Official Title: “Dichotic Listening as a Predictor of Placebo and Medication Response in Depression”

Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine and Placebo) until remitted, to see whether test results predict specific outcomes.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study

Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during six weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning, and do not show an advantage of drug over placebo. 100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Placebo, Fluoxetine and Imipramine until remitted.

Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.
• Drug: Imipramine
  • wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated.

Primary Measures

• Hamilton Depression Scale (HAM-D)
  • Time Frame: 6 mos.
    Safety Issue?: No
• Fuse Words Test
  • Time Frame: 6 mos.
    Safety Issue?: No
• Nonsense Syllables Test
  • Time Frame: 6 mos.
    Safety Issue?: No
• Complex Tones Test
  • Time Frame: 6 mos.
    Safety Issue?: No

Secondary Measures

• Clinical Global Impression Scale (CGI)
  • Time Frame: 6 mos.
    Safety Issue?: No
• Atypical Depression Diagnostic Scale (ADDS)
  • Time Frame: 6 mos.
    Safety Issue?: No
• Deragotis Sexual Performance Scale
  • Time Frame: 6 mos.
    Safety Issue?: No
• Snaith-Hamilton Pleasure Scale
  • Time Frame: 6 mos.
    Safety Issue?: No
• Spielberger State/Trait Anxiety Scale
  • Time Frame: 6 mos.
    Safety Issue?: No

Inclusion Criteria:

• Ages between 18-65
• Meets DSM-IV criteria for current Major Depression, Dysthymia or Depression NOS

Exclusion Criteria:

• Known hearing impairment
• Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis)
• HAMD > 20
• Current (past six months) alcohol and/or drug abuse or dependence
• Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
• Bipolar I
• Psychosis
• If currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for Prozac) or felt to require other psychiatric medication (other than occasional sleep or Anxiety medication)
• Premenopausal women not using known effective birth control
• Not currently depressed (whether considered due to current treatment or not)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: New York State Psychiatric Institute

Overall Clinical Trial Officials and Contacts

Jonathan W. Stewart, MD. Principal Investigator New York State Psychiatric Institute - Columbia University Department of Psychiatry  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296725

Study ID Number: IRB4217R

ClinicalTrials.gov Identifier: NCT00296725

Health Authority: United States: Institutional Review Board

Depression Evaluation Service - official website

New York State Psychiatric Institute - official website