NCT07311668

Validation of the Accuracy of an AI-Based System for Diagnosing Depressive Disorders

Accuracy of an Artificial Intelligence-Based System for Diagnosing Depressive Disorders: A Paired Comparison With Psychiatrist Clinical Diagnoses

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The trial aimed to evaluate the accuracy of an artificial intelligence-based system for diagnosing depressive disorders. Specifically, it sought to determine whether the system's assessment validity is non-inferior to that of psychiatric specialists.

Detailed description

This study evaluates the performance of the AI-assisted diagnostic system for identifying depressive disorders and its applicability in clinical settings. Utilizing a paired design with psychiatrists' clinical diagnoses as the gold standard, the study compares the system's diagnostic results with those of physicians to determine sensitivity and specificity, thus validating its clinical effectiveness in real-world outpatient scenarios. Additionally, standardized scales are used to assess users' perceptions of the system's usability, trustworthiness, and satisfaction, offering evidence to support the clinical integration of AI technology in mental health screening.

Conditions

• Depressive Disorder

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China