Status:
COMPLETED
Quetiapine Compared With Placebo in the Management of Fibromyalgia
Lead Sponsor:
East Tennessee State University
Collaborating Sponsors:
AstraZeneca
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Is quetiapine more effective than other medications in the treatment of fibromyalgia.
Detailed Description
This study is a double blind, placebo controlled, 24-week crossover design. For 12 weeks subjects receive either study medication (200mg Quetiapine) or placebo, after which they will be switched to th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01458964
Start Date
January 1 2008
End Date
December 1 2013
Last Update
July 9 2014
Active Locations (1)
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1
East Tennessee State University
Johnson City, Tennessee, United States, 37614