Dichotic Listening as a Predictor of Medication Response in Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Dysthymia; Depressive Disorder NOS
Intervention: Fluoxetine (Drug); Imipramine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s): Jonathan W. Stewart, MD., Principal Investigator, Affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
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.
Clinical Details
Official title: Dichotic Listening as a Predictor of Placebo and Medication Response in Depression
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hamilton Depression Scale (HAM-D)
Secondary outcome: Clinical Global Impression Scale (CGI)Atypical Depression Diagnostic Scale (ADDS) Deragotis Sexual Performance Scale Snaith-Hamilton Pleasure Scale Spielberger State/Trait Anxiety Scale
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Depression Evaluation Service, New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Depression Evaluation Service - official website New York State Psychiatric Institute - official website
Related 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.
Starting date: April 1994
Last updated: April 26, 2012
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