Dichotic Listening as a Predictor of Medication Response in Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Dysthymia
• Intervention / Treatment: Drug: escitalopram; Drug: bupropion; Drug: imipramine

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: escitalopram; 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; Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d; Other Names: Lexapro.
Experimental: bupropion; 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; bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d; Other Names: Wellbutrin
Experimental: imipramine; 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; 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; Other Names: Tofranil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Gerard Bruder, PhD, New York State Psychiatric Institute

Publications and helpful links

Helpful Links

• Depression Evaluation Service official website

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 28, 2006
• First Submitted That Met QC Criteria: November 28, 2006
• First Posted (Estimate): November 29, 2006

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Adrenergic Uptake Inhibitors; Citalopram; Bupropion; Imipramine
• Other Study ID Numbers: #5294R; IRB 5294R (Other Grant/Funding Number: There is no grantor or funder)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO