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NCT06374056 · ClinicalTrials.gov registry record
Kintsugi Voice Device Pilot Study
A clinical trial of Depression and Depression Mild, sponsored by Kintsugi Mindful Wellness.
- Active
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT06374056: Active study of Depression and Depression Mild, sponsored by Kintsugi Mindful Wellness.
NCT06374056 is a study of Depression and Depression Mild that is active but no longer recruiting, run by Kintsugi Mindful Wellness. The registered enrollment target is 500 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06374056, a study of Depression and Depression Mild, is active but no longer recruiting, sponsored by Kintsugi Mindful Wellness.
- ACTIVE NOT RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
A prospective, single arm, non-randomized, pilot 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-CT) for up to 500 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
Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using sensitivity and specificity.
Conditions Studied
Interventions
- DEVICE Kintsugi Voice Device
Study Locations (1)
California
- Kintsugi Mindful Wellness Inc. - Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-03-22 |
| Est. Completion | 2025-07-22 |
What the registry record for NCT06374056 still lists
NCT06374056 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (36% lower).
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.
NCT06374056 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06374056 about?
NCT06374056 is a clinical study titled "Kintsugi Voice Device Pilot Study". A prospective, single arm, non-randomized, pilot 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-...
What is the current status of trial NCT06374056?
This trial is currently active not recruiting. The enrollment target is 500 participants. The study started on 2024-03-22. Estimated completion is 2025-07-22.
What conditions does trial NCT06374056 study?
This clinical trial studies the following conditions: Depression, Depression Mild, Depression Moderate, Depression Severe.
What interventions are being tested in trial NCT06374056?
The interventions under investigation include: Kintsugi Voice Device (DEVICE).
Who is sponsoring clinical trial NCT06374056?
This trial is sponsored by Kintsugi Mindful Wellness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06374056 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 NCT06374056's enrollment target sits among peer trials
500 79th of 679 higher than 592 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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