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Dichotic Listening as a Predictor of Medication Response in Depression

N

New York State Psychiatric Institute

Status and phase

Completed
Phase 2
Phase 1

Conditions

Major Depression
Dysthymia
Depressive Disorder Not Otherwise Specified

Treatments

Drug: Imipramine
Drug: Fluoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00296725
continuation of IRB3112 (;Other Grant/Funding Number)
#4217R/#5294R
became IRB5294R. (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

fluoxetine / Imipramine
Experimental group
Description:
fluoxetine or Imipramine
Treatment:
Drug: Imipramine
Drug: Fluoxetine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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