Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

Study Overview
=================
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.

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

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br> | |
| Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the Kintsugi's technology's prediction | Sensitivity and specificity of the Kintsugi's technology's prediction compared to HAM-D and HAM-A scores. | July 30, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity to depression at the PHQ-9 score of 10 | Sensitivity and specificity of the Kintsugi's technology's prediction compared to PHQ-9 scores at a cutoff threshold of 10 | July 30, 2021 | 
| Sensitivity and specificity to depression at the GAD-7 score of 10 | Sensitivity and specificity of the Kintsugi's technology's prediction compared to GAD-7 scores at a cutoff threshold of 10 | July 30, 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voice biomarkers, Speech analysis