Status:
COMPLETED
Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
Lead Sponsor:
University of Cincinnati
Conditions:
Juvenile Primary Fibromyalgia Syndrome (JPFS)
Fibromyalgia
Eligibility:
All Genders
13-18 years
Phase:
PHASE3
Brief Summary
The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).
Detailed Description
Fibromyalgia is a common condition that is often challenging to treat. It is defined by the American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in combination with ...
Eligibility Criteria
Inclusion
- Female or male outpatients 13 to 18 years of age.
- Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
- Ability to understand and cooperate with study procedures.
- Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.
Exclusion
- Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
- Lifetime history of psychosis, hypomania or mania.
- Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
- Patients judged to be at serious suicide or homicide risk.
- Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
- Clinically unstable medical or psychiatric conditions that could interfere with the absorption, metabolism, excretion, or safety of fluoxetine or interfere with the assessment of disease severity.
- Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant fibromyalgia symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis).
- History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
- Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.
- Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.
- Treatment with any other excluded medication that cannot be discontinued at the screening visit.
- Previous treatment with fluoxetine.
- Treatment with any investigational medications within 30 days prior to screening.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00115804
Start Date
June 1 2005
End Date
February 1 2011
Last Update
February 10 2017
Active Locations (1)
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1
Women's Health Research Program
Cincinnati, Ohio, United States, 45219