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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.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 65 Years (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.