Conditions: Fibromyalgia
Keywords: Pregabalin Lyrica depression
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 197
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Group 1 as Pregabalin vs. Placebo (cross over study in which period one has this group) arm 2: Group 2 as placebo vs. pregabalin (cross over study in which period two will have this group)

Interventions: intervention 1: Pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose intervention 2: placebo capsules twice a day for 14 weeks

Protocol document: