Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
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).
Juvenile Primary Fibromyalgia Syndrome (JPFS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome|
- Average Pain Severity Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale.
- The Clinical Global Impression of Severity Scale Evaluates the Severity of Illness at the Time of Assessment. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
- The Patient Global Impression of Improvement Measures the Degree of Improvement Since Randomization at the Time of the Assessment. [ Time Frame: since randomization at the time of the assessment ] [ Designated as safety issue: No ]
- The Functional Disability Inventory-child Version Assesses Perceived Difficulty in Performing Activities in the Domains of School, Home, Recreation, and Social Interactions. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
- 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. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
- Children's Depression Inventory is a Self-reported Scale That is Widely Used in Studies of Children With Fibromyalgia. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
- Multidimensional Anxiety Scale for Children is a Self-report Inventory That Assesses Four Areas of Anxiety Symptoms. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
- Fibromyalgia Impact Questionnaire Modified for Children is a Self-report Instrument That Measures Function, Pain, Fatigue, Sleep Quality, Stiffness, Anxiety and Depression. [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
fluoxetine po 10-60 mg/day for 12 weeks
Other Name: ProzacDrug: Fluoxetine
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.
Other Name: Prozac
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.
|United States, Ohio|
|Women's Health Research Program|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Lesley M Arnold, M.D.||Women's Health Research Program|