Objective. Fibromyalgia and major depressive disorder (MDD) frequently co-occur. Quetiapine fumarate extended-release (quetiapine XR) has demonstrated efficacy in the treatment of MDD and has been shown to have analgesic properties in patients with depression. The primary objectives of this study were to evaluate the effects of quetiapine XR on depressive and pain symptoms in patients with MDD and comorbid fibromyalgia, and to assess its safety and tolerability. Results. The mean change in the HAM-D score from baseline to week 8 was significantly greater in the quetiapine XR group compared with the placebo group (؊10.0 versus ؊5.8; P ‫؍‬ 0.001). Improvements in most secondary outcomes were also significantly greater in the quetiapine XR group. Quetiapine XR was generally well tolerated.Conclusion. This study is the first to demonstrate that measures of depression, pain, and quality of life are significantly improved with quetiapine XR compared with placebo in patients with a dual diagnosis of MDD and fibromyalgia.Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain that lasts at least 3 months, with a reduced pain threshold. Widespread pain is the defining feature of fibromyalgia. Associated symptoms include fatigue, sleep disturbance, stiffness, cognitive symptoms, and mood abnormalities including depression and anxiety (1,2). Pain, fatigue, and sleep disturbance are present in at least 75% of patients (3). The condition is estimated to occur in ϳ2-4% of the general adult population (4,5), and the prevalence is higher among women (4.9%) than men (1.6%) (6).Patients with fibromyalgia are at increased risk of mood disorders. Studies suggest that the prevalence of current depression among patients with fibromyalgia is as high as 22-40% (7), and that lifetime prevalence rates reach 58-86% (8,9). This high degree of co-occurrence is thought to be related in part to pathophysiologic abnormalities that are shared between fibroClinicalTrials.gov identifier: NCT00675896.

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Introduction:Fibromyalgia and major depressive disorder (MDD) frequently co-occur. Quetiapine XR has demonstrated efficacy in the treatment of MDD and has recently been shown effective in patients with fibromyalgia.Objectives:To evaluate the efficacy and safety of quetiapine XR in patients with MDD and comorbid fibromyalgia.Aims:To report on the antidepressant and analgesic effects of quetiapine XR in a sample of dually diagnosed patients.Methods:An 8-week double-blind, randomized controlled trial in 120 non-psychotic adult outpatients with a confirmed diagnosis of MDD and fibromyalgia. Quetiapine XR was administered once daily in the evening at a starting dose of 50 mg/d for 2 days then 150 mg/d for 2 weeks and up to 300 mg/d if needed. The primary efficacy endpoint was mean change from baseline to week 8 on the HAM-D17 total score. Secondary endpoints included other measures of depression, anxiety, pain, quality of life, global functioning and adverse events.Results:At week 8, mean change in HAM-D17 score from baseline was significantly greater in the quetiapine XR arm than placebo (-10.0 vs. -5.8, p=0.001). Improvements in the Fibromyalgia Impact Questionaire (FIQ total -11.1 vs. -3.9, p=0.022) and Brief Pain Inventory (BPI-Total -2.1 vs. -1.6, p=0.007) was significantly greater in the quetiapine XR arm versus placebo. Improvements in all secondary outcomes were significantly greater in the quetiapine XR with the exception of the Sheehan Disability Scale total score.Conclusions:Quetiapine XR demonstrated significant antidepressive and analgesic effects in this population of patients with MDD and fibromyalgia.