A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized,
 placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to
 compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on
 depression in patients aged 18-65. Data from the two trials will be reported in both
 individual and pooled analyses. Pooling the two studies will allow for increased power to
 detect differences between duloxetine and placebo on secondary and exploratory objectives.
 Only one data lock is planned for this study, when all patients have completed all study
 procedures.
Inclusion Criteria:

 -  Male or female outpatients

 -  Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth
 Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder
 (MDD)

 -  Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at
 visits 1 and 2

 -  Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at
 visits 1 and 2

 -  Have a degree of understanding such that the patient can provide informed consent,
 complete protocol required assessments and communicate intelligibly with the
 investigator and study coordinator.

 Exclusion Criteria:

 -  Patients judged clinically to be at serious suicidal risk in the opinion of the
 investigator

 -  Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia

 -  Patients who have any current (within the past six months) DSM-IV-TR primary Axis I
 disorder other than MDD

 -  Patients with uncontrolled narrow-angle glaucoma

 -  Patients who have a serious medical illness that is in the opinion of the investigator
 not stabilized or is likely to require intervention, hospitalization, or use of an
 excluded medication during the course of the study.