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NCT06809907 · ClinicalTrials.gov registry record
Kintsugi Voice Device Pivotal Study
A clinical trial of Depression and Depression Mild, sponsored by Kintsugi Mindful Wellness.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT06809907: Recruiting study of Depression and Depression Mild, sponsored by Kintsugi Mindful Wellness.
NCT06809907 is a study of Depression and Depression Mild that is actively recruiting participants, run by Kintsugi Mindful Wellness. The registered enrollment target is 1,000 participants, above the 785-participant average among 679 other Depression trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06809907, a study of Depression and Depression Mild, is actively recruiting participants, sponsored by Kintsugi Mindful Wellness.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Achieve a composite lower bound of sensitivity greater than or equal to 70% and specificity greater than or equal to 70% for the KV Device relative to the high diagnostic confidence clinical reference standard as defined in Section 7.4.1 for which the device provides a result
Conditions Studied
Interventions
- DEVICE Kintsugi Voice Device
Study Locations (1)
California
- Kintsugi (Decentralized, Virtual Study) - Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2025-11 |
What NCT06809907 shows while recruiting
NCT06809907 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 785-participant average among 679 other Depression trials with a reported enrollment target (27% higher).
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Kintsugi Voice Device is the first listed.
NCT06809907 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06809907 about?
NCT06809907 is a clinical study titled "Kintsugi Voice Device Pivotal 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 (SCI...
What is the current status of trial NCT06809907?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2025-03-27. Estimated completion is 2025-11.
What conditions does trial NCT06809907 study?
This clinical trial studies the following conditions: Depression, Depression Mild, Depression Moderate, Depression Severe.
What interventions are being tested in trial NCT06809907?
The interventions under investigation include: Kintsugi Voice Device (DEVICE).
Who is sponsoring clinical trial NCT06809907?
This trial is sponsored by Kintsugi Mindful Wellness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06809907 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06809907's enrollment target sits among peer trials
1,000 37th of 679 higher than 639 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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