Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Study Overview
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Brief Summary
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The primary objective of this study was to compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. The study hypothesis was that there were clinically important differences between the two drugs in terms of efficacy and adverse event profiles.

Detailed Description
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Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. The lifetime prevalence of Major Depressive Disorder (MDD) in community samples is 10-25% for women and 5-12% for men. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. At its worst, depression may lead to suicide. Depression is recurrent in 75-80% of patients and becomes chronic in 15-20% of depressed patients. The selective serotonin reuptake inhibitors (SSRIs) have become the leading class of antidepressants throughout the world. The efficacy and safety of SSRIs in the treatment of depression has been demonstrated in several clinical trials. With respect to safety, the studies show an advantage for the SSRIs over the older antidepressants. If the prescribing physicians are to make a well-founded judgement in their choice of drug factors like efficacy, safety, quality of life, and health economics must be taken into consideration. The primary aim of this study is to compare the efficacy of escitalopram with that of the serotonin norepinephrine reuptake inhibitors (SNRIs) duloxetine in the treatment of MDD.

Official Title
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A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx; current episode assessed using the MINI) The patient has a MADRS total score >=26 and a CGI-S score >=4 at the Baseline Visit Exclusion Criteria: Any current psychiatric disorder other than MDD as defined in the DSM-IV TR Female patients of childbearing potential who are not using effective contraception Use of any psychoactive medication 2 weeks prior to screening and during the study Other protocol-defined inclusion and exclusion criteria may apply.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br> | Drug: Escitalopram<br>* 20mg once daily; orally<br>* Other names: Cipralex, Lexapro;|
| Active Comparator: Duloxetine<br> | Drug: Duloxetine<br>* 60mg once daily; orally<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at the end of 24 weeks |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD. | Secondary efficacy endpoints will be based on the MADRS, the Hamilton Depression Rating Scale (HAM-D17), the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-S, the CGI-I and the Sheehan Disability Scale (SDS), Remission (MADRS<=12) and response (>=50% decrease from baseline in MADRS). | Up to 24 weeks | 
| To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD. | Adverse events, clinical safety laboratory tests, vital signs | Up to 24 weeks | 
| To evaluate the discontinuation emergent signs and symptoms during and after taper-down treatment with escitalopram or duloxetine after 24 weeks of treatment assessed by the Discontinuation Emergent Signs and Symptoms Scale (DESS). |  | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive disorder, major, Randomized controlled trials, Antidepressive agents