Deliberate Solutions Inc.
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.
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 ethnicit…
Inclusion Criteria: * English fluency * 18 to 65 years of age. * Diagnosed with MDD or MDE (Includes Remission, HAM-D \<= 7) * Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment * Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection * Stated willingness to comply with all study procedures and availability for the duration of the study * Resides in the United States at the time of consent and during completion of study Exclusion Criteria: * Any cognitive impairment that limits abil…
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