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Dichotic Listening as a Predictor of Medication Response in Depression

Primary Purpose

Major Depressive Disorder, Dysthymia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
escitalopram
bupropion
imipramine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

escitalopram

bupropion

imipramine

Arm Description

escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d

bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
November 28, 2006
Last Updated
March 29, 2018
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00404755
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymia
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d
Arm Title
bupropion
Arm Type
Experimental
Arm Description
bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted
Arm Title
imipramine
Arm Type
Experimental
Arm Description
imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro.
Intervention Description
Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d
Intervention Type
Drug
Intervention Name(s)
bupropion
Other Intervention Name(s)
Wellbutrin
Intervention Description
bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d
Intervention Type
Drug
Intervention Name(s)
imipramine
Other Intervention Name(s)
Tofranil
Intervention Description
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
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Description
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 Outcome Measure Information:
Title
Clinical Global Impression Scale (CGI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages between 18-65 Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) 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 (HAMD), 21-item total score >20 Current (past 6 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 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) Premenopausal women not using known effective birth control Not currently depressed (whether considered due to current treatment or not) History of seizure, seizure disorder, anorexia nervosa, or bulimia Left-handed -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W. Stewart, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerard Bruder, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.depression-nyc.org
Description
Depression Evaluation Service official website

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Dichotic Listening as a Predictor of Medication Response in Depression

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