Dichotic Listening as a Predictor of Medication Response in Depression

New York State Psychiatric Institute17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder Dysthymia

Interventions

escitalopramDRUG

Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d

bupropionDRUG

bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d

imipramineDRUG

imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 -

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

Hamilton Depression Scale (HAM-D)

Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63.

Time frame: 6 weeks or last visit in Phase

Secondary Outcomes

Clinical Global Impression Scale (CGI)

The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse).

Time frame: 6 weeks or last visit in Phase

Data from ClinicalTrials.gov

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