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

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder; Soft Tissue Discomfort Syndrome; Pain

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01035073

F1J-US-X018

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Duloxetine

Experimental group

Treatment:

Drug: Duloxetine