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Search / Trial NCT07031661

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

Launched by SHANGHAI MENTAL HEALTH CENTER · Jun 12, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Bipolar Disorder High Risk Offspring Atypical Depression Cohort Study Prediction Model

ClinConnect Summary

This clinical trial is studying how to better predict and understand the early signs of bipolar disorder (BD) in young people who are at high risk, such as children and teenagers who have a parent with bipolar disorder or those diagnosed with a type of depression called atypical depression. Bipolar disorder is a serious mental health condition that affects mood, thinking, and daily functioning, and it can be hard to recognize early on. This study aims to find ways to identify the disorder sooner so that treatment can start earlier, which can improve outcomes and help people function better in their daily lives.

If you are between 6 and 18 years old and either have a parent diagnosed with bipolar disorder or have been diagnosed with atypical depression, you might be eligible to join. Healthy children without a family history of psychiatric illness are also being enrolled for comparison. Participants will be followed closely for up to 10 years using an electronic health platform, and various types of information will be collected, including medical, genetic, brain imaging, sleep patterns, and even facial expressions and speech. This careful monitoring will help researchers build a detailed model to predict who might develop bipolar disorder and how early treatment can work best. The study hopes to provide doctors with better tools to personalize care and improve the future health of young people at risk.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • High-risk offsprings of parents with BD: Aged 6-18 yrs, both male and female. Offsprings and parents can sign the writtened informed consent form. At least one of parents was diagnosed with bipolar disorder by two or more senior psychiatric doctor.
  • Atypical depression: Aged 6-18 yrs, both male and female. Patients and parents can sign the writtened informed consent form. Patients was diagnosed with atypical depression by two or more senior psychiatric doctor according to DSM-5. The disease phase and treatment regime are unrestricted.
  • Health control: health individuals with age and gender matched with high-risk offsprings, no psychiatric family history.
  • Exclusion Criteria:
  • High-risk offsprings of parents with BD: HCL-32 total score \> 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.
  • Atypical depression: HCL-32 total score \> 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc. Patients cormobid substance abuse or treated with MECT in recent half a year.
  • Health control: Individuals with psychiatric family history, severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.

About Shanghai Mental Health Center

Shanghai Mental Health Center is a leading institution dedicated to advancing mental health research and treatment. As a prominent clinical trial sponsor, the center focuses on innovative therapeutic approaches and evidence-based practices to address a wide range of psychiatric disorders. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to enhancing patient care through rigorous clinical trials that contribute to the understanding and management of mental health conditions. Its mission is to foster collaboration among researchers, clinicians, and patients to promote mental well-being and improve outcomes in mental health care.

Locations

Shanghai, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported