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临床试验/NCT05095662
NCT05095662进行中(未招募)不适用

Establish a Specific Cohort Database for Depressive Disorders

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 80,000 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80,000
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 3 years

Have 80000 patients been included.

次要结局

  • Recruitment of 300 patients who was diagnosed as depressive disorders.(Baseline, and 1,2,3,4,5 years follow-up point)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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