DepressionSpeech2NCT00844948
Vocal Acoustic Biomarkers in Depression
An observational study of Depression, run by Center for Psychological Research, Madison, WI at 2 sites in United States.
Trial summary
This Phase II SBIR study will replicate pilot study methods establishing computer-automated methods for assessing depression severity using interactive voice response system technology and demonstrating feasibility of obtaining measures of depression severity and treatment response through vocal acoustic analysis of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Apr 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: English speaking: Young Adults, age 18-25; Elderly, age 60-80. Chinese speaking (Mandarin or Cantonese): age 18-80.
Who may be able to join
- Age 18 - 80.
- Written informed consent.
- Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
- Recently started to receive or about to start receiving treatment for MDD
- Quick Inventory of Depressive Symptomatology - Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit.
Who cannot join
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months.
- History or current diagnosis of dementia.
- Diagnosis or history of hypothyroidism.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Cove Community Health
Boston, Massachusetts, 02111
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, 02114
About this study
Official title: Development of a Convenient, Automated, Objective Measure of Depression
This Phase II SBIR study will replicate pilot study methods establishing computer-automated methods for assessing depression severity using interactive voice response system technology and demonstrating feasibility of obtaining measures of depression severity and treatment response through vocal acoustic analysis of speech samples obtained over the telephone. The study will automate vocal acoustic analysis methods, evaluate applicability to other patient populations (non-English speakers, children/young adult, and geriatric), and further develop multivariate acoustic models to enhance biomarker sensitivity to treatment response and prediction of the response likelihood for individual patients.
Read the detailed description
This study will incorporate IVR data collection procedures developed in a prior pilot study into a multi-site industry-sponsored Phase 4 randomized, double-blind, placebo-controlled study (NCT00406952) using an established antidepressant at a therapeutically efficacious dose. The analytic procedures used to extract the vocal acoustic measures will be automated to facilitate near rapid turn around between speech sample acquisition and delivery of biomarker outcomes data. Multivariate models of vocal acoustic information to enhance the sensitivity of treatment response measurement and prediction of patient response likelihood will be further refined.
A total of 150 subjects will be recruited in the proposed studies, a sample of 50 from each of three targeted depressed patient populations - young adults (18-25 years old), elderly patients (60 years and older), and recent Asian immigrants with financial, linguistic, and cultural barriers to health care access. Eligible subjects will meet diagnostic criteria for Major Depressive Disorder, provide written informed consent, and will have baseline depression severity scores of 10 or greater on the QIDS. Pregnant women, women of child bearing potential not using a medically accepted means of contraception, suicidal or homicidal patients, or those with unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, hematological disease, or with clinical or laboratory evidence of hypothyroidism will be excluded. Patients beginning a new treatment for depression will be clinically evaluated (QIDS-C) during face-to-face interviews at the beginning of treatment (Baseline), and followed up 4 (study midpoint) and 8 weeks later (end-point). After completing the clinical interviews study participants will complete a series of IVR-based assessments using a standard desktop touch-tone telephone.
- Conditions
- Depression
- Keywords
- Depression
- Medical subject headings
- Depression
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 |
|---|---|---|
| Young adults (18-25 years old) | Young adults (18-25 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. | |
| Elderly (60-80 years old) | Elderly (60-80 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. | |
| Chinese speakers | Chinese speakers (Mandarin or Cantonese). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motoric and frequency-based change in the vocal acoustic properties of speech associated with clinical improvement measured by the Quick Inventory of Depressive Symptomatology - IVR (QIDS-IVR).
Measured: baseline, week 4 & week 8
Secondary outcomes (1)
Multivariate logistic regression models of vocal acoustic properties optimized for sensitivity to treatment response and prediction of the response likelihood fitted to data obtained in NCT00407952.
Measured: baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Psychological Research, Madison, WI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Mundt, PhD, Principal investigator, Center for Psychological Research, Training and Consultation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844948
- Sponsor's protocol ID
- 2008P000110
- Other IDs
- 5R44MH068950-03
- Acronym
- Speech2
- Status last verified
- Apr 2012
- First submitted
- 13 Feb 2009
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Convenient, Automated, Objective Measure of Depression
- ClinicalTrials.gov ID
- NCT00844948
- Acronym / sponsor ID
- Speech2 / 2008P000110
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Center for Psychological Research, Madison, WIUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Feb 2009 (estimated)
- 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.
This Phase II SBIR study will replicate pilot study methods establishing computer-automated methods for assessing depression severity using interactive voice response system technology and demonstrating feasibility of obtaining measures of depression severity and treatment response through vocal acoustic analysis of speech samples obtained over the telephone. The study will automate vocal acoustic analysis methods, evaluate applicability to other patient populations (non-English speakers, children/young adult, and geriatric), and further develop multivariate acoustic models to enhance biomarker sensitivity to treatment response and prediction of the response likelihood for individual patients.
Detailed description
This study will incorporate IVR data collection procedures developed in a prior pilot study into a multi-site industry-sponsored Phase 4 randomized, double-blind, placebo-controlled study (NCT00406952) using an established antidepressant at a therapeutically efficacious dose. The analytic procedures used to extract the vocal acoustic measures will be automated to facilitate near rapid turn around between speech sample acquisition and delivery of biomarker outcomes data. Multivariate models of vocal acoustic information to enhance the sensitivity of treatment response measurement and prediction of patient response likelihood will be further refined.
A total of 150 subjects will be recruited in the proposed studies, a sample of 50 from each of three targeted depressed patient populations - young adults (18-25 years old), elderly patients (60 years and older), and recent Asian immigrants with financial, linguistic, and cultural barriers to health care access. Eligible subjects will meet diagnostic criteria for Major Depressive Disorder, provide written informed consent, and will have baseline depression severity scores of 10 or greater on the QIDS. Pregnant women, women of child bearing potential not using a medically accepted means of contraception, suicidal or homicidal patients, or those with unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, hematological disease, or with clinical or laboratory evidence of hypothyroidism will be excluded. Patients beginning a new treatment for depression will be clinically evaluated (QIDS-C) during face-to-face interviews at the beginning of treatment (Baseline), and followed up 4 (study midpoint) and 8 weeks later (end-point). After completing the clinical interviews study participants will complete a series of IVR-based assessments using a standard desktop touch-tone telephone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young adults (18-25 years old) | – | –Young adults (18-25 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. |
| Elderly (60-80 years old) | – | –Elderly (60-80 years old). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started treatment or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. |
| Chinese speakers | – | –Chinese speakers (Mandarin or Cantonese). Major Depressive - eligible subjects will meet a baseline depression severity score of 10 or greater on the QIDS-C \& QIDS-IVR, will have recently started or about to start receiving treatment for MDD. Exclusion: subjects with suicidal ideation; subjects who have a history or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months; subjects with a history or current diagnosis of dementia or diagnosis or history of hypothyroidism. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- English speaking: Young Adults, age 18-25; Elderly, age 60-80. Chinese speaking (Mandarin or Cantonese): age 18-80.
Key inclusion criteria (5 listed)
- Age 18 - 80.
- Written informed consent.
- Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
- Recently started to receive or about to start receiving treatment for MDD
- Quick Inventory of Depressive Symptomatology - Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit.
Key exclusion criteria (4 listed)
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months.
- History or current diagnosis of dementia.
- Diagnosis or history of hypothyroidism.
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
Motoric and frequency-based change in the vocal acoustic properties of speech associated with clinical improvement measured by the Quick Inventory of Depressive Symptomatology - IVR (QIDS-IVR).
Time frame: baseline, week 4 & week 8
1 secondary outcome
Multivariate logistic regression models of vocal acoustic properties optimized for sensitivity to treatment response and prediction of the response likelihood fitted to data obtained in NCT00407952.
Time frame: baseline, week 4, week 8
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 7 May 2012.
Related trials for Depression
Active, not recruiting
Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
Suicide and Depression, Adolescent Behavior
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Depression, Anxiety, Psilocybin-Assisted Psychotherapy
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
RecruitingPhase 2
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
Depression, Anxiety
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.
James C Mundt, PhD principal investigator
Center for Psychological Research, Training and Consultation
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 Depression, run by Center for Psychological Research, Madison, WI 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 5 inclusion and 4 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 7 May 2012. 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?
Motoric and frequency-based change in the vocal acoustic properties of speech associated with clinical improvement measured by the Quick Inventory of Depressive Symptomatology - IVR (QIDS-IVR). (time frame: baseline, week 4 & week 8). 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 7 May 2012; AzTrials last refreshed its copy on 4 Nov 2026.