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Establish a Specific Cohort Database for Depressive Disorders

NCT ID: NCT05095662

Last Updated: 2021-10-27

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

ACTIVE_NOT_RECRUITING

Total Enrollment

80000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-12-31

Brief Summary

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Depression is characterized by high prevalence, high recurrence rate, high disability rate, high suicide rate, and heavy disease burden. However, the diagnosis, treatment, and prognosis of depression are difficult to meet the clinical needs at present. This study plans to integrate a large sample of hospital clinical data, laboratory examination data, brain imaging, and electrophysiological data, as well as audio-visual data, to establish a database for depressive disorder, and long-term follow-up to form a specific disease cohort. This study will provide a scientific basis for exploring biomarkers related to objective diagnosis and treatment of depression.

Detailed Description

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Together with three tertiary hospitals in Shanghai, Shanghai Tenth People's Hospital, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, and Zhongshan Hospital affiliated to Fudan University, Shanghai Mental Health Center will take a lead to establish a big database focused on depressive disorders. Expert consensus will be used to determine the standard for the dataset. Real-world data will be include. To establish a depressive disorders-specific database with multiple functions, such as data insight, data retrieval, cohort project establishment, follow-up, and statistical analysis.

Conditions

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Depressive Disorder

Keywords

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depression cohort study database

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 18-75
* Meeting ICD-10 depressive episode criteria (F32, F33, F34, F38, F39)
* Cultural, social and educational background sufficient to understand informed consent and research content
* Agree to participate in this study

Exclusion Criteria

* Exclude other mental disorders such as bipolar disorder and schizophrenia (but not comorbidities)
* Patients with a history of brain injury or cerebrovascular accident, myocardial infarction, severe liver cirrhosis, acute and chronic renal failure, severe diabetes, aplastic anemia, moderate and severe malnutrition and other serious physical diseases of the nervous, heart, liver, kidney, endocrine and blood systems
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yiru Fang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7.

Reference Type BACKGROUND
PMID: 19524780 (View on PubMed)

Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.

Reference Type BACKGROUND
PMID: 15939839 (View on PubMed)

Gunaratne P, Lloyd AR, Vollmer-Conna U. Mood disturbance after infection. Aust N Z J Psychiatry. 2013 Dec;47(12):1152-64. doi: 10.1177/0004867413503718. Epub 2013 Sep 20.

Reference Type BACKGROUND
PMID: 24056922 (View on PubMed)

Reppermund S, Ising M, Lucae S, Zihl J. Cognitive impairment in unipolar depression is persistent and non-specific: further evidence for the final common pathway disorder hypothesis. Psychol Med. 2009 Apr;39(4):603-14. doi: 10.1017/S003329170800411X. Epub 2008 Jul 30.

Reference Type BACKGROUND
PMID: 18667101 (View on PubMed)

Anoushiravani AA, Patton J, Sayeed Z, El-Othmani MM, Saleh KJ. Big Data, Big Research: Implementing Population Health-Based Research Models and Integrating Care to Reduce Cost and Improve Outcomes. Orthop Clin North Am. 2016 Oct;47(4):717-24. doi: 10.1016/j.ocl.2016.05.008. Epub 2016 Aug 8.

Reference Type BACKGROUND
PMID: 27637658 (View on PubMed)

Murphy DR, Meyer AN, Bhise V, Russo E, Sittig DF, Wei L, Wu L, Singh H. Computerized Triggers of Big Data to Detect Delays in Follow-up of Chest Imaging Results. Chest. 2016 Sep;150(3):613-20. doi: 10.1016/j.chest.2016.05.001. Epub 2016 May 10.

Reference Type BACKGROUND
PMID: 27178786 (View on PubMed)

Auffray C, Balling R, Barroso I, Bencze L, Benson M, Bergeron J, Bernal-Delgado E, Blomberg N, Bock C, Conesa A, Del Signore S, Delogne C, Devilee P, Di Meglio A, Eijkemans M, Flicek P, Graf N, Grimm V, Guchelaar HJ, Guo YK, Gut IG, Hanbury A, Hanif S, Hilgers RD, Honrado A, Hose DR, Houwing-Duistermaat J, Hubbard T, Janacek SH, Karanikas H, Kievits T, Kohler M, Kremer A, Lanfear J, Lengauer T, Maes E, Meert T, Muller W, Nickel D, Oledzki P, Pedersen B, Petkovic M, Pliakos K, Rattray M, I Mas JR, Schneider R, Sengstag T, Serra-Picamal X, Spek W, Vaas LA, van Batenburg O, Vandelaer M, Varnai P, Villoslada P, Vizcaino JA, Wubbe JP, Zanetti G. Making sense of big data in health research: Towards an EU action plan. Genome Med. 2016 Jun 23;8(1):71. doi: 10.1186/s13073-016-0323-y.

Reference Type BACKGROUND
PMID: 27338147 (View on PubMed)

Other Identifiers

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SHDC2020CR6023

Identifier Type: -

Identifier Source: org_study_id