Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04874077

Enrollment

Registered

2021-05-05

Start date

2021-04-21

Completion date

2021-09-04

Last updated

2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Voice biomarkers, Speech analysis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

United States

Outcome results