Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

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

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).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Juvenile Primary Fibromyalgia Syndrome (JPFS)
• Intervention / Treatment: Drug: Fluoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Women's Health Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Severity Score	The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale. (0=no pain and 100 = severe pain )	Daily on average in the past week.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Clinical Global Impression of Severity	Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).	at the time of the assessment
The Patient Global Impression of Improvement	Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).	since baseline, at the time of the assessment
The Functional Disability Inventory-child Version	A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).	Over the "last few days."
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 daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).	Over the "last few days."
Children's Depression Inventory	A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.	Over the past 2 weeks.
Multidimensional Anxiety Scale for Children	A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).	Over the past week.
Fibromyalgia Impact Questionnaire Modified for Children	A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).	Over the past week.

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Lesley M Arnold, M.D., Women's Health Research Program

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 26, 2005
• First Submitted That Met QC Criteria: June 26, 2005
• First Posted (Estimate): June 27, 2005

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Fibromyalgia; Juvenile
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 05-3-22-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No