Deliberate Solutions Inc., Baylor College of Medicine, and the National Institute of Mental Health (NIMH), in collaboration, have announced plans to initiate a key U.S. clinical validation study evaluating AI-COA®, an artificial intelligence system designed for assessing depression and anxiety. This groundbreaking research is set to bring critical insights that could reshape mental health care delivery for these conditions.
As of December 2025, the trial is listed as “Not yet recruiting” on ClinicalTrials.gov. The announcement marks an important step for clinical, regulatory, and quality stakeholders monitoring the evolution of AI-based medical devices in behavioral health.
In this article
- What is AI-COA®?
- Clinical trial objectives
- Who is involved?
- Impact on the regulatory landscape
- FAQ
- Conclusion and next steps
- Disclaimer
- Full announcement details
What is AI-COA®?
AI-COA® is an advanced artificial intelligence-driven tool aimed at enhancing the assessment of depression and anxiety disorders. The system integrates computational algorithms to analyze clinical outcomes and patient-reported data.
The intended purpose of AI-COA® is to deliver clinicians evidence-based measures to support better therapeutic decision-making. The device prioritizes safety, performance accuracy, and real-world usability. Given its focus on mental health conditions, AI-COA® aligns with growing policy and clinical trends emphasizing personalized and validated care solutions.
Clinical trial objectives
The pivotal trial aims to validate the accuracy, reliability, and safety of AI-COA® under real-world clinical conditions in the U.S. The study intends to enroll participants diagnosed with depression or anxiety disorders to compare system performance against standard assessment methods.
This validation is an essential requirement for potential regulatory approvals. Stakeholders in clinical development and quality assurance will closely watch to understand how AI-COA® meets relevant performance and compliance criteria.
Who is involved?
The study is sponsored by Deliberate Solutions Inc., an organization specializing in innovative healthcare solutions.
Baylor College of Medicine is contributing its expertise in clinical research and protocol development. Additionally, the National Institute of Mental Health (NIMH)—a leading institution in mental health advancement—supports the initiative, signaling a high level of confidence in the study’s design and potential outcomes.
Impact on the regulatory landscape
If successful, this clinical validation could provide a strong case for AI-COA® as a tool in assessing mental health conditions. The outcome holds significance for medical device developers expanding into AI use cases, offering a roadmap for regulatory compliance in artificial intelligence technologies.
FDA involvement in the approval processes for AI-based devices is continuously evolving. This trial’s compliance with U.S. regulatory standards may help solidify best practices for future mental health technologies.
FAQ
- What is the current study status? As of December 2025, the study is listed as “Not yet recruiting.”
- Which organizations are supporting this trial? Sponsors include Deliberate Solutions Inc., Baylor College of Medicine, and the National Institute of Mental Health (NIMH).
- Where can I find more details? The trial details are available on ClinicalTrials.gov under study ID NCT07279038.
Conclusion and next steps
The clinical validation of AI-COA® represents a pivotal development in mental health care innovation. For stakeholders across the regulatory and clinical spectrum, this trial could establish a benchmark for AI applications in the diagnosis and management of depression and anxiety disorders.
With recruitment expected to begin soon, regulatory and quality professionals should follow this study closely to evaluate its findings and potential implications for future medical device approvals.
Disclaimer
This article provides general information intended for medical and regulatory professionals. It does not constitute legal or regulatory advice. Please consult relevant authorities for official guidance.
Full announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07279038?term=medical+device