Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT00115804
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 68
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia	Drug: Fluoxetine	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Treatment
• Official Title: An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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. 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 Names: Prozac

Outcome Measures

Primary Outcome Measures

1. Average Pain Severity Score [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 )

Secondary Outcome Measures

1. The Clinical Global Impression of Severity [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).

2. The Patient Global Impression of Improvement [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).

3. The Functional Disability Inventory-child Version [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).

4. The Functional Disability Inventory-parent Version [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).

5. Children's Depression Inventory [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.

6. Multidimensional Anxiety Scale for Children [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).

7. Fibromyalgia Impact Questionnaire Modified for Children [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lesley M. Arnold, M.D., Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT00115804
• Other Study ID Numbers: 05-3-22-1
• First Posted: Jun 27, 2005
• Last Update Posted: Feb 10, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lesley M. Arnold, M.D., Professor, University of Cincinnati: Fibromyalgia; Juvenile
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome; Fluoxetine

Study Results

Participant Flow

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 Detail	Patients who met entry criteria for juvenile fibromyalgia but did not meet any exclusion criteria.

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Period Title: Overall Study
STARTED	6
COMPLETED	4
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Fluoxetine
Arm/Group Description	All eligible patients were given fluoxetine
Overall Participants	6
Age (Count of Participants)
<=18 years	6 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.3 (1.25)
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%
Average Pain Severity (mm) [Mean (Full Range) ]
Mean (Full Range) [mm]	62

Outcome Measures

1. Primary Outcome

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. (0=no pain and 100 = severe pain )
Time Frame	Daily on average in the past week.

Outcome Measure Data

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
Arm/Group Description	Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Measure Participants	4
Mean (Standard Deviation) [mm]	62 (11.9)

2. Secondary Outcome

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).
Time Frame	at the time of the assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
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.
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	5 (1.1)

3. Secondary Outcome

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).
Time Frame	since baseline, at the time of the assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	1.5 (0.5)

4. Secondary Outcome

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).
Time Frame	Over the "last few days."

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	24.2 (12.5)

5. Secondary Outcome

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).
Time Frame	Over the "last few days."

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	19.2 (12.4)

6. Secondary Outcome

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.
Time Frame	Over the past 2 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	14.2 (10.3)

7. Secondary Outcome

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).
Time Frame	Over the past week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	52 (30.9)

8. Secondary Outcome

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).
Time Frame	Over the past week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoxetine
Arm/Group Description	All patients receiving Fluoxetine starting at 10 mg/day
Measure Participants	4
Mean (Standard Deviation) [units on a scale]	55.1 (23.3)

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Period after screening when fluoxetine was started
Arm/Group Title	Fluoxetine
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fluoxetine
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Gastrointestinal disorders
Viral Adenitis	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Fluoxetine
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Nervous system disorders
Headache	1/6 (16.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.