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Study identifier: NCT06923995 Synced from ClinicalTrials.gov · August 05, 2026
● Recruiting

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

Condition: Depression Disorders · Anxiety Disorders  ·  Sponsor: Deliberate Solutions Inc.

PhaseNA
Planned participants120
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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 wi…

This description comes directly from the study's public registry record.

Talk to the study team

Eric Storch, PhD  ·  713-798-3579  ·  research@sequoiastudy.com

Always discuss trial participation with your own doctor first.

Locations (1)

Baylor College of MedicineHouston, Texas, United StatesRecruiting

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