Predicting bipolar disorder risk in children and teens with family history or atypical depression
The Establishment of Disease Prediction Model for High-risk Population With Bipolar Disorder Based on Multimodal Data: A Multicenter, Large Sample, Prospective Cohort Study
This project will try a prediction model to see if it can identify children and adolescents at high risk for bipolar disorder, including offspring of people with bipolar disorder and youths with atypical depression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07031661 on ClinicalTrials.gov |
What this trial studies
This observational cohort will enroll children and adolescents aged 6–18 who are offspring of a parent with bipolar disorder, youths diagnosed with atypical depression, and age- and sex-matched healthy controls. Participants will undergo structured clinical interviews, standardized symptom scales, family-history collection, and routine medical assessments to generate data for predictive modeling. No experimental treatments are administered; the aim is to identify clinical patterns and risk markers that precede bipolar disorder onset. Recruitment and data collection are based at Shanghai Mental Health Center and collaborating hospitals in Shanghai.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6–18 who are offspring of a parent diagnosed with bipolar disorder, or who have DSM-5 atypical depression, and who can provide informed consent with a parent/guardian (age- and sex-matched healthy controls are also eligible).
Not a fit: Individuals already diagnosed with bipolar disorder, those with HCL-32 scores >12, current Axis I psychiatric diagnoses on screening, or severe physical illnesses are excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the prediction model could help identify at-risk youth earlier so clinicians can offer closer monitoring or earlier interventions to improve long-term outcomes.
How similar studies have performed: Previous cohort and biomarker research has shown promising signals that clinical features can predict bipolar onset, but robust, widely validated prediction models are still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.