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NCT06923995 · ClinicalTrials.gov registry record · NA
Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity
A NA study of Anxiety Disorders and Depression Disorders, sponsored by Deliberate Solutions.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06923995: Recruiting NA study of Anxiety Disorders and Depression Disorders, sponsored by Deliberate Solutions.
NCT06923995 is a NA study of Anxiety Disorders and Depression Disorders that is actively recruiting participants, run by Deliberate Solutions. The registered enrollment target is 120 participants, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06923995, a NA study of Anxiety Disorders and Depression Disorders, is actively recruiting participants, sponsored by Deliberate Solutions.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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 anx
Primary Outcome
Concordance of HAM-D score between model and human raters
Conditions Studied
Interventions
- OTHER AI-driven clinical interview
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
What NCT06923995 shows while recruiting
NCT06923995 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 1 intervention - of which AI-driven clinical interview is the first listed.
NCT06923995 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06923995 about?
NCT06923995 is a clinical study titled "Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity". 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 assessm...
What is the current status of trial NCT06923995?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-09-01. Estimated completion is 2026-02-28.
What conditions does trial NCT06923995 study?
This clinical trial studies the following conditions: Anxiety Disorders, Depression Disorders.
What interventions are being tested in trial NCT06923995?
The interventions under investigation include: AI-driven clinical interview (OTHER).
Who is sponsoring clinical trial NCT06923995?
This trial is sponsored by Deliberate Solutions, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06923995 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06923995's enrollment target sits among peer trials
120 39th of 84 higher than 45 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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