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Dichotic Listening as a Predictor of Medication Response in Depression

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ClinicalTrials.gov Identifier: NCT00296725
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Dysthymia Depressive Disorder NOS Drug: Fluoxetine Drug: Imipramine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
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
Study Start Date : April 1994
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fluoxetine
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
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




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

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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
  • 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

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


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

Additional Information:
Publications:
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 Posted: February 27, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Imipramine
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