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

Major Depressive Disorder Clinical Trial

Official title:

Mood Disorder Cohort Research Consortium (MDCRC) in Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088657
• Other study ID #: MDCRC
• Status: Recruiting
• Start date: September 2015
• Est. completion date: September 2022

Study information

• Verified date: February 2019
• Source: Korea University Anam Hospital
• Contact: Heon-Jeong Lee, MD, PhD
• Phone: +82 10 2269 7679
• Email: leehjeong[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders

Locations

Country	Name	City	State
Korea, Republic of	Heon-Jeong Lee	Seoul

Sponsors (10)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Chonnam National University Hospital, Gyeongsang National University Hospital, Ministry of Health & Welfare, Korea, National Center for Mental Health, Korea, Pusan National University Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0 — View Citation

Chang SM, Hong JP, Cho MJ. Economic burden of depression in South Korea. Soc Psychiatry Psychiatr Epidemiol. 2012 May;47(5):683-9. doi: 10.1007/s00127-011-0382-8. Epub 2011 Apr 28. — View Citation

Cho CH, Ahn YM, Kim SJ, Ha TH, Jeon HJ, Cha B, Moon E, Park DY, Baek JH, Kang HJ, Ryu V, An H, Lee HJ. Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study. Psychiatry Investig. 2017 Jan;14(1):100-106. doi: 10.4306/pi.2017.14.1.100. Epub 2016 Dec 29. — View Citation

Dreimüller N, Tadic A, Dragicevic A, Boland K, Bondy B, Lieb K, Laux G, Maier W, Müller MJ, Rao ML, Rietschel M, Röschke J, Zill P, Hiemke C. The serotonin transporter promoter polymorphism (5-HTTLPR) affects the relation between antidepressant serum conc — View Citation

Hunter AM, Leuchter AF, Morgan ML, Cook IA. Changes in brain function (quantitative EEG cordance) during placebo lead-in and treatment outcomes in clinical trials for major depression. Am J Psychiatry. 2006 Aug;163(8):1426-32. — View Citation

Iosifescu DV, Greenwald S, Devlin P, Perlis RH, Denninger JW, Alpert JE, Fava M. Pretreatment frontal EEG and changes in suicidal ideation during SSRI treatment in major depressive disorder. Acta Psychiatr Scand. 2008 Apr;117(4):271-6. doi: 10.1111/j.1600 — View Citation

Kocabas NA. Catechol-O-methyltransferase (COMT) pharmacogenetics in the treatment response phenotypes of major depressive disorder (MDD). CNS Neurol Disord Drug Targets. 2012 May;11(3):264-72. Review. — View Citation

Krömer SA, Kessler MS, Milfay D, Birg IN, Bunck M, Czibere L, Panhuysen M, Pütz B, Deussing JM, Holsboer F, Landgraf R, Turck CW. Identification of glyoxalase-I as a protein marker in a mouse model of extremes in trait anxiety. J Neurosci. 2005 Apr 27;25( — View Citation

Murphy JA, Byrne GJ. Prevalence and correlates of the proposed DSM-5 diagnosis of Chronic Depressive Disorder. J Affect Disord. 2012 Jul;139(2):172-80. doi: 10.1016/j.jad.2012.01.033. Epub 2012 Mar 3. — View Citation

Paige LA, Mitchell MW, Krishnan KR, Kaddurah-Daouk R, Steffens DC. A preliminary metabolomic analysis of older adults with and without depression. Int J Geriatr Psychiatry. 2007 May;22(5):418-23. — View Citation

Suto T, Fukuda M, Ito M, Uehara T, Mikuni M. Multichannel near-infrared spectroscopy in depression and schizophrenia: cognitive brain activation study. Biol Psychiatry. 2004 Mar 1;55(5):501-11. — View Citation

Tenke CE, Kayser J, Manna CG, Fekri S, Kroppmann CJ, Schaller JD, Alschuler DM, Stewart JW, McGrath PJ, Bruder GE. Current source density measures of electroencephalographic alpha predict antidepressant treatment response. Biol Psychiatry. 2011 Aug 15;70( — View Citation

Yang Z, Ma X, Wang Y, Wang J, Xiang B, Wu J, Deng W, Li M, Wang Q, Li T. Association of APC and REEP5 gene polymorphisms with major depression disorder and treatment response to antidepressants in a Han Chinese population. Gen Hosp Psychiatry. 2012 Sep-Oc — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	illness severity and change in patients by using Clinical Global Impression-Bipolar score		3months
Secondary	Scores of depressive symptoms as assessed by MADRS	MADRS : Montgomery-Åsberg Depression Rating Scale	3months
Secondary	Scores of manic symptoms as assessed by YMRS	YMRS : Young Mania Rating Scale	3months
Secondary	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
Secondary	Sleep	Daily data from wearable device by using Fitbit charge series.	3months
Secondary	Activity	Daily data from wearable device by using Fitbit charge series.	3months
Secondary	Heart rate	Daily data from wearable device by using Fitbit charge series.	3months
Secondary	average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management		3months