NCT01458964

Quetiapine Compared With Placebo in the Management of Fibromyalgia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: East Tennessee State University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Quetiapine	100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-10-25
• Last updated: 2014-07-09

Locations

1 site across 1 country: United States