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Sponsored by: |
East Tennessee State University Research Foundation |
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Information provided by: | East Tennessee State University Research Foundation |
ClinicalTrials.gov Identifier: | NCT00710918 |
The purpose of this study is to assess whether quetiapine (Seroquel XR) is an effective treatment for the management of fibromyalgia.
Condition | Intervention |
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Fibromyalgia |
Drug: quetiapine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Quetiapine Compared With Placebo in the Management of Fibromyalgia |
Estimated Enrollment: | 42 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active treatment with Seroquel XR for 12 weeks
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Drug: quetiapine
long acting 200 mg once a day for 12 weeks
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2: Placebo Comparator
Placebo treatment for 12 weeks
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Drug: Placebo
Placebo once a day for 12 weeks
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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).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Patients identified as meeting criteria for the Metabolic Syndrome, defined by meeting any 3 of the following:
Contact: Jessica L Holt, MA | 423-439-7393 | holtjl@etsu.edu |
Contact: Patrick Macmillan, MD | 423-439-2225 | macmilla@etsu.edu |
United States, Tennessee | |
ETSU College of Medicine Department of Psychiatry | Recruiting |
Johnson City, Tennessee, United States, 37614 | |
Contact: Jessica L Holt, MA 423-439-7393 holtjl@etsu.edu | |
Contact: Patrick Macmillan, MD 423-439-2225 macmilla@etsu.edu | |
Principal Investigator: Norman C Moore, MD |
Principal Investigator: | Norman C Moore, MD | East Tennessee State University |
Responsible Party: | East Tennessee State University Research Foundation ( Dr. Norman C. Moore ) |
Study ID Numbers: | ETSURFfibro2008 |
Study First Received: | July 7, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00710918 History of Changes |
Health Authority: | United States: Institutional Review Board |
Quetiapine Tranquilizing Agents Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Psychotropic Drugs Central Nervous System Depressants Pain Rheumatic Diseases Antipsychotic Agents |
Tranquilizing Agents Fibromyalgia Myofascial Pain Syndromes Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Rheumatic Diseases |
Antipsychotic Agents Pharmacologic Actions Quetiapine Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Central Nervous System Agents |