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NCT Number: NCT07311668

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

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.

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Subjects with anxiety disorders （1）Inclusion Criteria:
  • In accordance with ICD-11 for Depressive Disorders;
  • Between the ages of 18-60;
  • Ability to use computers or smartphone;
  • Native Chinese speaker;
  • Signing informed consent. （2）Exclusion Criteria:
  • 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.
  • Health Control （1）Inclusion Criteria:
  • Not meet ICD-11 criteria for Mental Disorders;
  • Between the ages of 18-60;
  • Ability to use computers or smartphone;
  • Native Chinese speaker;
  • Signing informed consent. （2）Exclusion Criteria:
  • 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.
  • Psychiatrist （1）Inclusion Criteria:
  • 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;
  • Signing informed consent.

Treatment and study plan

Primary outcomes

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

    Time frame: through study completion, an average of 1 week

    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 .

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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