At a glance
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Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
In Brief
A Phase 4 clinical trial evaluating Duloxetine and Placebo for Major Depressive Disorder. Completed, enrolled 527 participants across 34 sites in 2 countries.
Detailed Summary
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
Study Details
Timeline
Interventions
Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.