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

University of Pennsylvania22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

24-hour Activity Level

Time frame: Baseline and Week One of Treatment

Secondary Outcomes

Functional Symptom Questionnaire

Time frame: Baseline; Week 6 and Week 8 of Treatment