AI technology for early warning of mental disorders using eye imaging and tracking
Artificial Intelligence-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Images and High-Speed Eye-Tracking Trajectories
This study is testing if using eye images and tracking can help doctors spot and predict mental health issues earlier in people who are at risk or already have mental disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06511713 on ClinicalTrials.gov |
What this trial studies
This project collects eye-tracking and fundus imaging data from individuals seeking mental health services to develop AI models for classifying and predicting common mental disorders. By integrating dynamic eye-tracking data with static fundus imaging, the study aims to create objective diagnostic tools that can assist clinicians in making accurate diagnoses and predicting adverse outcomes. The study plans to recruit 2,000 participants, including those at clinical high risk for psychosis and patients with various mental disorders, to validate these predictive models. The system will be integrated into existing hospital information systems to provide real-time feedback for clinicians.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 45 who are drug-naïve and meet specific diagnostic criteria for mental disorders.
Not a fit: Patients with acute or chronic renal failure, liver cirrhosis, or significant abnormal laboratory results may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and objective diagnoses of mental disorders, improving patient outcomes.
How similar studies have performed: While the integration of AI with eye-tracking for mental health diagnostics is a novel approach, similar studies have shown promise in using technology for early detection of mental health issues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * be aged 14 to 45-year-old * have had at least 6-years of primary education * be drug-naïve * be understanding the survey, be willing to enrol in the study and sign the informed consent * Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome * Meets ICD-11 diagnostic criteria for schizophrenia * Meets ICD-11 diagnostic criteria for mood disorders * Meets ICD-11 diagnostic criteria for anxiety disorders * Meets ICD-11 diagnostic criteria for neurocognitive disorders Exclusion Criteria: * Acute or chronic renal failure; liver cirrhosis or active liver diseases * Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects * Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L * Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial * Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial * Stroke within the last month * Participating in any clinical trial within 30 days before the baseline * Other situations judged by the investigators not to be suitable for the clinical trial
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: TianHong Zhang, Doctor — Shanghai Mental Health Center
- Study coordinator: TianHong Zhang, Doctor
- Email: zhang_tianhong@126.com
- Phone: 13127577024
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.