Clinical trial NCT05095662: Establish a Specific Cohort Database for Depressive Disorders
Official title: Establish a Specific Cohort Database for Depressive Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depressive Disorder
Keywords: depression
cohort study
database
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Shanghai 10th People's Hospital
name: RenJi Hospital
First posted: 2021-10-27
Enrollment: 80000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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）.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Recruitment of 300 patients who was diagnosed as depressive disorders.
timeFrame: Baseline, and 1,2,3,4,5 years follow-up point
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
name: Yiru Fang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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