Vocal Acoustic Biomarkers in Depression (Speech2)

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Center for Psychological Research, Madison, WI
ClinicalTrials.gov Identifier:
NCT00844948
First received: February 13, 2009
Last updated: May 4, 2012
Last verified: April 2012
  Purpose

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.


Condition
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Convenient, Automated, Objective Measure of Depression

Further study details as provided by Center for Psychological Research, Madison, WI:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 125
Study Start Date: October 2008
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

English speaking: Young Adults, age 18-25; Elderly, age 60-80. Chinese speaking (Mandarin or Cantonese): age 18-80.

Criteria

Inclusion Criteria:

  1. Age 18 - 80.
  2. Written informed consent.
  3. Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
  4. Recently started to receive or about to start receiving treatment for MDD
  5. Quick Inventory of Depressive Symptomatology - Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit.

Exclusion Criteria:

  1. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
  2. 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.
  3. History or current diagnosis of dementia.
  4. Diagnosis or history of hypothyroidism.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844948

Locations
United States, Massachusetts
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114
South Cove Community Health
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Center for Psychological Research, Madison, WI
Massachusetts General Hospital
Investigators
Principal Investigator: James C Mundt, PhD Center for Psychological Research, Training and Consultation
  More Information

No publications provided

Responsible Party: Center for Psychological Research, Madison, WI
ClinicalTrials.gov Identifier: NCT00844948     History of Changes
Other Study ID Numbers: 2008P000110, 5R44MH068950-03
Study First Received: February 13, 2009
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Psychological Research, Madison, WI:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014