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Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety

NCT07279038 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2025-12-12

No results posted yet for this study

Summary

This study is a large-scale pivotal clinical validation of the AI-COA® software device. The purpose is to confirm the tool's accuracy and performance across a demographically diverse population of adults with Major Depressive Disorder (MDD), ensuring it functions fairly and reliably across different subgroups.

Conditions

  • Depression Disorders
  • Anxiety Disorders

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Deliberate Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Aafjes · Deliberate Solutions Inc.

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2029-08-28
Completion
2029-08-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279038 on ClinicalTrials.gov