Treatment of Depression Following Multiple Brain Tests
Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
1 other identifier
interventional
28
1 country
1
Brief Summary
The main purpose of this study is to correlate brain testing with treatment outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedApril 27, 2012
April 1, 2012
2.4 years
February 23, 2006
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Scale (HAM-D)
7 mos.
Secondary Outcomes (7)
Beck Depression Inventory (BDI)
7 mos.
Clinical Global Impression (CGI)
7 mos.
Patient Global Impression (PGI)
7 mos.
Inventory of Depressive Symptoms (IDS)
7 mos.
Edinburgh Handedness Inventory
7 mos.
- +2 more secondary outcomes
Study Arms (3)
escitalopram
EXPERIMENTALescitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d
bupropion
EXPERIMENTALbupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d
imipramine
EXPERIMENTALimipramine 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
Interventions
8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
8 weeks: up to 300mg/day \*if patient does not have contraindication.
Eligibility Criteria
You may qualify if:
- DSM-IV Major Depression or Dysthymia
- Age 18-65
- Physically healthy
- Normal hearing
- Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (6)
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.
PMID: 16390892BACKGROUNDBruder 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.
PMID: 2306330BACKGROUNDBruder 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.
PMID: 8840353BACKGROUNDStewart 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.
PMID: 10609436BACKGROUNDBruder 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.
PMID: 11274653BACKGROUNDBruder 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.
PMID: 15238992BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan W. Stewart, MD.
New York State Psychiatric Institute - Columbia University Department of Psychiatry
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
December 1, 2004
Primary Completion
May 1, 2007
Study Completion
December 1, 2007
Last Updated
April 27, 2012
Record last verified: 2012-04