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Mood DisordersNCT03088657

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

An observational study of Mood Disorders and Bipolar Disorder, run by Korea University Anam Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 35 years
How many people
500 participants
Where
1 siteSouth Korea
Study dates
Sep 2015to Sep 2022
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

South Korea1 site, 1 recruiting

  • Heon-Jeong Lee

    Seoul

    Heon-Jeong Lee, MD, +82 10 2269 7679, leehjeong@korea.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Mood Disorder Cohort Research Consortium (MDCRC) in Korea

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.

Read the 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.

Keywords
Cohort study, early-onset mood disorders
Medical subject headings
Mood Disorders, Bipolar Disorder, Depressive Disorder, Major

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3months

Secondary outcomes (7)

  1. Scores of depressive symptoms as assessed by MADRS

    MADRS : Montgomery-Åsberg Depression Rating Scale

    Measured: 3months

  2. Scores of manic symptoms as assessed by YMRS

    YMRS : Young Mania Rating Scale

    Measured: 3months

  3. 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).

    Measured: 3 months

  4. Sleep

    Daily data from wearable device by using Fitbit charge series.

    Measured: 3months

  5. Activity

    Daily data from wearable device by using Fitbit charge series.

    Measured: 3months

  6. Heart rate

    Daily data from wearable device by using Fitbit charge series.

    Measured: 3months

  7. average monthly cost of treatment for psychiatric, medical, dental, and oriental medicinal management

    Measured: 3months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study startSep 2015
  3. Primary completionJul 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088657
Sponsor's protocol ID
MDCRC
Status last verified
Feb 2019
First submitted
3 Mar 2017
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28096882

  • 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.

    PubMed 21526429

  • 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.

    PubMed 22381955

  • 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.

    PubMed 16877657

  • 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.

    PubMed 21507383

  • 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.

    PubMed 18307587

  • 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.

    PubMed 22408133

  • 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.

    PubMed 15023578

  • 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.

    PubMed 15858064

  • 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.

    PubMed 17048218

  • 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.

    PubMed 22795047

  • 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.

    PubMed 22483292

  • 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.

    PubMed 22086748

  • Yeom JW, Lee JB, Park S, Cho CH, Lee HJ. Optimizing Winter-Type Seasonality Criteria in East Asian Populations: A Machine Learning Approach Using the Seasonal Pattern Assessment Questionnaire. Brain Behav. 2025 Sep;15(9):e70834. doi: 10.1002/brb3.70834.

    PubMed 40898717

  • 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.

    PubMed 39557997

Questions about this trial

What is this clinical trial studying?

An observational study of Mood Disorders and Bipolar Disorder, run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Heon-Jeong Lee, MD, PhD (+82 10 2269 7679, leehjeong@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

illness severity and change in patients by using Clinical Global Impression-Bipolar score (time frame: 3months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088657, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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