Clinical trial NCT00404755: Dichotic Listening as a Predictor of Medication Response in Depression
Official title: Dichotic Listening as a Predictor of Medication Response in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Dysthymia
Keywords: Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.

Detailed description: Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 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 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Eligibility criteria: Inclusion Criteria:

1. Ages between 18-65
2. Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) criteria for current Major Depression, Dysthymia or Depression Not Otherwise Specified

Exclusion Criteria:

1. Known Hearing impairment
2. Active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis).
3. Hamilton Rating Scale for Depression (HAMD), 21-item total score \>20
4. Current (past 6 months)alcohol and/or drug abuse or dependence
5. Medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by Imipramine)
6. Bipolar I
7. Psychosis
8. Non-response to adequate trial of study medication (i.e., \> or = 4 weeks on \> or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)
9. Premenopausal women not using known effective birth control
10. Not currently depressed (whether considered due to current treatment or not)
11. History of seizure, seizure disorder, anorexia nervosa, or bulimia
12. Left-handed -

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 6 weeks or last visit in Phase
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: 6 weeks or last visit in Phase
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jonathan W. Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute
name: Gerard Bruder, PhD
role: PRINCIPAL_INVESTIGATOR
References: