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

Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This observational study supports the clinical validation of a digital tool intended to measure depression severity using audiovisual data from clinical interviews."
  • "Remote Assessment: Participants will complete standard clinical interviews and self-report measures via secure video conferencing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how accurate and reliable the AI-COA® software tool is in adults with major depression. It checks whether the tool works fairly across people from different backgrounds.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English fluently and be 18 to 65 years old.
  • Have major depressive disorder (MDD) or a major depressive episode (MDE). People whose symptoms have eased or gone away may also qualify.
  • Be starting, or have started, a new treatment for depression or anxiety within 2–3 weeks of joining.
  • Have a computer with a working microphone and webcam, plus a stable internet connection.
  • Be willing to follow all study steps and be available for the full study.
  • Live in the United States when giving consent and throughout the study.

Who can't join

  • Have thinking or memory problems that prevent informed consent, or belong to a protected or vulnerable group, such as prisoners.
  • Have vision, hearing, movement, or other problems that prevent online surveys or interviews with a clinician; or be drunk or high during assessments.
  • Receive fast-acting depression or anxiety treatments, such as ketamine, psychedelics, or deep brain stimulation, between either assessment and its repeat test.
  • Use certain medicines that affect speech, movement, thinking, energy, or behavior: anxiety medicines within 4 weeks; antipsychotics or mood stabilizers within 6 weeks; or stimulants within 2 weeks. Seizures or seizure medicine side effects that affect behavior within 4 weeks also exclude you.
  • Have a past or current brain, nerve, development, memory, or movement disorder. Examples include Tourette's, multiple sclerosis, ALS, Parkinson's, stroke, brain injury, or facial paralysis.
  • Have conditions that affect the vocal cords, or a vocal cord injury, stroke, or head injury with lasting unclear speech in the past year. Current or past heavy smoking—more than 20 cigarettes a day on average—also excludes you.
  • Have a past or current psychotic disorder, such as schizophrenia, which can affect what seems real; or a current hypomanic episode, meaning unusually high energy or mood. Chronic pain, artificial facial devices, cosmetic treatments that affect facial expressions, or major dental work that may affect speech also exclude you.
  • Have taken part in another research project by Deliberate.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Study sites (1)

TX