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

• Conditions: Major Depressive Disorder; Bipolar Disorder; Mood Disorders

• Registration Number: NCT03088657
• Lead Sponsor: Korea University Anam Hospital

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Primary Completion: 2022-07
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
illness severity and change in patients by using Clinical Global Impression-Bipolar score	3months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heon-Jeong Lee; 🇰🇷 Seoul, Korea, Republic of