Abstract
Objective: To assess the efficacy of duloxetine on reduction of pain severity in women with primary fibromyalgia, with or without major depressive disorder (MDD). Design: Two 12-week randomized, double-blind, placebo-controlled trials. Setting: University and clinical trial research sites, pain clinics, rheumatologists, and psychiatric sites. Participants: Adult outpatients met American College of Rheumatology criteria for primary fibromyalgia. Interventions: Study 1: 60mg of duloxetine twice daily (DLX60BID) (N=92) versus placebo (N=92).
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