At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
In Brief
A Phase 4 clinical trial evaluating Duloxetine hydrochloride and Placebo for Major Depressive Disorder. Completed, enrolled 776 participants across 47 sites in 2 countries.
Detailed 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.