Treatment of Depression Following Multiple Brain Tests

NCT ID: NCT00296777

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-12-31

Brief Summary

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The main purpose of this study is to correlate brain testing with treatment outcome.

Detailed Description

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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.

Conditions

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Major Depression Dysthymia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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escitalopram

escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

8 weeks: up to 40 mg/day

bupropion

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

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.

imipramine

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

Group Type EXPERIMENTAL

Imipramine

Intervention Type DRUG

8 weeks: up to 300mg/day

\*if patient does not have contraindication.

Interventions

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Escitalopram

8 weeks: up to 40 mg/day

Intervention Type DRUG

Bupropion

8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.

Intervention Type DRUG

Imipramine

8 weeks: up to 300mg/day

\*if patient does not have contraindication.

Intervention Type DRUG

Other Intervention Names

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Lexapro Wellbutrin Tofranil, Pressamine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan W. Stewart, MD.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute - Columbia University Department of Psychiatry

Locations

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Depression Evaluation Service - New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16390892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2306330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8840353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10609436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11274653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15238992 (View on PubMed)

Related Links

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http://www.depression-nyc.org

Depression Evaluation Service - official website

http://www.nyspi.org

New York State Psychiatric Institute - official website

Other Identifiers

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#4781

Identifier Type: -

Identifier Source: org_study_id

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