Dichotic Listening as a Predictor of Medication Response in Depression

Major Depressive Disorder Clinical Trial

Official title:

Dichotic Listening as a Predictor of Medication Response in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404755
• Other study ID #: #5294R
• Secondary ID: IRB 5294R
• Status: Completed
• Phase: Phase 4
• Start date: July 2006
• Est. completion date: August 2011

Study information

• Verified date: March 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Dysthymia
• Major Depressive Disorder

Intervention

Drug:
• escitalopram
Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
• bupropion
bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
• imipramine
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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks or last visit in Phase
Secondary	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).	6 weeks or last visit in Phase

External Links

•   Depression Evaluation Service official website