Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity

The SEQUOIA-1 study evaluates the effectiveness of Artificial Intelligence (AI) in measuring depression and anxiety severity in adults. Investigators from Deliberate Solutions, Inc. and Baylor College of Medicine are conducting this study to determine whether AI can provide reliable clinical assessments of mood and anxiety disorders. In clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings. To address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. The primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments. During the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer. All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians. The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.

NCT Number	NCT06923995
Lead Sponsor	Deliberate Solutions Inc. Collaborators: Baylor College of Medicine
Conditions	Depression Disorders, Anxiety Disorders
Enrollment	120 participants
Start Date	2025-09-01
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-11-13