Depression DisordersSEQUOIA-3NCT07279038
Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety
An observational study of Depression Disorders and Anxiety Disorders, run by Deliberate Solutions Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorders, Anxiety Disorders
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 28 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with MDD or MDE
Who may be able to join
- English fluency
- 18 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
Who cannot join
- 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)
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- 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
- Parkinson's Disease
- Stroke
- Traumatic Brain Injury
- Facial paralysis.
- Conditions with vocal cord impact:
- Vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
- Disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
- Past or active heavy smokers (an average of >20 cigarettes per day)
- Schizophrenia Spectrum and Other Psychotic Disorders:
- Individuals with a current or past diagnosis of Schizophrenia, Schizoaffective Disorder, or other psychotic disorders, including Delusional Disorder and Brief Psychotic Disorder.
- Current hypomanic episode as defined by DSM-5 criteria. This includes those with Bipolar I Disorder, Bipolar II Disorder, or Cyclothymic Disorder who are not in a stable mood state at the time of assessment.
- Chronic Pain Conditions: Such as fibromyalgia, which may affect facial expressions and vocal tone.
- Prosthetic Facial Devices: Could affect facial recognition algorithms. Cosmetic Procedures: Such as Botox injections or facelifts that can impact facial expressions.
- Dental Work: Major procedures that might affect speech.
- Participants who have previously participated in another research project by Deliberate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase
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.
Read the detailed description
The SEQUOIA-3 study is a Comprehensive U.S. Clinical Validation of the AI-generated Clinical Outcome Assessment (AI-COA®) for depression and anxiety. This observational study supports the clinical validation of a digital tool intended to measure depression severity using audiovisual data from clinical interviews. The study builds on previous research to establish the tool's validity for regulatory qualification.
Key elements of the study include:
Diverse Enrollment: The study will prospectively enroll a large, stratified sample to ensure adequate representation across sex, race, and ethnicity, as well as a full range of symptom severity (from remission to severe).
Validation: The software's severity scores will be compared against a "ground truth" standard derived from the consensus of independent human raters.
Remote Assessment: Participants will complete standard clinical interviews and self-report measures via secure video conferencing.
The results will be used to demonstrate the tool's generalizability and its ability to provide unbiased assessments across different patient populations.
- Conditions
- Depression Disorders, Anxiety Disorders
- Keywords
- depression assessment, anxiety assessment
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D ICC
Concordance of HAM-D score between model and human raters
Measured: Baseline
Secondary outcomes (2)
MADRS ICC
Concordance of MADRS score between model and human raters
Measured: Baseline
HAM-A ICC
Concordance of HAM-A score between model and human raters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Mar 2027 (estimated)
- Primary completion28 Aug 2029 (estimated)
- Study completion28 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deliberate Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Aafjes, Principal investigator, Deliberate Solutions Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279038
- Sponsor's protocol ID
- SEQUOIA-3
- Acronym
- SEQUOIA-3
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase
- ClinicalTrials.gov ID
- NCT07279038
- Acronym / sponsor ID
- SEQUOIA-3 / SEQUOIA-3
- Conditions
- Depression Disorders, Anxiety Disorders
- Keywords
- depression assessment, anxiety assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Deliberate Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 28 Aug 2029 (estimated)
- Study completion
- 28 Aug 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SEQUOIA-3 study is a Comprehensive U.S. Clinical Validation of the AI-generated Clinical Outcome Assessment (AI-COA®) for depression and anxiety. This observational study supports the clinical validation of a digital tool intended to measure depression severity using audiovisual data from clinical interviews. The study builds on previous research to establish the tool's validity for regulatory qualification.
Key elements of the study include:
Diverse Enrollment: The study will prospectively enroll a large, stratified sample to ensure adequate representation across sex, race, and ethnicity, as well as a full range of symptom severity (from remission to severe).
Validation: The software's severity scores will be compared against a "ground truth" standard derived from the consensus of independent human raters.
Remote Assessment: Participants will complete standard clinical interviews and self-report measures via secure video conferencing.
The results will be used to demonstrate the tool's generalizability and its ability to provide unbiased assessments across different patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with MDD or MDE
Key inclusion criteria (7 listed)
- English fluency
- 18 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
Key exclusion criteria (30 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HAM-D ICC
Time frame: Baseline
Concordance of HAM-D score between model and human raters
2 secondary outcomes
MADRS ICC
Time frame: Baseline
HAM-A ICC
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Aafjes principal investigator
Deliberate Solutions Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Disorders and Anxiety Disorders, run by Deliberate Solutions Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Storch, PhD (713-798-3579, research@sequoiastudy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D ICC (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.