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

NCT ID: NCT03088657

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Mood Disorders Bipolar Disorder Major Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

National Center for Mental Health, Korea

UNKNOWN

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heon-Jeong Lee, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heon-Jeong Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

'Korea University Anam Hospital' in Seoul, Korea

Locations

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Heon-Jeong Lee

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Heon-Jeong Lee, MD, PhD

Role: CONTACT

+82 10 2269 7679

Chul-Hyun Cho, MD, PhD

Role: CONTACT

+82 10 9167 2203

Facility Contacts

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Heon-Jeong Lee, MD

Role: primary

+82 10 2269 7679

References

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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.

Reference Type BACKGROUND
PMID: 28096882 (View on PubMed)

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.

Reference Type RESULT
PMID: 21526429 (View on PubMed)

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.

Reference Type RESULT
PMID: 22381955 (View on PubMed)

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.

Reference Type RESULT
PMID: 16877657 (View on PubMed)

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.

Reference Type RESULT
PMID: 21507383 (View on PubMed)

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.

Reference Type RESULT
PMID: 18307587 (View on PubMed)

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.

Reference Type RESULT
PMID: 22408133 (View on PubMed)

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.

Reference Type RESULT
PMID: 15023578 (View on PubMed)

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.

Reference Type RESULT
PMID: 15858064 (View on PubMed)

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.

Reference Type RESULT
PMID: 17048218 (View on PubMed)

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.

Reference Type RESULT
PMID: 22795047 (View on PubMed)

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.

Reference Type RESULT
PMID: 22483292 (View on PubMed)

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.

Reference Type RESULT
PMID: 22086748 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39557997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32755884 (View on PubMed)

Other Identifiers

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MDCRC

Identifier Type: -

Identifier Source: org_study_id

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