NCT07279038

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

Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Deliberate Solutions Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The SEQUOIA-3 study is a Comprehensive U.S. Clinical Validation of the AI-generated Clinical Outcome Assessment (AI-COA®) for depression and anxiety. This observational study supports the clinical validation of a digital tool intended to measure depression severity using audiovisual data from clinical interviews. The study builds on previous research to establish the tool's validity for regulatory qualification. Key elements of the study include: Diverse Enrollment: The study will prospectively enroll a large, stratified sample to ensure adequate representation across sex, race, and ethnicity, as well as a full range of symptom severity (from remission to severe). Validation: The software's severity scores will be compared against a "ground truth" standard derived from the consensus of independent human raters. Remote Assessment: Participants will complete standard clinical interviews and self-report measures via secure video conferencing. The results will be used to demonstrate the tool's generalizability and its ability to provide unbiased assessments across different patient populations.

Conditions

• Depression Disorders
• Anxiety Disorders

Timeline

• Start date: 2027-03-01
• Primary completion: 2029-08-28
• Completion: 2029-08-28
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States