Major Depressive DisorderNCT04874077
Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Kintsugi Mindful Wellness, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2021to 4 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Frontier Psychiatry
Billings, Montana, 59101
San Francisco Psychiatrists, Inc.
San Francisco, California, 94123
About this study
Official title: Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study
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.
Read more
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
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: July 30, 2021
Secondary outcomes (2)
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
Measured: 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
Measured: July 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start21 Apr 2021
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Francisco Psychiatry Group, Frontier Psychiatry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874077
- Sponsor's protocol ID
- 2021/03/20
- Status last verified
- Jun 2022
- First submitted
- 30 Apr 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder: A Multi-Site Fully Remote E-Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04874077
- Acronym / sponsor ID
- 2021/03/20
- Conditions
- Major Depressive Disorder
- Keywords
- Voice biomarkers, Speech analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.Industry (pharma, biotech, devices)
- Collaborators
- San Francisco Psychiatry Group, Frontier Psychiatry
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Sensitivity and specificity to depression at the PHQ-9 score of 10
Time frame: July 30, 2021
Sensitivity and specificity to depression at the GAD-7 score of 10
Time frame: July 30, 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Kintsugi Mindful Wellness, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the Kintsugi's technology's prediction (time frame: July 30, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.