Quetiapine Compared With Placebo in the Management of Fibromyalgia
Tracking Information | |||||
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First Received Date ICMJE | October 6, 2011 | ||||
Last Updated Date | August 14, 2012 | ||||
Start Date ICMJE | January 2008 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Fibromyalgia Impact Questionnaire [ Time Frame: At 25 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01458964 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Quetiapine Compared With Placebo in the Management of Fibromyalgia | ||||
Official Title ICMJE | Quetiapine Compared With Placebo in the Management of Fibromyalgia | ||||
Brief Summary | Is quetiapine more effective than other medications in the treatment of fibromyalgia. |
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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 the other treatment for an additional 12 weeks. Between treatments, subjects are required to undergo a 1-week washout where no drug is given in order to clear the effects of the first treatment. At each visit subjects will complete the following assessment: Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Beck Depression Inventory, State-Trait Anxiety Inventory, and Short Form Health Survey. Temperature, blood pressure, pulse rate, weight and waist circumference will also be recorded. Physical exams and blood tests will be performed at 1, 12, and 25 weeks |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Fibromyalgia | ||||
Intervention ICMJE | Drug: Quetiapine
100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
Other Name: Seroquel |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 42 | ||||
Estimated Completion Date | December 2013 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria :
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01458964 | ||||
Other Study ID Numbers ICMJE | 07-032f | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Dr. Norman Moore, East Tennessee State University | ||||
Study Sponsor ICMJE | East Tennessee State University | ||||
Collaborators ICMJE | AstraZeneca | ||||
Investigators ICMJE |
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Information Provided By | East Tennessee State University | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |