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).
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 tenderness at 11 or more of 18 specific tender point sites on the body. The
prevalence of JPFS in children and adolescents in the general population of the United
States is unknown. Studies from Israel, Mexico, and Italy have estimated that the prevalence
rate of JPFS in school children ranges from 1.24% to 6.20%, with girls making up the
majority of cases. Information from a national registry in the United States indicates that
JPFS accounts for about 7.7% of new patient diagnoses in a pediatric rheumatology setting.
The mean age of onset of pediatric JPFS is 12 years. As in adults, JPFS has been diagnosed
in children and adolescents using the ACR criteria. JPFS often leads to substantial
morbidity and disability. For example, adolescents with JPFS reported significantly greater
functional disability and greater number of school absences than those with other rheumatic
diseases such as juvenile RA or lupus. The presence of high levels of pain and disability at
this critical developmental stage place adolescents with JPFS at greater risk for long term
social and occupational difficulties. Early diagnosis and effective intervention are
therefore of critical importance.
- Female or male outpatients 13 to 18 years of age.
- Fulfillment of the American College of Rheumatology (ACR) criteria for primary
- 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.
- 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
- 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
- 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,
- 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, 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
- Previous treatment with fluoxetine.
- Treatment with any investigational medications within 30 days prior to screening.