Dichotic Listening as a Predictor of Medication Response in Depression

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fluoxetine

Imipramine

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Dysthymia, Depression Not Otherwise Specified, Dichotic Listening, Fluoxetine, Imipramine, Predictors

Eligibility Criteria

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

Inclusion Criteria: Ages between 18-65 Meets Diagnostic and Statistical Manual, 4th Edition 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, 17-item version > 20 Current (past six 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 If currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for Prozac) or felt to require other psychiatric medication (other than occasional sleep or Anxiety medication) Premenopausal women not using known effective birth control Not currently depressed (whether considered due to current treatment or not) Nonresponse to adequate trial of both study medications (i.e., > 4weeks on > escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., > 4 weeks on > citalopram 60 mg/d) Left-handed

Sites / Locations

Depression Evaluation Service, New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fluoxetine / Imipramine

Arm Description

fluoxetine or Imipramine

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)

The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating "remission" and scores that have decreased >= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms.

Secondary Outcome Measures

Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)

The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1="No psychopathology" 2="Minimal psychopathology" 3="Mild psychopathology 4="Moderate psychopathology" 5="Moderately severe psychopathology" 6="Severe psychopathology" 7 "Extreme psychopathology". CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1="Very much improved" 2="much improved" 3="minimally improved" 4="Unchanged" 5="minimally worse" 6="much worse" 7="very much worse". Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define "response" as a CGI-I of 1 or 2; "nonresponse" is all other ratings (i.e., CGI-I = 3 or higher.

Full Information

NCT ID

NCT00296725

First Posted

February 24, 2006

Last Updated

May 15, 2019

Sponsor

New York State Psychiatric Institute

1. Study Identification

Unique Protocol Identification Number

NCT00296725

Brief Title

Dichotic Listening as a Predictor of Medication Response in Depression

Official Title

Dichotic Listening as a Predictor of Placebo and Medication Response in Depression

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

April 1994 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.

Detailed Description

100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. 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 Depression, Dysthymia, Depressive Disorder Not Otherwise Specified

Keywords

Major Depression, Dysthymia, Depression Not Otherwise Specified, Dichotic Listening, Fluoxetine, Imipramine, Predictors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fluoxetine / Imipramine

Arm Type

Experimental

Arm Description

fluoxetine or Imipramine

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Other Intervention Name(s)

Prozac

Intervention Description

Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.

Intervention Type

Drug

Intervention Name(s)

Imipramine

Other Intervention Name(s)

Tofranil

Intervention Description

Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated.

Primary Outcome Measure Information:

Title

Hamilton Depression Scale (HAM-D)

Description

The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of <=7 are accepted as indicating "remission" and scores that have decreased >= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I)

Description

The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1="No psychopathology" 2="Minimal psychopathology" 3="Mild psychopathology 4="Moderate psychopathology" 5="Moderately severe psychopathology" 6="Severe psychopathology" 7 "Extreme psychopathology". CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1="Very much improved" 2="much improved" 3="minimally improved" 4="Unchanged" 5="minimally worse" 6="much worse" 7="very much worse". Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define "response" as a CGI-I of 1 or 2; "nonresponse" is all other ratings (i.e., CGI-I = 3 or higher.

Time Frame

6 weeks.

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, 4th Edition 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, 17-item version > 20 Current (past six 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 If currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for Prozac) or felt to require other psychiatric medication (other than occasional sleep or Anxiety medication) Premenopausal women not using known effective birth control Not currently depressed (whether considered due to current treatment or not) Nonresponse to adequate trial of both study medications (i.e., > 4weeks on > escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., > 4 weeks on > citalopram 60 mg/d) Left-handed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan W. Stewart, MD.

Organizational Affiliation

New York State Psychiatric Institute - Columbia University Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Depression Evaluation Service, New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8840353

Citation

Bruder GE, Otto MW, McGrath PJ, Stewart JW, Fava M, Rosenbaum JF, Quitkin FM. Dichotic listening before and after fluoxetine treatment for major depression: relations of laterality to therapeutic response. Neuropsychopharmacology. 1996 Aug;15(2):171-9. doi: 10.1016/0893-133X(95)00180-L.

Results Reference

background

PubMed Identifier

11274653

Citation

Bruder GE, Stewart JW, Tenke CE, McGrath PJ, Leite P, Bhattacharya N, Quitkin FM. Electroencephalographic and perceptual asymmetry differences between responders and nonresponders to an SSRI antidepressant. Biol Psychiatry. 2001 Mar 1;49(5):416-25. doi: 10.1016/s0006-3223(00)01016-7.

Results Reference

background

PubMed Identifier

15238992

Citation

Bruder GE, Stewart JW, McGrath PJ, Deliyannides D, Quitkin FM. Dichotic listening tests of functional brain asymmetry predict response to fluoxetine in depressed women and men. Neuropsychopharmacology. 2004 Sep;29(9):1752-61. doi: 10.1038/sj.npp.1300519.

Results Reference

background

PubMed Identifier

10609436

Citation

Stewart JW, Quitkin FM, McGrath PJ, Bruder GE. Do tricyclic responders have different brain laterality? J Abnorm Psychol. 1999 Nov;108(4):707-10. doi: 10.1037//0021-843x.108.4.707.

Results Reference

background

PubMed Identifier

2306330

Citation

Bruder GE, Stewart JW, Voglmaier MM, Harrison WM, McGrath P, Tricamo E, Quitkin FM. Cerebral laterality and depression: relations of perceptual asymmetry to outcome of treatment with tricyclic antidepressants. Neuropsychopharmacology. 1990 Feb;3(1):1-10.

Results Reference

background

PubMed Identifier

18061147

Citation

Bruder GE, Sedoruk JP, Stewart JW, McGrath PJ, Quitkin FM, Tenke CE. Electroencephalographic alpha measures predict therapeutic response to a selective serotonin reuptake inhibitor antidepressant: pre- and post-treatment findings. Biol Psychiatry. 2008 Jun 15;63(12):1171-7. doi: 10.1016/j.biopsych.2007.10.009. Epub 2007 Dec 3.

Results Reference

derived

Links:

URL

http://www.depression-nyc.org

Description

Depression Evaluation Service - official website

URL

http://www.nyspi.org

Description

New York State Psychiatric Institute - official website

Major Depression, Dysthymia, Depressive Disorder Not Otherwise Specified

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial