Dichotic Listening as a Predictor of Medication Response in Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-04-30

Study Completion Date

2011-06-30

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.

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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.

Conditions

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Major Depression Dysthymia Depressive Disorder Not Otherwise Specified

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fluoxetine / Imipramine

fluoxetine or Imipramine

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

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.

Imipramine

Intervention Type DRUG

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.

Interventions

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Fluoxetine

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.

Intervention Type DRUG

Imipramine

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.

Intervention Type DRUG

Other Intervention Names

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Prozac Tofranil

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No