Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
Condition: Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Intervention: Fluoxetine
Intervention description: Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
Intervention MeSH terms: Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 6.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Juvenile

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.