A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

• Subjective Sleep Questionnaire (daily diary; 5 questions) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
• Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
• Patient Global Impression of Change (PGIC) [ Time Frame: Visits 6 and 12 ] [ Designated as safety issue: No ]
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Visits 1, 2, 6 and `12 ] [ Designated as safety issue: Yes ]
• EuroQoL 5 Dimensions (EQ 5D) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
• Patient Static Global Assessment (PSGA) [ Time Frame: Visits 2, 6, and 12 ] [ Designated as safety issue: No ]
• Columbia Suicide Severity Rating Scale (C SSRS). [ Time Frame: Visits 1-14 ] [ Designated as safety issue: Yes ]
• Work Productivity and Activity Index Specific Health Problem (WPAI SHP) [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
• Health Utilization Assessment [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

• Drug: Pregabalin
  Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
• Drug: placebo
  placebo capsules twice a day for 14 weeks

• Experimental: Pregabalin
  Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group)
  Intervention: Drug: Pregabalin
• Placebo Comparator: Placebo
  Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)
  Intervention: Drug: placebo

Inclusion Criteria:

• Men or women of any race or ethnicity who are at least 18 years of age.
• Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.

Exclusion Criteria:

• Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
• Patients with severe or unstable depression are not eligible.
• Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
• Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment