Clinical trial NCT03088657: Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Official title: Mood Disorder Cohort Research Consortium (MDCRC) in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mood Disorders
Bipolar Disorder
Major Depressive Disorder
Keywords: Cohort study
early-onset mood disorders
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Seoul National University Hospital
name: Severance Hospital
name: Seoul National University Bundang Hospital
name: Samsung Medical Center
name: Gyeongsang National University Hospital
name: Pusan National University Hospital
name: Chonnam National University Hospital
name: National Center for Mental Health, Korea
First posted: 2017-03-23
Enrollment: 500
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mood disorder patients who fulfill the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for major depressive disorder, bipolar I disorder, or bipolar II disorder

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.

Eligibility criteria: 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

Primary outcomes:
measure: illness severity and change in patients by using Clinical Global Impression-Bipolar score
timeFrame: 3months
Secondary outcomes:
measure: Scores of depressive symptoms as assessed by MADRS
timeFrame: 3months
measure: Scores of manic symptoms as assessed by YMRS
timeFrame: 3months
measure: Daily mood chart
timeFrame: 3 months
measure: Sleep
timeFrame: 3months
measure: Activity
timeFrame: 3months
measure: Heart rate
timeFrame: 3months
measure: average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management
timeFrame: 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Heon-Jeong Lee
Study officials:
affiliation: 'Korea University Anam Hospital' in Seoul, Korea
name: Heon-Jeong Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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