Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00115804|
Recruitment Status : Completed
First Posted : June 27, 2005
Results First Posted : February 15, 2013
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Primary Fibromyalgia Syndrome (JPFS) Fibromyalgia||Drug: Fluoxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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. 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
- 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 )
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115804
|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|