Dichotic Listening as a Predictor of Medication Response in Depression

NCT00404755 | Completed Phase 4 Results

• 2 other identifiers: #5294RIRB 5294R
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Dysthymia

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Global Impression Scale (CGI)

  6 weeks or last visit in Phase

Study Arms (3)

escitalopram

EXPERIMENTAL

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

Drug: escitalopram

bupropion

EXPERIMENTAL

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

Drug: bupropion

imipramine

EXPERIMENTAL

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

Drug: imipramine

Interventions

escitalopram DRUG

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

Also known as: Lexapro.

escitalopram

bupropion DRUG

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

Also known as: Wellbutrin

bupropion

imipramine DRUG

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

Also known as: Tofranil

imipramine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• Depression Evaluation Service official website

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Depression

Interventions

Escitalopram; Bupropion; Imipramine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propiophenones; Ketones; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

This is an open (i.e., unblinded) study having small sample size

Results Point of Contact

• Title: Jonathan W. Stewart, M.D.
• Organization: New York State Psychiatric Institute

jws6@columbia.edu

646-774-8000

Study Officials

• Jonathan W. Stewart, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Gerard Bruder, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 30, 2018
• Results First Posted: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)