Are Two Antidepressants a Good Initial Treatment for Depression?

Study Overview
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Brief Summary
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Relatively drug naive patients will receive two antidepressant medications as initial treatment.

Detailed Description
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While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.

Official Title
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Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.

Conditions
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Major Depression, Dysthymia, Depression NOS

Intervention / Treatment
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* Drug: escitalopram + bupropion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS) HAMD-D (21-Item) > 9 Exclusion Criteria: Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d) History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia) History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable Alcohol and/or drug abuse/dependence during past year Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes) Bipolar I, Bipolar II History of Psychosis, or current Psychosis Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed) Not currently depressed (whether considered due to current treatment or not) Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis) Pregnant or breast-feeding Premenopausal women not using known effective birth control

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: escitalopram + bupropion<br>patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d | Drug: escitalopram + bupropion<br>* same dosing as for monotherapy arms<br>* Other names: bupropion = Wellbutrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) |  | 10 weeks | 
| Clinical Global Impression Scale (CGI) |  | 10 weeks | 
| Patient Global Impression Scale (PGI) |  | 10 weeks | 
| Arizona Sexual Experience Scale (ASEX) |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy