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Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

Sponsor
Kintsugi Mindful Wellness, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04874077
Collaborator
San Francisco Psychiatry Group (Other), Frontier Psychiatry (Other)
97
Enrollment
2
Locations
4.5
Actual Duration (Months)
48.5
Patients Per Site
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Major Depressive Disorder (MDD) is the leading cause of disability worldwide. Depression and anxiety disorders are among the most prevalent of all mental disorders, with an estimated annual prevalence of 9.7% and 18.1% respectively.

It has been known for the last 100 years that depression and anxiety both likely affect vocal acoustic properties. In 1921, Emil Kraepelin, characterized depressed patient's voices as having a lower pitch, lower volume, lower rate of speech, more monotony of prosody as well as more hesitations, stuttering, and whispering.

Mechanistically, it is possible that the neural circuitry involved in the pathophysiology of mood and anxiety disorders impinge upon the neural circuit involved in speech production, affecting qualities that include rate, prosody, speech latency and other paralinguistic features. Thus, acoustic features of speech may be one of the more readily accessible biomarkers for these conditions.

Given this understanding, the investigators sought to develop a passive vocal biomarker instrument for depression and anxiety screening that could markedly expand access as well as standardize the quality of screening in primary care settings.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study
    Actual Study Start Date :
    Apr 21, 2021
    Actual Primary Completion Date :
    Sep 4, 2021
    Actual Study Completion Date :
    Sep 4, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Case
    Control

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of the Kintsugi's technology's prediction [July 30, 2021]

      Sensitivity and specificity of the Kintsugi's technology's prediction compared to HAM-D and HAM-A scores.

    Secondary Outcome Measures

    1. Sensitivity and specificity to depression at the PHQ-9 score of 10 [July 30, 2021]

      Sensitivity and specificity of the Kintsugi's technology's prediction compared to PHQ-9 scores at a cutoff threshold of 10

    2. Sensitivity and specificity to depression at the GAD-7 score of 10 [July 30, 2021]

      Sensitivity and specificity of the Kintsugi's technology's prediction compared to GAD-7 scores at a cutoff threshold of 10

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult males and or females over the age of 18 at the time of informed consent

    • Access to a laptop, smartphone or tablet with a functioning microphone

    • Stated willingness to comply with all study procedures and availability for the duration of the study

    • Fluency in English

    • For depressed participant group: Current diagnosis of depression

    • For non-depressed participant group: No current or prior diagnosis of depression

    Exclusion Criteria:

    • Visual impairment that would make it difficult for the participant to follow the instructions

    • Motor impairment that would make it difficult for the participant to follow the instructions

    • Any known history of neurodegenerative or Central Nervous System disorders (e.g. MS, Dementia, TBI, Stroke, etc.)

    • Any known history of major psychiatric disorder other than depression (e.g. Bipolar Disorder, Schizophrenia, etc.)

    • Any known history of substance abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Francisco Psychiatrists, Inc. San Francisco California United States 94123
    2 Frontier Psychiatry Billings Montana United States 59101

    Sponsors and Collaborators

    • Kintsugi Mindful Wellness, Inc.
    • San Francisco Psychiatry Group
    • Frontier Psychiatry

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kintsugi Mindful Wellness, Inc.
    ClinicalTrials.gov Identifier:
    NCT04874077
    Other Study ID Numbers:
    • 2021/03/20
    First Posted:
    May 5, 2021
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Kintsugi Mindful Wellness, Inc.
    Voice biomarkers
    Speech analysis
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major

    Study Results

    No Results Posted as of Jul 6, 2022