Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

NCT ID: NCT00115804

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2011-02-28

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 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.

Conditions

Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoxetine

All eligible patients were started on Fluoxetine 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.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

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

Interventions

Fluoxetine

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 Type: DRUG

Other Intervention Names

Prozac

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Lesley M. Arnold, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lesley M Arnold, M.D.

Role: PRINCIPAL_INVESTIGATOR

Women's Health Research Program

Locations

Women's Health Research Program

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

05-3-22-1

Identifier Type: -

Identifier Source: org_study_id