | MADRS : Montgomery-Åsberg Depression Rating Scale | 3months | 
| Scores of manic symptoms as assessed by YMRS | YMRS : Young Mania Rating Scale | 3months | 
| Daily mood chart | subjects 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). | 3 months | 
| Sleep | Daily data from wearable device by using Fitbit charge series. | 3months | 
| Activity | Daily data from wearable device by using Fitbit charge series. | 3months | 
| Heart rate | Daily data from wearable device by using Fitbit charge series. | 3months | 
| average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management |  | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cohort study, early-onset mood disorders