Clinical Trial Testing the Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

Condition(s) targeted: Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia

Intervention: Fluoxetine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Lesley M Arnold, M.D., Principal Investigator, Affiliation: Women's Health Research Program

Overall contact:
Megan Clayton, Phone: 513-475-8113, Email: claytoma@ucmail.uc.edu

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).

Official title: An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Severity of pain from the 100-mm visual analog scale of the Pediatric Pain Questionnaire

Secondary outcome:

The Mean Tender Point Pain Threshold will be assessed for all 18 tender points.

The Clinical Global Impression of Severity scale evaluates the severity of illness at the time of assessment.

The Patient Global Impression of Improvement measures the degree of improvement since randomization at the time of the assessment.

The Functional Disability Inventory-child version assesses perceived difficulty in performing activities in the domains of school, home, recreation, and social interactions.

The Functional Disability Inventory-parent version consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing activities in physical and psychosocial domains.

Children's Depression Inventory is a self-reported scale that is widely used in studies of children with fibromyalgia.

Multidimensional Anxiety Scale for Children is a self-report inventory that assesses four areas of anxiety symptoms.

Fibromyalgia Impact Questionnaire Modified for Children is a self-report instrument that measures function, pain, fatigue, sleep quality, stiffness, anxiety and depression.

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.

Minimum age: 13 Years. Maximum age: 18 Years. Gender(s): Both.

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, 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.

Megan Clayton, Phone: 513-475-8113, Email: claytoma@ucmail.uc.edu

Women's Health Research Program, Cincinnati, Ohio 45219, United States; Recruiting
Megan Clayton, Phone: 513-475-8113, Email: claytoma@ucmail.uc.edu
Lesley M Arnold, M.D., Principal Investigator

Starting date: June 2005
Ending date: June 2009
Last updated: October 9, 2009