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

Phase 4

Completed

• Conditions: Major Depressive Disorder; Pain; Soft Tissue Discomfort Syndrome
• Interventions: Drug: Duloxetine

• Registration Number: NCT01035073
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Status Verified: 2020-04
• Results First Submitted: 2020-04-03
• Results First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Results First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	-

Primary Outcome Measures

Name	Time	Method
24-hour Activity Level	Baseline and Week One of Treatment

Secondary Outcome Measures

Name	Time	Method
Functional Symptom Questionnaire	Baseline; Week 6 and Week 8 of Treatment

Trial Locations

Locations (1)

Depression Research Unit, University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States