Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

• Sheehan Disability Scale total score
• Average pain item of the BPI and the endpoint of the PGI-Improvement
• Reduction of pain severity
• Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
• Quality of life
• Effect duloxetine on pain is independent of MDD or mood improvement
• Assess safety of duloxetine

• -Sheehan Disability Scale total score
• -Average pain item of the BPI and the endpoint of the PGI-Improvement
• -Reduction of pain severity
• -Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
• -Quality of life
• -Effect duloxetine on pain is independent of MDD or mood improvement
• -Assess safety of duloxetine

To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.

• Drug: Duloxetine
• Drug: placebo

• Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6.
• Russell IJ, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-44. Epub 2008 Apr 18.

Inclusion Criteria:

• Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

Exclusion Criteria:

• Have any current primary Axis I diagnosis other than major depressive disorder
• Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
• Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
• Have regional pain syndrome, multiple surgeries or failed back syndrome
• Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)