Quetiapine Compared With Placebo in the Management of Fibromyalgia

  • participants needed
  • sponsor
    East Tennessee State University Research Foundation
Updated on 7 November 2020


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 25-week crossover study of 42 patients. The first appointment will assess patients' eligibility to participate. For the first 12 weeks after screening, 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 be 18 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).

Condition Fibromyalgia
Treatment Placebo, Quetiapine
Clinical Study IdentifierNCT00710918
SponsorEast Tennessee State University Research Foundation
Last Modified on7 November 2020


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