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