Trial Outcomes & Findings for Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia (NCT NCT00115804)

NCT ID: NCT00115804

Last Updated: 2017-02-10

Results Overview

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 )

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6 participants
• Primary outcome timeframe: Daily on average in the past week.
• Results posted on: 2017-02-10

Participant Flow

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.

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

Participant milestones

Measure	Fluoxetine All patients receiving Fluoxetine starting at 10 mg/day
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Fluoxetine All patients receiving Fluoxetine starting at 10 mg/day
Overall Study Adverse Event	2

Baseline Characteristics

Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia

Baseline characteristics by cohort

Measure	Fluoxetine n=6 Participants All eligible patients were given fluoxetine
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.3 years STANDARD_DEVIATION 1.25 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Average Pain Severity	62 mm n=5 Participants

PRIMARY outcome

Timeframe: Daily on average in the past week.

Population: 6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).

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 )

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Average Pain Severity Score	62 mm Standard Deviation 11.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
The Clinical Global Impression of Severity	5 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
The Patient Global Impression of Improvement	1.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
The Functional Disability Inventory-child Version	24.2 units on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
The Functional Disability Inventory-parent Version	19.2 units on a scale Standard Deviation 12.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Children's Depression Inventory	14.2 units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Multidimensional Anxiety Scale for Children	52 units on a scale Standard Deviation 30.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Fluoxetine n=4 Participants Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Fibromyalgia Impact Questionnaire Modified for Children	55.1 units on a scale Standard Deviation 23.3

Adverse Events

Fluoxetine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluoxetine n=6 participants at risk Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Gastrointestinal disorders Viral Adenitis	16.7% 1/6 • Number of events 1 • 12 weeks Period after screening when fluoxetine was started

Other adverse events

Measure	Fluoxetine n=6 participants at risk Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 • 12 weeks Period after screening when fluoxetine was started

Additional Information

Dr. Lesley Arnold

University of Cincinnati

Phone: 513-475-8110

Email: lesley.arnold@uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place