Actively Recruiting

Age: 6Years - 18Years
All Genders
Healthy Volunteers
NCT07031661

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

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

1200

Participants Needed

1

Research Sites

58 weeks

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, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. This situation will seriously influence one's behaviour or thinking, cognitive, emotional, social and occupational function, causing the heavy burden of disease. But, early recognition and early diagnosis are difficult to achieve at present. Based on the preliminary research results of the project team, it is found that BD can be identified early through specific dimensions, and early recognition is crucial for the prognosis of patients. The earlier the intervention for BD is implemented, the better the prognosis, especially the functional prognosis, but the difficulty lies in how to implement it. Establishing a high-quality clinical cohort of BD high-risk population is a necessary prerequisite. This study intends to establish a high-quality, large-sample cohort through multi-center, long-term and prospective cohort design and enroll 100 BD high-risk patients every year, a total of 400 cases in 4 years. The electronic mental health service platform will be used for ten years of intensive follow-up. Multi-modal data including clinical characteristics, genetic, cognitive, neuroimaging, sleep monitoring, eeg, eye movement, speech, facial expression and movement were collected to construct the database. On this basis, the interaction of biological factors, clinical risk factors, and environmental risk factors in the onset of BD is discussed to establish a big data prediction model for BD onset in high-risk populations. The effective subgroups of early intervention were analyzed and screened. An ethical and individualized prediction model of the effectiveness and safety of early intervention for the BD high-risk population was constructed. It is hoped that the smooth implementation of this project can provide empirical evidence for the early identification, prevention and intervention of BD. To provide clinicians with real data-driven decision-making guidance to assist in selecting personalized and precise treatment; Ultimately promote the prognosis and functional recovery of BD patients.

CONDITIONS

Official 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...

  • High-risk offspring of parents with bipolar disorder aged 6 to 18 years, male or female, with written informed consent from offspring and parents, and parental diagnosis confirmed by two or more senior psychiatric doctors
  • Patients aged 6 to 18 years with atypical depression diagnosed by two or more senior psychiatric doctors using DSM-5, male or female, with written informed consent from patients and parents, regardless of disease phase or treatment
  • Healthy individuals matched by age and gender with no psychiatric family history
Not Eligible

You will not qualify if you...

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

AI-Screening

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