{"protocolSection":{"identificationModule":{"nctId":"NCT00115804","orgStudyIdInfo":{"id":"05-3-22-1"},"organization":{"fullName":"University of Cincinnati","class":"OTHER"},"briefTitle":"Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia","officialTitle":"An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome"},"statusModule":{"statusVerifiedDate":"2017-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-06"},"primaryCompletionDateStruct":{"date":"2011-02","type":"ACTUAL"},"completionDateStruct":{"date":"2011-02","type":"ACTUAL"},"studyFirstSubmitDate":"2005-06-26","studyFirstSubmitQcDate":"2005-06-26","studyFirstPostDateStruct":{"date":"2005-06-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-11-07","resultsFirstSubmitQcDate":"2013-01-15","resultsFirstPostDateStruct":{"date":"2013-02-15","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-02-06","lastUpdatePostDateStruct":{"date":"2017-02-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Lesley M. Arnold, M.D.","investigatorTitle":"Professor","investigatorAffiliation":"University of Cincinnati"},"leadSponsor":{"name":"University of Cincinnati","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"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).","detailedDescription":"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."},"conditionsModule":{"conditions":["Juvenile Primary Fibromyalgia Syndrome (JPFS)","Fibromyalgia"],"keywords":["Fibromyalgia","Juvenile"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE","maskingDescription":"Open Label"}},"enrollmentInfo":{"count":6,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Fluoxetine","type":"EXPERIMENTAL","description":"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.","interventionNames":["Drug: Fluoxetine"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","description":"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","armGroupLabels":["Fluoxetine"],"otherNames":["Prozac"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Average Pain Severity Score","description":"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale.\n\n(0=no pain and 100 = severe pain )","timeFrame":"Daily on average in the past week."}],"secondaryOutcomes":[{"measure":"The Clinical Global Impression of Severity","description":"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).","timeFrame":"at the time of the assessment"},{"measure":"The Patient Global Impression of Improvement","description":"Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).","timeFrame":"since baseline, at the time of the assessment"},{"measure":"The Functional Disability Inventory-child Version","description":"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).","timeFrame":"Over the \"last few days.\""},{"measure":"The Functional Disability Inventory-parent Version","description":"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).","timeFrame":"Over the \"last few days.\""},{"measure":"Children's Depression Inventory","description":"A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.","timeFrame":"Over the past 2 weeks."},{"measure":"Multidimensional Anxiety Scale for Children","description":"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).","timeFrame":"Over the past week."},{"measure":"Fibromyalgia Impact Questionnaire Modified for Children","description":"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).","timeFrame":"Over the past week."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female or male outpatients 13 to 18 years of age.\n* Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.\n* Ability to understand and cooperate with study procedures.\n* Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.\n\nExclusion Criteria:\n\n* Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.\n* Lifetime history of psychosis, hypomania or mania.\n* Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.\n* Patients judged to be at serious suicide or homicide risk.\n* 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).\n* 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.\n* 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).\n* History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).\n* Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.\n* Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.\n* Treatment with any other excluded medication that cannot be discontinued at the screening visit.\n* Previous treatment with fluoxetine.\n* Treatment with any investigational medications within 30 days prior to screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"13 Years","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lesley M Arnold, M.D.","affiliation":"Women's Health Research Program","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Women's Health Research Program","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients who met entry criteria for juvenile fibromyalgia but did not meet any exclusion criteria.","recruitmentDetails":"Female or male patients from Children's Hospital pediatric outpatient rheumatology clinic were eligible for the trial if they were 13 to 17 years and met study criteria.","groups":[{"id":"FG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Fluoxetine","description":"All eligible patients were given fluoxetine"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.3","spread":"1.25"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}]}]},{"title":"Average Pain Severity","description":"The average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale. This is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of zero \"no pain at all\" and 100 \"worst pain imaginable.\"","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"mm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62","lowerLimit":"47","upperLimit":"76"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Average Pain Severity Score","description":"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale.\n\n(0=no pain and 100 = severe pain )","populationDescription":"6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mm","timeFrame":"Daily on average in the past week.","groups":[{"id":"OG000","title":"Fluoxetine","description":"Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"62","spread":"11.9"}]}]}]},{"type":"SECONDARY","title":"The Clinical Global Impression of Severity","description":"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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"at the time of the assessment","groups":[{"id":"OG000","title":"Fluoxetine","description":"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.\n\nFluoxetine: fluoxetine po 10-60 mg/day for 12 weeks\n\nFluoxetine: 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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"The Patient Global Impression of Improvement","description":"Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"since baseline, at the time of the assessment","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"0.5"}]}]}]},{"type":"SECONDARY","title":"The Functional Disability Inventory-child Version","description":"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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Over the \"last few days.\"","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.2","spread":"12.5"}]}]}]},{"type":"SECONDARY","title":"The Functional Disability Inventory-parent Version","description":"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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Over the \"last few days.\"","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.2","spread":"12.4"}]}]}]},{"type":"SECONDARY","title":"Children's Depression Inventory","description":"A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Over the past 2 weeks.","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.2","spread":"10.3"}]}]}]},{"type":"SECONDARY","title":"Multidimensional Anxiety Scale for Children","description":"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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Over the past week.","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52","spread":"30.9"}]}]}]},{"type":"SECONDARY","title":"Fibromyalgia Impact Questionnaire Modified for Children","description":"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).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Over the past week.","groups":[{"id":"OG000","title":"Fluoxetine","description":"All patients receiving Fluoxetine starting at 10 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55.1","spread":"23.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"12 weeks","description":"Period after screening when fluoxetine was started","eventGroups":[{"id":"EG000","title":"Fluoxetine","description":"Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.","seriousNumAffected":1,"seriousNumAtRisk":6,"otherNumAffected":1,"otherNumAtRisk":6}],"seriousEvents":[{"term":"Viral Adenitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":6}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":6}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Lesley Arnold","organization":"University of Cincinnati","email":"lesley.arnold@uc.edu","phone":"513-475-8110"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D005356","term":"Fibromyalgia"}],"ancestors":[{"id":"D009135","term":"Muscular Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D012216","term":"Rheumatic Diseases"},{"id":"D009468","term":"Neuromuscular Diseases"},{"id":"D009422","term":"Nervous System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D005473","term":"Fluoxetine"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}