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Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

NCT00375973 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-08-21

Study results available
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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).

Conditions

  • Fatigue Syndrome, Chronic

Interventions

DRUG

Duloxetine

Duloxetine po 60-120 mg/day for 12 weeks

DRUG

Placebo

Sugar pill dose comparable to duloxetine

Sponsors & Collaborators

Principal Investigators

  • Lesley M Arnold, MD · University of Cincinnati Women's Health Research Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2012-06-30
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375973 on ClinicalTrials.gov