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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
Sponsor:
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Juvenile Primary Fibromyalgia Syndrome (JPFS)
Fibromyalgia
Intervention Drug: Fluoxetine
Enrollment 6

Recruitment Details 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.
Pre-assignment Details Patients who met entry criteria for juvenile fibromyalgia but did not meet any exclusion criteria.
Arm/Group Title Fluoxetine
Hide Arm/Group Description All patients receiving Fluoxetine starting at 10 mg/day
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Fluoxetine
Hide Arm/Group Description All eligible patients were given fluoxetine
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
6
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
15.3  (1.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
Average Pain Severity   [1] 
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 6 participants
62
(47 to 76)
[1]
Measure 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.”
1.Primary Outcome
Title Average Pain Severity Score
Hide Description

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 )

Time Frame Daily on average in the past week.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: mm
62  (11.9)
2.Secondary Outcome
Title The Clinical Global Impression of Severity
Hide 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).
Time Frame at the time of the assessment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group 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.

Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks

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.

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
5  (1.1)
3.Secondary Outcome
Title The Patient Global Impression of Improvement
Hide Description Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).
Time Frame since baseline, at the time of the assessment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (0.5)
4.Secondary Outcome
Title The Functional Disability Inventory-child Version
Hide 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).
Time Frame Over the "last few days."
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.2  (12.5)
5.Secondary Outcome
Title The Functional Disability Inventory-parent Version
Hide 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).
Time Frame Over the "last few days."
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.2  (12.4)
6.Secondary Outcome
Title Children's Depression Inventory
Hide Description A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.
Time Frame Over the past 2 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.2  (10.3)
7.Secondary Outcome
Title Multidimensional Anxiety Scale for Children
Hide 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).
Time Frame Over the past week.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
52  (30.9)
8.Secondary Outcome
Title Fibromyalgia Impact Questionnaire Modified for Children
Hide 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).
Time Frame Over the past week.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine
Hide Arm/Group Description:
All patients receiving Fluoxetine starting at 10 mg/day
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.1  (23.3)
Time Frame 12 weeks
Adverse Event Reporting Description Period after screening when fluoxetine was started
 
Arm/Group Title Fluoxetine
Hide Arm/Group Description Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
All-Cause Mortality
Fluoxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Gastrointestinal disorders   
Viral Adenitis  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Fluoxetine
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Nervous system disorders   
Headache  1  1/6 (16.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Lesley Arnold
Organization: University of Cincinnati
Phone: 513-475-8110
Responsible Party: Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier: NCT00115804     History of Changes
Other Study ID Numbers: 05-3-22-1
First Submitted: June 26, 2005
First Posted: June 27, 2005
Results First Submitted: November 7, 2012
Results First Posted: February 15, 2013
Last Update Posted: February 10, 2017