Kintsugi Voice Device Pivotal Study
Recruiting
Observational Study
Depression
Depression Moderate
Depression Severe
Depression Mild
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Kintsugi Mindful Wellness, Inc. · Industry
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About This Trial
A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Age \>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exerci…
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