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CompletedNCT00296777Updated Apr 27, 2012

Treatment of Depression Following Multiple Brain Tests

A Phase 4 interventional study of Escitalopram and Bupropion in Major Depression and Dysthymia, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Major Depression
  • Dysthymia

Keywords

  • Major Depression
  • Dysthymia
  • f-MRI
  • Escitalopram
  • Bupropion
  • Imipramine
  • Neuropsychologic test
  • Dichotic listening
  • EEG
  • ERP
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 28 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    escitalopram

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

    Drug: Escitalopram

  • Experimental
    bupropion

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

    Drug: Bupropion

  • Experimental
    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

    Drug: Imipramine

Interventions

  • DrugEscitalopram

    8 weeks: up to 40 mg/day

    Also known as: Lexapro

  • DrugBupropion

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

    Also known as: Wellbutrin

  • DrugImipramine

    8 weeks: up to 300mg/day \*if patient does not have contraindication.

    Also known as: Tofranil, Pressamine

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What researchers measure

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 7 mos.

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: 7 mos.

  2. Clinical Global Impression (CGI)

    Time frame: 7 mos.

  3. Patient Global Impression (PGI)

    Time frame: 7 mos.

  4. Inventory of Depressive Symptoms (IDS)

    Time frame: 7 mos.

  5. Edinburgh Handedness Inventory

    Time frame: 7 mos.

  6. Chapman Pleasure Scale

    Time frame: 7 mos.

  7. Spielberger State/Trait Anxiety Inventory

    Time frame: 7 mos.

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Study locations

1 site
  • Depression Evaluation Service - New York State Psychiatric Institute
    New York, New York 10032, United States
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References and documents

Publications

  • 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. PubMed 16390892 ↗
  • 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. PubMed 2306330 ↗
  • 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. PubMed 8840353 ↗
  • 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. PubMed 10609436 ↗
  • 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. PubMed 11274653 ↗
  • 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. PubMed 15238992 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00296777
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sponsor
First posted
Feb 27, 2006
Start date
Dec 2004
Primary completion
May 2007
Completion
Dec 2007
Last update
Apr 27, 2012

Study contacts

Jonathan W. Stewart, MD.
principal investigator · New York State Psychiatric Institute - Columbia University Department of Psychiatry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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