Clinical trial NCT00296777: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Dysthymia
Keywords: Major Depression
Dysthymia
f-MRI
Escitalopram
Bupropion
Imipramine
Neuropsychologic test
Dichotic listening
EEG
ERP
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 7 mos.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 7 mos.
measure: Clinical Global Impression (CGI)
timeFrame: 7 mos.
measure: Patient Global Impression (PGI)
timeFrame: 7 mos.
measure: Inventory of Depressive Symptoms (IDS)
timeFrame: 7 mos.
measure: Edinburgh Handedness Inventory
timeFrame: 7 mos.
measure: Chapman Pleasure Scale
timeFrame: 7 mos.
measure: Spielberger State/Trait Anxiety Inventory
timeFrame: 7 mos.
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service - New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
name: Jonathan W. Stewart, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.