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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 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.

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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

Interventions

  • OTHER AI-driven clinical interview

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-09-01
Est. Completion 2026-02-28
Phase NA

Sponsor

Deliberate Solutions

3 total trials

What the Registry Record Tells You About NCT06923995

The ClinicalTrials.gov registry entry for NCT06923995 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,139-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (89% lower). The listed sponsor is Deliberate Solutions, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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