NCT06511713 AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking
| NCT ID | NCT06511713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Mental Health Center |
| Condition | Mental Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-07-20 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-07-20 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project aims to collect eye-tracking trajectories and fundus imaging data from individuals seeking mental health services. By utilizing artificial intelligence, combining dynamic (eye-tracking) and static (fundus) data, and employing convolutional neural network analysis methods, the investigators will develop models for the classification and early warning of common mental disorders. These models will assist clinicians in making objective diagnoses of common mental disorders and in predicting the risk of adverse outcomes, thereby addressing the significant technical bottleneck of the current lack of objective diagnostic and warning instruments for mental disorders.
Eligibility 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
Contact & Investigator
TianHong Zhang, Doctor
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06511713 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 45 Years, studying Mental Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511713 currently recruiting?
Yes, NCT06511713 is actively recruiting participants. Contact the research team at zhang_tianhong@126.com for enrollment information.
Where is the NCT06511713 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06511713 clinical trial?
NCT06511713 is sponsored by Shanghai Mental Health Center. The principal investigator is TianHong Zhang, Doctor at Shanghai Mental Health Center. The trial plans to enroll 2,000 participants.