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

NCT07279038 | Not Yet Recruiting

• 1 other identifier: SEQUOIA-3
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression Disorders; Anxiety Disorders

Keywords

depression assessment; anxiety assessment

Outcome Measures

Primary Outcomes (1)

• HAM-D ICC

  Concordance of HAM-D score between model and human raters

  Baseline

Secondary Outcomes (2)

• MADRS ICC

  Baseline

• HAM-A ICC

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with MDD or MDE

You may qualify if:

• English fluency
• to 65 years of age.
• Diagnosed with MDD or MDE (Includes Remission, HAM-D \<= 7)
• Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment
• Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Resides in the United States at the time of consent and during completion of study

You may not qualify if:

• Any cognitive impairment that limits ability to provide informed consent or authorization
• Vulnerable or protected populations (e.g. prisoners)
• Impairment that would prevent participants from completing an online survey and/or engaging in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment)
• Acute intoxication at the time of the assessments
• Concurrent medication/treatment:
• Receiving any fast-acting treatment for depression or anxiety (e.g. ketamine, psychedelics, deep brain stimulation, etc.) in between initial baseline assessment (A1) and Restest (A2) , or in between Follow up assessment (B1) and Retest (B2)
• Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.
• Antipsychotics and Mood Stabilizers: Medications that can alter cognitive and motor functions, within the past 6 weeks.
• Stimulants: Use of medications like methylphenidate or amphetamines that affect energy levels and behavior, within the past 2 weeks
• Epilepsy medication: seizure activity or medication side effects that may alter behavior, within the past 4 weeks.
• Any history or evidence of any of the following conditions:
• Neurodevelopmental, Neurocognitive, Neurodegenerative or movement disorders including, but not limited to:
• Tourette's syndrome
• Multiple Sclerosis
• Amyotrophic Lateral Sclerosis

Sponsors & Collaborators

• Deliberate Solutions Inc.: lead
• Baylor College of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

audiovideo recordings

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marc Aafjes

  Deliberate Solutions Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Storch, PhD

CONTACT

713-798-3579; research@sequoiastudy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 12, 2025
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): August 28, 2029
• Study Completion (Estimated): August 28, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)