Duloxetine Versus Paroxetine for Major Depression

Study Overview
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Brief Summary
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To determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.

Official Title
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Duloxetine Versus Paroxetine in the Acute Treatment of Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are male or female at least 18 years of age with nonpsychotic major depression. Females of child-bearing potential must test negative on a pregnancy test at visit 1. Exclusion Criteria: You have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality. You have a history of hepatic dysfunction, current jaundice, or positive hepatitis B surface Antigen or positive hepatitis C surface Antibody regardless of ALT. You have an ALT greater than or equal to 2 times the upper limit of normal. You have abnormal thyroid-stimulating hormone concentrations.

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: Paroxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess hypothesis that efficacy of duloxetine 60mg QD is non-inferior to paroxetine 20mg QD in treating major depressive disorder as defined by DSM-IV. Primary efficacy evaluated by mean change of HAMD17 total scores from baseline to endpoint. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD on anxiety symptoms associated with depression as measured by mean changes in Hamilton Anxiety Rating Scale (HAMA) total scores |  |  | 
| To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by mean endpoint scale on the Clinical Global Impression of Severity Scale (CGI-S) scale and the endpoint score |  |  | 
| To compare efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on symptoms of depression measured by the endpoint score on the Patient Global Impression of Improvement (PGI-I) scale |  |  | 
| To compare the efficacy of treatment with duloxetine 60 mg QD and paroxetine 20 mg QD on somatic complaints of pain as measured by the Somatic Symptom Inventory Scale (SSI) and Visual Analog Scales for pain (VAS) |  |  | 
| To compare the efficacy of duloxetine 60 mg QD and paroxetine 20 mg QD as measured by response and remission rates |  |  | 
| To compare the safety of duloxetine 60 mg QD and paroxetine 20 mg QD using information on treatment-emergent adverse events and other safety measures - e.g. electrocardiograms (ECGs) and laboratory tests |  |  |