Is quetiapine more effective than other medications in the treatment of fibromyalgia.
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Full eligibility criteria for NCT01458964
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age 18 to 60, inclusive
Females of childbearing potential using reliable method of contraception AND negative urine pregnancy test.
Widespread pain present for at least 3 months
Widespread encompassing both sides of the body, as well as above and below the waist
Pain in at least 11 of 18 tender points as determined by a physician
Pregnant or breastfeeding
Use of any of the following in the 14 days prior to enrollment: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, saquinavir phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrollment
Substance or alcohol dependence at enrollment (except in full or recovery, and except nicotine or caffeine dependence)
Abuse of any of the following within 4 weeks of enrollment: opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen
Medical conditions that would affect study treatment
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by investigator
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study
Participation in another drug trial within 4 weeks prior to enrollment in this study or longer
Admitted to hospital for Diabetes Mellitus (DM) related illness in past 12 weeks
Not under physician's care for DM
Physician responsible for your DM care has indicated you DM is uncontrolled
Physician responsible for your DM care has not approved your participation in the study
Have not been on the same dose of DM medicine and/or diet for the 4 weeks prior to starting the study
For thiazolidinediones (glitazones) this period should not be less than 8 weeks
Taking insulin whose daily does on one occasion in the past 4 weeks has been more than 10% above or below your mean dose in the preceding 4 weeks
A low white blood cell count
All locations for NCT01458964
United States (1)
East Tennessee State University
Johnson City, Tennessee, United States, 37614
View full eligibility
Tris trial is registered with FDA with number: NCT01458964. The sponsor of the trial is East Tennessee State University and it is looking for 42 volunteers for the current phase.
Official trial title: Quetiapine Compared With Placebo in the Management of Fibromyalgia
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