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Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115804
First Posted: June 27, 2005
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati
June 26, 2005
June 27, 2005
November 7, 2012
February 15, 2013
February 10, 2017
June 2005
February 2011   (Final data collection date for primary outcome measure)
Average Pain Severity Score [ Time Frame: Daily on average in the past week. ]

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 )

Severity of pain from the 100-mm visual analog scale of the Pediatric Pain Questionnaire
Complete list of historical versions of study NCT00115804 on ClinicalTrials.gov Archive Site
  • The Clinical Global Impression of Severity [ Time Frame: at the time of the assessment ]
    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).
  • The Patient Global Impression of Improvement [ Time Frame: since baseline, at the time of the assessment ]
    Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).
  • The Functional Disability Inventory-child Version [ Time Frame: Over the "last few days." ]
    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).
  • The Functional Disability Inventory-parent Version [ Time Frame: Over the "last few days." ]
    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).
  • Children's Depression Inventory [ Time Frame: Over the past 2 weeks. ]
    A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.
  • Multidimensional Anxiety Scale for Children [ Time Frame: Over the past week. ]
    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).
  • Fibromyalgia Impact Questionnaire Modified for Children [ Time Frame: Over the past week. ]
    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).
  • 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.
Not Provided
Not Provided
 
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).
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
  • Juvenile Primary Fibromyalgia Syndrome (JPFS)
  • Fibromyalgia
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 Name: Prozac
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.
Intervention: Drug: Fluoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00115804
05-3-22-1
No
Not Provided
Plan to Share IPD: No
Lesley M. Arnold, M.D., University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Lesley M Arnold, M.D. Women's Health Research Program
University of Cincinnati
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP