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

NCT07311668 | Not Yet Recruiting

• 1 other identifier: MZhao-023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy (Sensitivity, Specificity, and Area Under the Curve) of the AI-Based Screening System for Depressive Disorders

  In this study, the evaluation results of the subjects were taken as the gold standard based on the diagnostic conclusions of psychiatrists. The screening results of the aided-diagnostic system were compared with the diagnostic conclusions of the psychiatrists to verify the screening effectiveness of this system. Sensitivity : Calculated as \[True Positives / (True Positives + False Negatives)\], evaluating the AI system's ability to correctly identify patients with depression. Specificity : Calculated as \[True Negatives / (True Negatives + False Positives)\], evaluating the AI system's ability to correctly exclude non-depressed individuals.Area Under the Receiver Operating Characteristic Curve (AUC), which comprehensively evaluates the diagnostic discriminative power of the system by plotting sensitivity versus 1-specificity across different decision thresholds and calculating the AUC value .

  through study completion, an average of 1 week

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study includes the subjects with depressive disorders and healthy control into the experiment. Depressive individuals for the study will be recruited from actual outpatient patients at the Shanghai Mental Health Center. The healthy control will be recruited through public advertisements, both online and offline. Psychiatrists will be recruited through public advertisements by the Shanghai Mental Health Center.

You may qualify if:

• In accordance with ICD-11 for Depressive Disorders;
• Between the ages of 18-60;
• Ability to use computers or smartphone;
• Native Chinese speaker;

You may not qualify if:

• With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment;
• With a high risk of suicide or self-injury;
• With severe physical diseases, central nervous system diseases, or substance abuse;
• With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.
• Not meet ICD-11 criteria for Mental Disorders;
• Between the ages of 18-60;
• Ability to use computers or smartphone;
• Native Chinese speaker;
• With mental illness, or unable to complete the required assessment and treatment;
• With severe physical diseases, central nervous system diseases, or substance abuse;
• With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.
• Over 18 years old;
• A minimum of three years' experience in anxiety and other mental health fields;
• Intermediate or higher professional title;
• Currently employed in the selected test region;

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 31, 2025
• Study Start: February 1, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)