Vocal Acoustic Biomarkers in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

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 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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Depression