Actively Recruiting

Age: 15Years - 45Years
All Genders
ID06511713

Artificial Intelligence-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Images and High-Speed Eye-Tracking Trajectories

Led by Shanghai Mental Health Center · Updated on 2024-07-23

2000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting eye-tracking data and high-resolution images of the back of the eye (fundus imaging) from individuals seeking help for mental health issues. The study aims to use artificial intelligence techniques, including convolutional neural networks, to combine these dynamic and static data types. This approach hopes to develop models that can classify common mental disorders and provide early warnings, assisting clinicians with objective diagnosis and risk prediction for adverse outcomes. The study plans to recruit 1,000 individuals at clinical high risk for psychosis and 1,000 patients diagnosed with common mental disorders, including schizophrenia, mood disorders, anxiety disorders, and cognitive impairment in the elderly. Participants will continue their routine clinical treatment as this is an observational study without additional interventions. The system developed will be integrated with hospital information systems and include real-time feedback reports to support clinical decision-making. Participants will undergo eye-tracking and fundus examinations over one year to collect data for analysis. Researchers will monitor eye-tracking fixation point trajectories and fundus images as the primary outcomes. The study will refine variables to improve diagnostic accuracy and integrate findings with previous research data. The total participation duration varies but involves natural follow-up alongside standard care, aiming to create tools for better mental disorder diagnosis and warning.

CONDITIONS

Brief Title

AI-Assisted Rapid Warning for Mental Disorders Based on High-Resolution Fundus Imaging and High-Speed Eye-Tracking

Who Can Participate

Age: 15Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be aged 14 to 45 years old
  • Have had at least 6 years of primary education
  • Be drug-nafve (not previously treated with psychiatric drugs)
  • Understand the survey and be willing to enroll and sign informed consent
  • Meet Criteria of Prodromal Syndrome via Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), fulfilling at least one: brief intermittent psychotic syndrome, attenuated positive symptom syndrome, or genetic risk and deterioration syndrome
  • Meet ICD-11 diagnostic criteria for schizophrenia
  • Meet ICD-11 diagnostic criteria for mood disorders
  • Meet ICD-11 diagnostic criteria for anxiety disorders
  • Meet ICD-11 diagnostic criteria for neurocognitive disorders
Not Eligible

You will not qualify if you...

  • Have acute or chronic renal failure, liver cirrhosis, or active liver diseases
  • Have abnormal laboratory test results considered clinically significant by researchers
  • Have severe or unstable physical diseases, including neurological disorders, congestive heart failure, angina, myocardial infarction, arrhythmia, untreated or uncontrolled hypertension, malignant tumors, immune compromise, or blood glucose above 12 mmol/L
  • Have abused alcohol within 30 days or had alcohol/drug dependence within 6 months before the trial
  • Be pregnant or lactating, or be of childbearing age without effective contraception or planning pregnancy within 3 months after trial start
  • Have had a stroke within the last month
  • Be participating in another clinical trial within 30 days before baseline
  • Any other conditions judged unsuitable by investigators for the clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 1 year

Participants who undergo routine clinical treatment are observed using an AI-assisted eye-tracking and fundus imaging system to validate predictive and diagnostic models for mental disorders.

Periodic visits as part of routine clinical treatment

Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

T

TianHong Zhang, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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