Treatment of Depression Following Multiple Brain Tests

Study Overview
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Brief Summary
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The main purpose of this study is to correlate brain testing with treatment outcome.

Detailed Description
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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.

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

Conditions
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Major Depression, Dysthymia

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Bupropion
* Drug: Imipramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: escitalopram<br>escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d | Drug: Escitalopram<br>* 8 weeks: up to 40 mg/day<br>* Other names: Lexapro;|
| Experimental: bupropion<br>bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d | Drug: Bupropion<br>* 8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.<br>* Other names: Wellbutrin;|
| Experimental: imipramine<br>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<br>* 8 weeks: up to 300mg/day *if patient does not have contraindication.<br>* Other names: Tofranil, Pressamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) |  | 7 mos. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERP, Major Depression, Dysthymia, f-MRI, Escitalopram, Bupropion, Imipramine, Neuropsychologic test, Dichotic listening, EEG