Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

Phase 2/3 Completed 60 enrolled University of Cincinnati Eli Lilly and Company · collab

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2006-09
Primary completion: 2012-06
Completion: 2014-03

Outcome

Missed primary endpoint

paper was not significantly greater than for the placebo group (P = 0.23; PMID 25660434 ↗

paper The primary efficacy measure of general fatigue did not significantly improve with duloxetine when compared with placebo. PMID 25660434 ↗

Publications

Arnold LM, Blom TJ, Welge JA, Mariutto E, Heller A. A randomized, placebo-controlled, double-blinded trial of duloxetine in the treatment of general fatigue in patients with chronic fatigue syndrome. Psychosomatics. 2015 May-Jun;56(3):242-53. doi: 10.1016/j.psym.2014.12.003. Epub 2014 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	Oral
Subject	Duloxetine	Small molecule	120 mg	Oral