Duloxetine Versus Placebo for Fibromyalgia

Duloxetine Versus Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.

Inclusion Criteria:

• You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

• Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
• Abnormal thyroid-stimulating hormone concentrations.