Status:
RECRUITING
AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Mental Disorder
Eligibility:
All Genders
15-45 years
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) a...
Detailed Description
The investigators have completed the construction of the eye-tracking diagnostic and warning system and have piloted the new system. The plan is to recruit 1,000 individuals at Clinical High Risk for ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06511713
Start Date
July 20 2024
End Date
December 30 2025
Last Update
July 23 2024
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030