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Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT04874077
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
San Francisco Psychiatry Group
Frontier Psychiatry
Information provided by (Responsible Party):
Kintsugi Mindful Wellness, Inc.

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
Major Depressive Disorder

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Study Type : Observational
Estimated Enrollment : 225 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 : April 21, 2021
Estimated Primary Completion Date : June 21, 2021
Estimated Study Completion Date : July 21, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Case
Control



Primary Outcome Measures :
  1. Sensitivity and specificity of the Kintsugi's technology's prediction [ Time Frame: July 30, 2021 ]
    Sensitivity and specificity of the Kintsugi's technology's prediction compared to DSM-5 diagnosis of depression.


Secondary Outcome Measures :
  1. Sensitivity and specificity to depression at the PHQ-9 score of 10 [ Time Frame: 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 [ Time Frame: July 30, 2021 ]
    Sensitivity and specificity of the Kintsugi's technology's prediction compared to GAD-7 scores at a cutoff threshold of 10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This study will enroll 225 men and women over the age of 18. 150 depressed participants will be recruited via an email from their treating psychiatrists. The researchers are collaborating with 2 psychiatric practices to recruit patients from.

75 non-depressed participants will be recruited from the general population via Craigslist ads. Participants will go through a clinical evaluation with a mental health professional to rule out current episode of depression.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874077


Contacts
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Contact: Grace Chang (415) 754-9129 grace@kintsugihello.com

Locations
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United States, California
San Francisco Psychiatrists, Inc. Recruiting
San Francisco, California, United States, 94123
Contact: Girish Subramanyan, MD         
United States, Montana
Frontier Psychiatry Not yet recruiting
Billings, Montana, United States, 59101
Contact: Reza Hosseini Ghomi, MD         
Sponsors and Collaborators
Kintsugi Mindful Wellness, Inc.
San Francisco Psychiatry Group
Frontier Psychiatry
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Responsible Party: Kintsugi Mindful Wellness, Inc.
ClinicalTrials.gov Identifier: NCT04874077    
Other Study ID Numbers: 2021/03/20
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021

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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:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms