Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06374056
Eligibility Criteria:
Inclusion Criteria:
* Age \>22 at the time of informed consent
* Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet
* Stated willingness to be video and audio recorded as part of the study
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Fluency in English
* Availability for the duration of the study
* Resides in the United States at the time of consent and during completion of study
* Contributes to the approximately 50/50 depressed/healthy study population distribution
Exclusion Criteria:
* Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment)
* Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease)
* Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury
* Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia)
* Past or active heavy smokers (an average of \>20 cigarettes per day)
* Subjects who have previously participated in any Kintsugi-sponsored study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06374056
Study Brief:
Protocol Section:
NCT06374056