Dichotic Listening as a Predictor of Medication Response in Depression - Full Text View

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 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dichotic Listening as a Predictor of Placebo and Medication Response in Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Imipramine Imipramine hydrochloride Imipramine pamoate Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

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 ]

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 ]

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 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

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)
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

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

Additional 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:

Bruder GE, Otto MW, McGrath PJ, Stewart JW, Fava M, Rosenbaum JF, Quitkin FM. Dichotic listening before and after fluoxetine treatment for major depression: relations of laterality to therapeutic response. Neuropsychopharmacology. 1996 Aug;15(2):171-9.

Bruder GE, Stewart JW, Tenke CE, McGrath PJ, Leite P, Bhattacharya N, Quitkin FM. Electroencephalographic and perceptual asymmetry differences between responders and nonresponders to an SSRI antidepressant. Biol Psychiatry. 2001 Mar 1;49(5):416-25.

Bruder GE, Stewart JW, McGrath PJ, Deliyannides D, Quitkin FM. Dichotic listening tests of functional brain asymmetry predict response to fluoxetine in depressed women and men. Neuropsychopharmacology. 2004 Sep;29(9):1752-61.

Stewart JW, Quitkin FM, McGrath PJ, Bruder GE. Do tricyclic responders have different brain laterality? J Abnorm Psychol. 1999 Nov;108(4):707-10.

Bruder GE, Stewart JW, Voglmaier MM, Harrison WM, McGrath P, Tricamo E, Quitkin FM. Cerebral laterality and depression: relations of perceptual asymmetry to outcome of treatment with tricyclic antidepressants. Neuropsychopharmacology. 1990 Feb;3(1):1-10.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bruder GE, Sedoruk JP, Stewart JW, McGrath PJ, Quitkin FM, Tenke CE. Electroencephalographic alpha measures predict therapeutic response to a selective serotonin reuptake inhibitor antidepressant: pre- and post-treatment findings. Biol Psychiatry. 2008 Jun 15;63(12):1171-7. Epub 2007 Dec 3.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00296725 History of Changes
Other Study ID Numbers:	#4217R/#5294R, continuation of IRB3112;, became IRB5294R.
Study First Received:	February 24, 2006
Last Updated:	April 26, 2012
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

Additional relevant MeSH terms:

Depression
Depressive Disorder
Dysthymic Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Imipramine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

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

ClinicalTrials.gov processed this record on June 18, 2013