🏛️ Verified NIH Record • Updated 2025-12-07

Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety (NCT07279038)

Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase

🟡 Not Yet Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Deliberate Solutions Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Baylor College of Medicine — Houston, Texas

Age range: 18 Years to 65 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (1 Sites)

  • Baylor College of Medicine — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 798-3579

Email: research@sequoiastudy.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗