Quetiapine Compared With Placebo in the Management of Fibromyalgia

Completed · Phase 4

Conditions studied: Fibromyalgia

In brief

Is quetiapine more effective than other medications in the treatment of fibromyalgia.

Key facts

Study ID

NCT01458964

Run by

East Tennessee State University

People needed

42

Starts

2008-01-01

Expected to finish

2013-12-01

Last updated by the study team

2014-07-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• East Tennessee State University — Johnson City, Tennessee, United States

Full record on ClinicalTrials.gov

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