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Study identifier: NCT06809907 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Kintsugi Voice Device Pivotal Study

Condition: Depression · Depression Moderate · Depression Severe  ·  Sponsor: Kintsugi Mindful Wellness, Inc.

PhaseN/A
Planned participants1000
Who can joinAll sexes, 22 Years to no upper limit
Healthy volunteersYes

About this study

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. Recruitment will occur for 1 year and participation will be for up to 2 weeks

This description comes directly from the study's public registry record.

Talk to the study team

Dr. Kolby Walker D.O.  ·  (209) 662-5369  ·  Kolby.Walker@vituity.com

Always discuss trial participation with your own doctor first.

Locations (1)

Kintsugi (Decentralized, Virtual Study)Berkeley, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06809907