- Male or female of any race, at least 18 years of age
- Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for
at least 3 months, and pain in at least 11 of 18 specific tender point sites)
- Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic
Neuralgia) that may confound assessment or self evaluation of the pain associated with
fibromyalgia
- Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other
than fibromyalgia), active infection, or untreated endocrine disorder
- A current or recent diagnosis (last 6 months) or episode of major depressive disorder,
dysthymia and/or uncontrolled depression
- History of mania, hypomania, other psychotic disorder, or current mood disorder with
psychotic features