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Treatment of Depression Following Multiple Brain Tests

Primary Purpose

Major Depression, 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 Depression focused on measuring Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening, EEG, ERP

Eligibility Criteria

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

Inclusion Criteria: DSM-IV Major Depression or Dysthymia Age 18-65 Physically healthy Normal hearing Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine) Exclusion Criteria: Hearing deficit in one or both ears Body metal (e.g., wire stitches, screws in bones, stainless steel hips) History of Psychosis or Epilepsy Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Unstable medical problem Insufficient English for neuropsychological and dichotic testing Bipolar I Need for wash-out from effective treatment in order to participate Pregnant High suicide risk Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

Sites / Locations

  • Depression Evaluation Service - 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, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d

bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d

imipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, all dose increases if tolerated and not remitted

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)

Secondary Outcome Measures

Beck Depression Inventory (BDI)
Clinical Global Impression (CGI)
Patient Global Impression (PGI)
Inventory of Depressive Symptoms (IDS)
Edinburgh Handedness Inventory
Chapman Pleasure Scale
Spielberger State/Trait Anxiety Inventory

Full Information

First Posted
February 23, 2006
Last Updated
April 26, 2012
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00296777
Brief Title
Treatment of Depression Following Multiple Brain Tests
Official Title
Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
December 2007 (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
The main purpose of this study is to correlate brain testing with treatment outcome.
Detailed Description
40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymia
Keywords
Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening, EEG, ERP

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d
Arm Title
bupropion
Arm Type
Experimental
Arm Description
bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d
Arm Title
imipramine
Arm Type
Experimental
Arm Description
imipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, all dose increases if tolerated and not remitted
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
8 weeks: up to 40 mg/day
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin
Intervention Description
8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
Intervention Type
Drug
Intervention Name(s)
Imipramine
Other Intervention Name(s)
Tofranil, Pressamine
Intervention Description
8 weeks: up to 300mg/day *if patient does not have contraindication.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Time Frame
7 mos.
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
7 mos.
Title
Clinical Global Impression (CGI)
Time Frame
7 mos.
Title
Patient Global Impression (PGI)
Time Frame
7 mos.
Title
Inventory of Depressive Symptoms (IDS)
Time Frame
7 mos.
Title
Edinburgh Handedness Inventory
Time Frame
7 mos.
Title
Chapman Pleasure Scale
Time Frame
7 mos.
Title
Spielberger State/Trait Anxiety Inventory
Time Frame
7 mos.

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: DSM-IV Major Depression or Dysthymia Age 18-65 Physically healthy Normal hearing Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine) Exclusion Criteria: Hearing deficit in one or both ears Body metal (e.g., wire stitches, screws in bones, stainless steel hips) History of Psychosis or Epilepsy Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Unstable medical problem Insufficient English for neuropsychological and dichotic testing Bipolar I Need for wash-out from effective treatment in order to participate Pregnant High suicide risk Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
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
16390892
Citation
Taylor BP, Bruder GE, Stewart JW, McGrath PJ, Halperin J, Ehrlichman H, Quitkin FM. Psychomotor slowing as a predictor of fluoxetine nonresponse in depressed outpatients. Am J Psychiatry. 2006 Jan;163(1):73-8. doi: 10.1176/appi.ajp.163.1.73.
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
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
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
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
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

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Treatment of Depression Following Multiple Brain Tests

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