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The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.
An Outpatient, Randomised, Double-blind, Placebo Controlled, Parallel Group Exploratory Study to Evaluate Safety, Tolerability and Efficacy of GW679769 in Patients With Fibromyalgia Syndrome Comorbid With Depression.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of fibromyalgia (ACR criteria).
Non-severe depression (HAM-D score >14 <24).
Women must commit to consistent use of an acceptable method of birth control.
Severe depression (HAM-D score > 24).
Unable to discontinue medications for pain or depression.
Laboratory and ECG value at screening outside sponsor defined ranges.