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NCT06923995: SEQUOIA-1
Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
NA trial testing AI-driven clinical interview in Depression Disorders in 120 participants. Currently enrolling.
28 February 2026
Quick facts
| Lead sponsor | Deliberate Solutions Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 120 |
| Start date | 1 September 2025 |
| Primary completion | 28 February 2026 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AI-driven clinical interview
Conditions studied
- Depression Disorders — all drugs for Depression Disorders →
- Anxiety Disorders — all drugs for Anxiety Disorders →
Sponsor
Deliberate Solutions Inc.
Who can join
Adults 18 to 65, any sex, with Depression Disorders or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 with the AI interviewer. All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians. The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06923995
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Other Deliberate Solutions Inc. trials
Trials by the same sponsor.
- NCT07279038 — Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety · not yet recruiting
- NCT07279025 — Validate the Temporal Stability and Responsiveness of AI-COA® for Depression and Anxiety · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06923995 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Deliberate Solutions Inc.
- Last refreshed: 13 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06923995.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing