Quetiapine Compared With Placebo in the Management of Fibromyalgia
The purpose of this study is to assess whether quetiapine (Seroquel XR) is an effective treatment for the management of fibromyalgia.
Fibromyalgia causes widespread muscle pain, tender points on the body, and fatigue. It affects 3-6% of Americans, mostly middle-aged women, and as many as 30% of patients are unable to maintain full-time employment. Conventional analgesics rarely reduce the pain, and even strong narcotics rarely eliminate it. This is a double-blind placebo-controlled 24-week crossover study of 42 patients. For the first 12 weeks, 21 will be on Seroquel XR 200 mg and 21 will be on placebo. After one week of washout, they will switch to the other compound for the next 12 weeks. Participants will be18 years or older, meet the American College of Rheumatology criteria for fibromyalgia and will have not satisfactorily responded to their previous treatment. The primary outcome measure will be the mean change from baseline to endpoint in the FIQ total score. Secondary efficacy measures will be the CGI (Clinical Global Impression), PSQI (Pittsburgh Sleep Quality Index), BDI (Beck Depression Inventory), STAI (State-Trait Anxiety Inventory) and SF-12 (Short-Form 12 Health Inventory), as well as individual items of the FIQ (Fibromyalgia Impact Questionnaire).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ETSU College of Medicine Department of Psychiatry
East Tennessee State University Research Foundation
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00710918
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Fatigue Syndrome, Chronic
A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9)
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