Duloxetine vs. Active Comparator for the Treatment of Depression

Study Overview
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Brief Summary
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How duloxetine compares to a medication currently available for the treatment of depression in the treatment of patients with major depressive disorder. The safety of duloxetine and any side effects that might be associated with it.

Official Title
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Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

Conditions
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Depression

Intervention / Treatment
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* Drug: Duloxetine Hydrochloride
* Drug: Venlafaxine Extended Release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be at least 18 years of age must be diagnosed with depression must sign informed consent Exclusion Criteria: women who can become pregnant must be using birth control previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder history of substance abuse or dependence in the last year patients who are suicidal frequent or severe allergic reactions with multiple medications

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 Hydrochloride|nan|
|Drug: Venlafaxine Extended Release|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint. |  |  | 
| HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17. |  |  | 
| HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint. |  |  | 
| Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy. |  |  | 
| Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment. |  |  | 
| Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms. |  |  | 
| HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia. |  |  |