At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Fatigue Syndrome, Chronic. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue Syndrome, Chronic
CountriesUnited States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedSep 2006
Primary CompletionJun 2012
Study CompletionMar 2014
TodayJul 2026
First PostedSep 13, 2006
Enrollment StartSep 1, 2006
Primary CompletionJun 1, 2012
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.8 years ago
Interventions
Duloxetinedrug
Duloxetine po 60-120 mg/day for 12 weeks
Placebodrug
Sugar pill dose comparable to duloxetine