Actively Recruiting

Age: 6Years - 18Years
All Genders
Healthy Volunteers
ID07031661

The Establishment of Disease Prediction Model for High-risk Population With Bipolar Disorder Based on Multimodal Data: A Multicenter, Large Sample, Prospective Cohort Study

Led by Shanghai Mental Health Center · Updated on 2025-06-22

1200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Shanghai Mental Health Center

Lead Sponsor

S

Shanghai Mental Health Center, Hongkou District

Collaborating Sponsor

AI-Summary

What this Trial Is About

Bipolar disorder (BD) is a serious mental illness that tends to run in families and affects behavior, thinking, emotions, social interactions, and work. It has characteristics like high prevalence, frequent recurrence, and early onset. Early recognition and diagnosis are challenging but important for better outcomes. This research aims to create a large, high-quality group of BD high-risk individuals by enrolling 400 participants over four years and following them intensively for ten years using an electronic mental health platform. The study will collect various types of data including clinical, genetic, cognitive, neuroimaging, sleep, EEG, eye movement, speech, facial expression, and movement to understand how biological, clinical, and environmental factors interact in BD onset. The study is observational and includes three groups: children aged 6 to 18 who have at least one parent with BD, children with atypical depression diagnosed by DSM-5 criteria, and healthy children matched by age and gender without psychiatric family history. Participants will be assessed yearly for four years, including brain scans and multiple follow-ups to track the development of mental illnesses, brain structure and function, cognitive function, sleep quality, quality of life, and genetic features. Participants will be involved in annual evaluations for four years, including clinical assessments and brain imaging. Researchers will monitor the differences in development among the three groups over time. The main outcomes focus on the prevalence of mental illness, brain development, and multi-modal feature changes. Secondary outcomes include cognitive function, sleep quality, quality of life, and genetic differences. This long-term follow-up aims to develop predictive models for BD onset and guide early, personalized interventions for those at high risk.

CONDITIONS

Brief Title

A Cohort Study of Disease Prediction Model for High-risk Population With Bipolar Disorder

Who Can Participate

Age: 6Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 18 years, both male and female
  • Offsprings with at least one parent diagnosed with bipolar disorder by two or more senior psychiatric doctors
  • Patients diagnosed with atypical depression by two or more senior psychiatric doctors according to DSM-5 criteria
  • Healthy children matched by age and gender with high-risk offsprings, with no psychiatric family history
  • Written informed consent signed by participants and their parents
Not Eligible

You will not qualify if you...

  • High-risk offsprings with HCL-32 total score greater than 12
  • Individuals diagnosed with bipolar disorder or showing symptoms of Axis I psychiatric disorders per K-SADS-PL screening
  • Individuals with severe physical diseases including kidney, liver, or nervous system disorders
  • Patients with atypical depression who have comorbid substance abuse or received MECT treatment in the past six months
  • Healthy controls with psychiatric family history or severe physical diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - 4 years

Participants are followed over 4 years with annual visits to assess mental health, brain structure and function, cognitive function, sleep quality, quality of life, and genetic phenotypes.

Annual visits for up to 4 years

Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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