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

Completed · Phase 4

Conditions studied: Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain

In brief

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.

Key facts

Study ID

NCT01035073

Run by

University of Pennsylvania

People needed

22

Starts

2006-04-01

Expected to finish

2009-05-01

Last updated by the study team

2020-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 17 years old
• All races and ethnicity
• DSM IV-TR Axis I diagnosis of MDD
• Co-morbid STDS
• Baseline 17-item Hamilton Depression Rating > 13

You may not qualify if…

• Primary Axis I disorder other than MDD
• History of mania or psychosis
• Actively suicidal
• Required hospitalization
• A alcohol or substance abuse or dependence within the preceding 3 months
• Pregnant or nursing
• Unstable medical condition (other than STDS)
• Narrow-angle glaucoma
• Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use
• Hepatic or renal insufficiency

Where it is running

• Depression Research Unit, University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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