Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder

NCT04874077 | Completed

• 1 other identifier: 2021/03/20
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

Voice biomarkers; Speech analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity and specificity to depression at the PHQ-9 score of 10

  July 30, 2021

• Sensitivity and specificity to depression at the GAD-7 score of 10

  July 30, 2021

Study Arms (2)

Case

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kintsugi Mindful Wellness, Inc.: lead
• San Francisco Psychiatry Group: collaborator
• Frontier Psychiatry: collaborator

Study Sites (2)

San Francisco Psychiatrists, Inc.

San Francisco, California, 94123, United States

Location

Frontier Psychiatry

Billings, Montana, 59101, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: April 21, 2021
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

US (2)