drugset / Trial / NCT01035073

Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

NCT01035073

NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Timeline

Start
2006-04
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 30 mg
Subject Duloxetine Small molecule 60 mg