At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6 enrolled
Drug / intervention
Fluoxetinedrug
Likely dose
Fluoxetine 10-60 mg orally once daily for 12 weeks, flexibly dosedAI-extracted
Key inclusion· 3
- ✓Age 13 to 18 years, male or female, outpatient status
- ✓Meets American College of Rheumatology (ACR) criteria for primary fibromyalgia
- ✓Able to understand and cooperate with study procedures
Key exclusion· 8
- ✕Lifetime history of psychosis, hypomania, or mania
- ✕Alcohol or substance abuse/dependence within 6 months before screening
- ✕Serious suicide or homicide risk
- ✕Pregnant, lactating, or female of childbearing potential not using contraception
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome
In Brief
A Phase 3 clinical trial evaluating Fluoxetine for Juvenile Primary Fibromyalgia Syndrome (JPFS) and Fibromyalgia. Completed, enrolled 6 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedJun 2005
Primary CompletionFeb 2011
TodayJul 2026
First PostedJun 27, 2005
Enrollment StartJun 1, 2005
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 21.0 years ago
Interventions
Fluoxetinedrug
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