Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00115804
First received: June 26, 2005
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Juvenile Primary Fibromyalgia Syndrome (JPFS)
Fibromyalgia
Drug: Fluoxetine
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: June 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Prozac
Drug: 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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115804

Locations
United States, Ohio
Women's Health Research Program
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Lesley M Arnold, M.D. Women's Health Research Program
  More Information

No publications provided

Responsible Party: Lesley M. Arnold, M.D., Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00115804     History of Changes
Other Study ID Numbers: 05-3-22-1
Study First Received: June 26, 2005
Results First Received: November 7, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Fibromyalgia
Juvenile

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014