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Your voice may hold clues to depression – a new device listens in

NCT ID NCT06374056

Diagnosis Sponsor: Kintsugi Mindful Wellness, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study tests a voice-analysis device designed to help clinicians screen for moderate to severe depression. Adults aged 22 and older will record their voice, and the device's assessment will be compared to a standard clinical interview. The goal is to see if the device can accurately identify signs of depression based on voice patterns, potentially offering a faster, more objective screening method.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kintsugi Voice Device - a software-based device that analyzes voice recordings to screen for signs of moderate to severe depression.
What this could lead to
If successful, this could provide a quick, objective screening tool to help clinicians identify depression earlier and more accurately.
What could go wrong
This is an early pilot study, so the device may not prove accurate enough for real-world use. Voice-based screening is experimental and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

262 people

The number who actually took part.

Started

Mar 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll up to 500 English speaking subjects \>22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Depression mild Depression moderate Depression severe

Contacts and locations

Locations

  • Kintsugi Mindful Wellness Inc.

    Berkeley, California, 94707, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.