AI-clinical outcome assessment (AI-COA) for depression: an innovative drug development tool - depression is a major public health issue affecting hundreds of millions globally, with significant…

The National Institute of Mental Health awarded $1,415,720 to Deliberate Solutions Inc. on August 5, 2026, under the Mental Health Research Grants program (CFDA 93.242) to advance AI-CLINICAL OUTCOME ASSESSMENT (AI-COA) for Depression toward regulatory qualification and commercial readiness as a drug development tool.

The project funds technical development and clinical validation of AI-COA, a multimodal artificial intelligence tool designed to provide objective, standardized assessment of depression severity in clinical trials. The tool addresses limitations of current FDA-approved scales—the Hamilton (HAM-D) and Montgomery and Asberg (MADRS) depression rating scales—which rely on subjective measurement and lack standardization, contributing to high failure rates in Phase 3 depression trials. AI-COA uses computational methods to objectively measure multimodal features of depression severity and has demonstrated high concurrent reliability with HAM-D scores. The FDA has accepted AI-COA into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program, designating it as the first AI and digital health technology and the inaugural neuroscience project in the program.

Performance occurs in New York through July 31, 2027. This SBIR Phase II award enables AI-COA to progress toward FDA qualification as a drug development tool, supporting more precise and reliable depression assessments in clinical trials and advancing development of more effective depression treatments.

AI-clinical outcome assessment (AI-COA) for depression: an innovative drug development tool - depression is a major public health issue affecting hundreds of millions globally, with significant implications for suicide risk and overall health. Reliable assessment of depression severity is crucial for the development and validation of new medications, yet the current FDA-approved scales, the hamilton (HAM-D) and montgomery and åsberg (MADRS) depression rating scales, are limited by their subjective nature and lack of standardization. These limitations introduce measurement error and contribute to the particularly high failure rate of phase 3 clinical trials in depression. The depression aicoa®, a novel multimodal AI-based tool, has been developed to address these challenges by providing a more reliable and standardized method for assessing depression severity. Utilizing a computational approach that objectively measures multimodal features of depression severity, aicoa® has shown high concurrent reliability with HAM-D scores. Recognizing its potential, the FDA has recently accepted aicoa® into its innovative science and technology approaches for new drugs (ISTAND) pilot program, marking IT as the first AI and digital health technology, as well as the inaugural neuroscience project in the program. This sbir project aims to advance aicoa® to regulatory qualification and a commercially ready stage through extensive clinical validation. The project will support the technical development and clinical validation of aicoa® through a comprehensive study. The outcomes of this research will enable aicoa® to progress with FDA qualification as a drug development tool, paving the way for more precise and reliable depression assessments in clinical trials, ultimately leading to the development of more effective treatments.