A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
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.