Dichotic Listening as a Predictor of 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.
Depressive Disorder NOS
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dichotic Listening as a Predictor of Placebo and Medication Response in Depression|
- Hamilton Depression Scale (HAM-D) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
- Clinical Global Impression Scale (CGI) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
- Atypical Depression Diagnostic Scale (ADDS) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
- Deragotis Sexual Performance Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
- Snaith-Hamilton Pleasure Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
- Spielberger State/Trait Anxiety Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
|Study Start Date:||April 1994|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Other Name: Prozac
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.
Other Name: Tofranil
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.
|United States, New York|
|Depression Evaluation Service, New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Jonathan W. Stewart, MD.||New York State Psychiatric Institute - Columbia University Department of Psychiatry|