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

NCT03088657 | Unknown

• 1 other identifier: MDCRC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Bipolar Disorder; Major Depressive Disorder

Keywords

Cohort study; early-onset mood disorders

Outcome Measures

Primary Outcomes (1)

• illness severity and change in patients by using Clinical Global Impression-Bipolar score

  3months

Secondary Outcomes (7)

• Scores of depressive symptoms as assessed by MADRS

  3months

• Scores of manic symptoms as assessed by YMRS

  3months

• Daily mood chart

  3 months

• Sleep

  3months

• Activity

  3months

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• under 25 years old with mood disorder
• under 35 years old with mood disorder within 2 years of treatment

You may not qualify if:

• patients with intellectual disability
• patients with organic brain injury
• patients have difficulty reading and understanding the Korean language

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Gyeongsang National University Hospital: collaborator
• Pusan National University Hospital: collaborator
• Chonnam National University Hospital: collaborator
• National Center for Mental Health, Korea: collaborator

Study Sites (1)

Heon-Jeong Lee

Seoul, South Korea

RECRUITING

Related Publications (15)

• 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.

  PMID: 28096882 BACKGROUND

• 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.

  PMID: 21526429 RESULT

• 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.

  PMID: 22381955 RESULT

• 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. doi: 10.1176/ajp.2006.163.8.1426.

  PMID: 16877657 RESULT

• 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(4):388-94. doi: 10.1016/j.biopsych.2011.02.016. Epub 2011 Apr 20.

  PMID: 21507383 RESULT

• 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.1600-0447.2008.01156.x. Epub 2008 Feb 26.

  PMID: 18307587 RESULT

• 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. Epub 2012 Mar 9.

  PMID: 22408133 RESULT

• 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. doi: 10.1016/j.biopsych.2003.09.008.

  PMID: 15023578 RESULT

• Kromer SA, Kessler MS, Milfay D, Birg IN, Bunck M, Czibere L, Panhuysen M, Putz 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(17):4375-84. doi: 10.1523/JNEUROSCI.0115-05.2005.

  PMID: 15858064 RESULT

• 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. doi: 10.1002/gps.1690.

  PMID: 17048218 RESULT

• 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-Oct;34(5):571-7. doi: 10.1016/j.genhosppsych.2012.05.015. Epub 2012 Jul 12.

  PMID: 22795047 RESULT

• 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. doi: 10.2174/187152712800672445.

  PMID: 22483292 RESULT

• Dreimuller N, Tadic A, Dragicevic A, Boland K, Bondy B, Lieb K, Laux G, Maier W, Muller MJ, Rao ML, Rietschel M, Roschke J, Zill P, Hiemke C. The serotonin transporter promoter polymorphism (5-HTTLPR) affects the relation between antidepressant serum concentrations and effectiveness in major depression. Pharmacopsychiatry. 2012 May;45(3):108-13. doi: 10.1055/s-0031-1291347. Epub 2011 Nov 15.

  PMID: 22086748 RESULT

• Lim D, Jeong J, Song YM, Cho CH, Yeom JW, Lee T, Lee JB, Lee HJ, Kim JK. Accurately predicting mood episodes in mood disorder patients using wearable sleep and circadian rhythm features. NPJ Digit Med. 2024 Nov 18;7(1):324. doi: 10.1038/s41746-024-01333-z.

  PMID: 39557997 DERIVED

• Cho CH, Lee T, Lee JB, Seo JY, Jee HJ, Son S, An H, Kim L, Lee HJ. Effectiveness of a Smartphone App With a Wearable Activity Tracker in Preventing the Recurrence of Mood Disorders: Prospective Case-Control Study. JMIR Ment Health. 2020 Aug 5;7(8):e21283. doi: 10.2196/21283.

  PMID: 32755884 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood 10cc

MeSH Terms

Conditions

Mood Disorders; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mental Disorders; Bipolar and Related Disorders; Depressive Disorder

Study Officials

• Heon-Jeong Lee, MD, PhD

  'Korea University Anam Hospital' in Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heon-Jeong Lee, MD, PhD

CONTACT

+82 10 2269 7679; leehjeong@korea.ac.kr

Chul-Hyun Cho, MD, PhD

CONTACT

+82 10 9167 2203; david0203@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 23, 2017
• Study Start: September 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)