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Completed

NCT Number: NCT00404755

Dichotic Listening as a Predictor of Medication Response in Depression

This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder 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 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 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 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. 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, Fourth Edition (DSM-IV) 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 (HAMD), 21-item total score >20
  • Current (past 6 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
  • Non-response to adequate trial of study medication (i.e., > or = 4 weeks on > or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)
  • Premenopausal women not using known effective birth control
  • Not currently depressed (whether considered due to current treatment or not)
  • History of seizure, seizure disorder, anorexia nervosa, or bulimia
  • Left-handed -

Treatment and study plan

Escitalopram

Drug

Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d

Other names: Lexapro.

bupropion

Drug

bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d

Other names: Wellbutrin

Imipramine

Drug

imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted

Other names: Tofranil

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 6 weeks or last visit in Phase

    Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.

Secondary outcomes

  1. Clinical Global Impression Scale (CGI)

    Time frame: 6 weeks or last visit in Phase

    The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from

    1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse).

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2006
Registry last updated
Apr 30, 2018

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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