Treatment of Depression Following Multiple Brain Tests

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00296777

Enrollment

Registered

2006-02-27

Start date

2004-12-31

Completion date

2007-12-31

Last updated

2012-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysthymia, Major Depression

Keywords

Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening, EEG, ERP

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.

Interventions

DRUGEscitalopram

8 weeks: up to 40 mg/day

DRUGBupropion

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

DRUGImipramine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Scale (HAM-D)	7 mos.

Secondary

Measure	Time frame
Clinical Global Impression (CGI)	7 mos.
Patient Global Impression (PGI)	7 mos.
Inventory of Depressive Symptoms (IDS)	7 mos.
Beck Depression Inventory (BDI)	7 mos.
Chapman Pleasure Scale	7 mos.
Spielberger State/Trait Anxiety Inventory	7 mos.
Edinburgh Handedness Inventory	7 mos.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026