Establish a Specific Cohort Database for Depressive Disorders

October 14, 2021 updated by: Shanghai Mental Health Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Depressive disorder cohort study: Outpatient or inpatient patients in Shanghai Mental Health Center, Shanghai Zhongshan Hospital, Renji Hospital and Shanghai Tenth People's Hospital were included in this cohort study if the patients agreed to participate in this study and the patients with depressive disorder met the inclusion and exclusion criteria.
  2. Construction of standard database for depression: All inpatients and outpatients of Shanghai Mental Health Center will be included in the special database if they meet the diagnostic criteria for depression（ICD-10）.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct the structured data set for depression by integrating a large sample of outpatient and inpatient clinical data, blood tests, psychological tests, and brain imaging data.
Time Frame: 3 years
Have 80000 patients been included.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment of 300 patients who was diagnosed as depressive disorders.
Time Frame: Baseline, and 1,2,3,4,5 years follow-up point
In order to: collect demographic and sociological information., clinical data, social function, cognitive function, and blood index test. Collection of Audio-Visual, as well as brain imaging or electrophysiology if patients agreed to participate in these tests.
Baseline, and 1,2,3,4,5 years follow-up point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Shanghai Zhongshan Hospital
RenJi Hospital
Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Yiru Fang, M.D., Ph.D., Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2026

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (ACTUAL)

October 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC2020CR6023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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