Clinical trial NCT04874077: Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder
Official title: Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Voice biomarkers
Speech analysis
Lead sponsor: Kintsugi Mindful Wellness, Inc.
Sponsor class: INDUSTRY
Collaborators: name: San Francisco Psychiatry Group
name: Frontier Psychiatry
First posted: 2021-05-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of the Kintsugi's technology's prediction
timeFrame: July 30, 2021
Secondary outcomes:
measure: Sensitivity and specificity to depression at the PHQ-9 score of 10
timeFrame: July 30, 2021
measure: Sensitivity and specificity to depression at the GAD-7 score of 10
timeFrame: July 30, 2021
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Psychiatrists, Inc.
state: California
city: Billings
country: United States
facility: Frontier Psychiatry
state: Montana
Study officials:
References: