Dichotic Listening as a Predictor of Medication Response in Depression

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

Detailed Description
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100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

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

Conditions
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Major Depression, Dysthymia, Depressive Disorder Not Otherwise Specified

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Imipramine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 18-65 Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified Exclusion Criteria: Known hearing impairment Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis) Hamilton Rating Scale for Depression, 17-item version > 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) Nonresponse to adequate trial of both study medications (i.e., > 4weeks on > escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., > 4 weeks on > citalopram 60 mg/d) Left-handed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluoxetine / Imipramine<br>fluoxetine or Imipramine | Drug: Fluoxetine<br>* Phase 1: 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.<br>* Other names: Prozac;Drug: Imipramine<br>* Phase 2: 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.<br>* Other names: Tofranil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) | The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating remission and scores that have decreased >= 50% from pre-treatment indicate positive response. Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1=No psychopathology 2=Minimal psychopathology 3=Mild psychopathology 4=Moderate psychopathology 5=Moderately severe psychopathology 6=Severe psychopathology 7 Extreme psychopathology. CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1=Very much improved 2=much improved 3=minimally improved 4=Unchanged 5=minimally worse 6=much worse 7=very much worse. Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define response as a CGI-I of 1 or 2; nonresponse is all other ratings (i.e., CGI-I = 3 or higher. | 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Dysthymia, Depression Not Otherwise Specified, Dichotic Listening, Fluoxetine, Imipramine, Predictors