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Dichotic Listening as a Predictor of Medication Response in Depression

This study has been completed.

Sponsored by: New York State Psychiatric Institute
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296725
  Purpose

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


Condition Intervention Phase
Major Depression
Dysthymia
Depressive Disorder NOS
Drug: Fluoxetine
Drug: Imipramine
Phase IV

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Fluoxetine    Fluoxetine hydrochloride    Imipramine    Imipramine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Official Title:   Dichotic Listening as a Predictor of Placebo and Medication Response in Depression

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Fuse Words Test [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Nonsense Syllables Test [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Complex Tones Test [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale (CGI) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Atypical Depression Diagnostic Scale (ADDS) [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Deragotis Sexual Performance Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Snaith-Hamilton Pleasure Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]
  • Spielberger State/Trait Anxiety Scale [ Time Frame: 6 mos. ] [ Designated as safety issue: No ]

Estimated Enrollment:   130
Study Start Date:   April 1994

Intervention Details:
    Drug: 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.
    Drug: 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.
Detailed Description:

Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during six 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 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Placebo, Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Ages between 18-65
  • Meets DSM-IV criteria for current Major Depression, Dysthymia or Depression NOS

Exclusion Criteria:

  • Known hearing impairment
  • Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis)
  • HAMD > 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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296725

Locations
United States, New York
Depression Evaluation Service, New York State Psychiatric Institute    
      New York, New York, United States, 10032

Sponsors and Collaborators
New York State Psychiatric Institute

Investigators
Principal Investigator:     Jonathan W. Stewart, MD.     New York State Psychiatric Institute - Columbia University Department of Psychiatry    
  More Information

Depression Evaluation Service - official website  This link exits the ClinicalTrials.gov site
 
New York State Psychiatric Institute - official website  This link exits the ClinicalTrials.gov site
 

Publications:

Publications indexed to this study:

Responsible Party:   New York State Psychiatric Institute ( Jonathon W. Stewart, M.D. )
Study ID Numbers:   IRB4217R, continuation of IRB3112;, became IRB5294R.
First Received:   February 24, 2006
Last Updated:   January 14, 2008
ClinicalTrials.gov Identifier:   NCT00296725
Health Authority:   United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Major Depression  
Dysthymia  
Depression NOS  
Dichotic Listening  
Fluoxetine
Imipramine
Placebo
Predictors

Study placed in the following topic categories:
Fluoxetine
Imipramine
Depression
Mental Disorders
Mood Disorders
Dysthymic Disorder
Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on August 21, 2008




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