Clinical trial NCT00296725: Dichotic Listening as a Predictor of Medication Response in Depression
Official title: Dichotic Listening as a Predictor of Placebo and Medication Response in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depression
Dysthymia
Depressive Disorder Not Otherwise Specified
Keywords: Major Depression
Dysthymia
Depression Not Otherwise Specified
Dichotic Listening
Fluoxetine
Imipramine
Predictors
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: 100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-65
* Meets Diagnostic and Statistical Manual, 4th Edition criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified

Exclusion Criteria:

* Known hearing impairment
* Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis)
* Hamilton Rating Scale for Depression, 17-item version \> 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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)
timeFrame: 6 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service, New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
name: Jonathan W. Stewart, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/0893-133X(95)00180-L.
citation: 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. doi: 10.1016/s0006-3223(00)01016-7.
citation: 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. doi: 10.1038/sj.npp.1300519.
citation: Stewart JW, Quitkin FM, McGrath PJ, Bruder GE. Do tricyclic responders have different brain laterality? J Abnorm Psychol. 1999 Nov;108(4):707-10. doi: 10.1037//0021-843x.108.4.707.
citation: 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.
citation: 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. doi: 10.1016/j.biopsych.2007.10.009. Epub 2007 Dec 3.