Treatment of Depression Following Multiple Brain Tests

Major Depression Clinical Trial

Official title:

Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296777
• Other study ID #: #4781
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2006
• Last updated: April 26, 2012
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: April 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Dysthymia
• Major Depression

Intervention

Drug:
• Escitalopram
8 weeks: up to 40 mg/day
• Bupropion
8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
• Imipramine
8 weeks: up to 300mg/day *if patient does not have contraindication.

Locations

Country	Name	City	State
United States	Depression Evaluation Service - New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-D)		7 mos.	No
Secondary	Beck Depression Inventory (BDI)		7 mos.	No
Secondary	Clinical Global Impression (CGI)		7 mos.	No
Secondary	Patient Global Impression (PGI)		7 mos.	No
Secondary	Inventory of Depressive Symptoms (IDS)		7 mos.	No
Secondary	Edinburgh Handedness Inventory		7 mos.	No
Secondary	Chapman Pleasure Scale		7 mos.	No
Secondary	Spielberger State/Trait Anxiety Inventory		7 mos.	No

External Links

•   Depression Evaluation Service - official website
•   New York State Psychiatric Institute - official website