NCT00375973

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Chronic fatigue syndrome (CFS) is characterized by severe disabling fatigue of at least six months duration that cannot be fully explained by an identifiable medical condition . Pain symptoms are also a part of the diagnostic criteria for CFS, and include muscle pain, multi-joint pain, and headaches. The prevalence of CFS ranges from 0.007 to 2.8 % in the general adult population and 0.006 to 3.0% in primary care practice (2). Although most who receive a CFS diagnosis are 30-40 years of age, Caucasian, and female, CFS affects both women and men, adults and children, and all racial and socioeconomic classes. Patients with CFS have 2-4 times the rate of depression and anxiety compared with the general population. CFS is also commonly comorbid with fibromyalgia, a disorder characterized by chronic widespread pain, tenderness, fatigue, sleep and mood disturbances. In some samples, 70% of patients with fibromyalgia also meet criteria for CFS. CFS and fibromyalgia are characterized by greater similarities than differences and may share pathophysiologic features. Like fibromyalgia, CFS is associated with chronic pain, sleep and mood disturbances. Because fibromyalgia responds to treatment with antidepressants, particularly the dual serotonin and norepinephrine reuptake inhibitors, including duloxetine, antidepressant trials in CFS are clearly needed.

Conditions

• Fatigue Syndrome, Chronic

Interventions

Type	Name	Description
DRUG	Duloxetine	Duloxetine po 60-120 mg/day for 12 weeks
DRUG	Placebo	Sugar pill dose comparable to duloxetine

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-06-01
• Completion: 2014-03-01
• First posted: 2006-09-13
• Last updated: 2015-08-21
• Results posted: 2015-07-27

Locations

1 site across 1 country: United States