Treatment of Depression Following Multiple Brain Tests

Phase 4

Completed

• Conditions: Major Depression; Dysthymia
• Interventions: Drug: Bupropion; Drug: Escitalopram; Drug: Imipramine

• Registration Number: NCT00296777
• Lead Sponsor: New York State Psychiatric Institute

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Primary Completion: 2007-05
• Study Completion: 2007-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bupropion	Bupropion	bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d
escitalopram	Escitalopram	escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d
imipramine	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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D)	7 mos.

Secondary Outcome Measures

Name	Time	Method
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.
Chapman Pleasure Scale	7 mos.
Spielberger State/Trait Anxiety Inventory	7 mos.

Trial Locations

Locations (1)

Depression Evaluation Service - New York State Psychiatric Institute; 🇺🇸 New York, New York, United States