Quetiapine Compared With Placebo in the Management of Fibromyalgia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Tennessee State University
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria :

• 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