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Completed

NCT Number: NCT00296725

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) until remitted, to see whether test results predict specific outcomes.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder Not Otherwise Specified Depressive Disorder, Major Dysthymia Dysthymic Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Depression Evaluation Service, New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

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.

Other names: Prozac

Imipramine

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.

Other names: Tofranil

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)

    Time frame: 6 weeks.

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
2011
Study completion
2011
First posted
Feb 27, 2006
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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