Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorDeliberate Solutions Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
patients with MDD or MDE
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
HAM-D ICC
Concordance of HAM-D score between model and human raters
Time frame
BaselineSecondary outcomes
1
MADRS ICC
Concordance of MADRS score between model and human raters
Time frame
Baseline2
HAM-A ICC
Concordance of HAM-A score between model and human raters
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Deliberate Solutions Inc.
Lead sponsor
Baylor College of Medicine
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: