Establish a Specific Cohort Database for Depressive Disorders

Active, not recruiting

• Conditions: Depressive Disorder

• Registration Number: NCT05095662
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

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 Timeline

• Status Verified: 2021-04
• Study Start: 2021-06-01
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Last Update Submitted: 2021-10-14
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 years	Have 80000 patients been included.

Secondary Outcome Measures

Name	Time	Method
Recruitment of 300 patients who was diagnosed as depressive disorders.	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China