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Dichotic Listening as a Predictor of Medication Response in Depression

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 27, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dichotic Listening as a Predictor of Placebo and Medication Response in Depression

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 6 mos. ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale (CGI) [ Time Frame: 6 mos. ]
  • Atypical Depression Diagnostic Scale (ADDS) [ Time Frame: 6 mos. ]
  • Deragotis Sexual Performance Scale [ Time Frame: 6 mos. ]
  • Snaith-Hamilton Pleasure Scale [ Time Frame: 6 mos. ]
  • Spielberger State/Trait Anxiety Scale [ Time Frame: 6 mos. ]

Enrollment: 130
Study Start Date: April 1994
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluoxetine
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.
Other Name: Prozac
Experimental: imipramine
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.
Other Name: Tofranil

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296725

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296725     History of Changes
Other Study ID Numbers: #4217R/#5294R
continuation of IRB3112; ( Other Grant/Funding Number: There is no grantor or funder )
became IRB5294R. ( Other Grant/Funding Number: there is no grantor or funder )
First Submitted: February 24, 2006
First Posted: February 27, 2006
Last Update Posted: October 12, 2017
Last Verified: April 2012

Keywords provided by New York State Psychiatric Institute:
Major Depression
Depression NOS
Dichotic Listening

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Adrenergic Agents