Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression

Study Overview
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Brief Summary
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The purposes of this study are to determine: The safety of duloxetine and any side effects that might be associated with it. How duloxetine compares to escitalopram and placebo (an inactive ingredient)

Detailed Description
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duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,

Official Title
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Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: duloxetine
* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 of age Must meet the criteria for major depressive disorder You must be able to visit the doctor's office about once a week for 2 to 3 months. After that, you will need to visit the doctor's office once a month for about 6 months You must be able to take the study drug as prescribed (6 capsules per day taken once-daily) Exclusion Criteria: You are a woman and are pregnant or breastfeeding. You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. You have a history of alcohol or drug dependence within the past 6 months

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine|nan|
|Drug: escitalopram|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo during acute therapy |  |  | 
| To compare the efficacy of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy |  |  | 
| To compare incidence of sexual dysfunction (defined by Changes in Sexual Functioning Questionnaire (CSFQ)), during acute therapy for patients treated with duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo. |  |  | 
| To compare sexual dysfunction during up to 8 months of treatment with duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo |  |  | 
| To compare impact of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo during acute therapy & during 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug |  |  | 
| To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo for up to 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug |  |  | 
| To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo during acute and extended therapy on resource utilization (% patients using more,less or equal number of health care providers and services) |  |  | 
| To evaluate safety and tolerability of duloxetine 60 mg once-daily vs. escitalopram 10 mg once-daily and placebo during acute therapy |  |  | 
| To evaluate the safety and tolerability of duloxetine 60-120 mg once-daily vs. escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy |  |  | 
| To compare percentage of patients taking duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo requiring a dose escalation due to less than satisfactory initial response (defined by IRB supplement or investigator request) |  |  | 
| To compare efficacy of duloxetine versus escitalopram in the placebo non-responders who enter the rescue phase |  |  |