Status:
COMPLETED
Vocal Acoustic Biomarkers in Depression
Lead Sponsor:
Center for Psychological Research, Madison, WI
Collaborating Sponsors:
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Brief 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 demonstrati...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00844948
Start Date
October 1 2008
End Date
April 1 2012
Last Update
May 7 2012
Active Locations (2)
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1
South Cove Community Health
Boston, Massachusetts, United States, 02111
2
Massachusetts General Hospital Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114