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Active, Not Recruiting

NCT Number: NCT05095662

Establish a Specific Cohort Database for Depressive Disorders

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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