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

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ClinicalTrials.gov Identifier: NCT03088657
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Severance Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Gyeongsang National University Hospital
Pusan National University Hospital
Chonnam National University Hospital
National Center for Mental Health, Korea
Information provided by (Responsible Party):
Heon-Jeong Lee, MD, PhD, 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.

Condition or disease
Mood Disorders Bipolar Disorder Major Depressive Disorder

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 Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Mood Disorder Cohort Research Consortium (MDCRC) in Korea
Study Start Date : September 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders




Primary Outcome Measures :
  1. illness severity and change in patients by using Clinical Global Impression-Bipolar score [ Time Frame: 3months ]

Secondary Outcome Measures :
  1. Scores of depressive symptoms as assessed by MADRS [ Time Frame: 3months ]
    MADRS : Montgomery-Åsberg Depression Rating Scale

  2. Scores of manic symptoms as assessed by YMRS [ Time Frame: 3months ]
    YMRS : Young Mania Rating Scale

  3. Daily mood chart [ Time Frame: 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).

  4. Sleep [ Time Frame: 3months ]
    Daily data from wearable device by using Fitbit charge series.

  5. Activity [ Time Frame: 3months ]
    Daily data from wearable device by using Fitbit charge series.

  6. Heart rate [ Time Frame: 3months ]
    Daily data from wearable device by using Fitbit charge series.

  7. average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management [ Time Frame: 3months ]

Biospecimen Retention:   Samples With DNA
blood 10cc


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088657


Contacts
Contact: Heon-Jeong Lee, MD, PhD +82 10 2269 7679 leehjeong@korea.ac.kr
Contact: Chul-Hyun Cho, MD, PhD +82 10 9167 2203 david0203@gmail.com

Locations
Korea, Republic of
Heon-Jeong Lee Recruiting
Seoul, Korea, Republic of
Contact: Heon-Jeong Lee, MD    +82 10 2269 7679    leehjeong@korea.ac.kr   
Sponsors and Collaborators
Korea University Anam Hospital
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Severance Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Gyeongsang National University Hospital
Pusan National University Hospital
Chonnam National University Hospital
National Center for Mental Health, Korea
Investigators
Principal Investigator: Heon-Jeong Lee, MD, PhD 'Korea University Anam Hospital' in Seoul, Korea

Publications of Results:

Other Publications:
Responsible Party: Heon-Jeong Lee, MD, PhD, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03088657     History of Changes
Other Study ID Numbers: MDCRC
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Heon-Jeong Lee, MD, PhD, Korea University Anam Hospital:
Cohort study
early-onset mood disorders

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders