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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• > 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

Exclusion Criteria:

• 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