Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco Psychiatrists, Inc., San Francisco, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 HAM-D and HAM-A scores.

Secondary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Kintsugi Mindful Wellness, Inc.

Industry

Collaborators

Frontier Psychiatry
San Francisco Psychiatry Group

Registry information

Official study title

Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: May 5, 2021
Registry last updated: Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed