Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Fluoxetine

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.