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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035073
• Other study ID #: F1J-US-X018
• Status: Completed
• Phase: Phase 4
• Start date: April 2006
• Est. completion date: May 2009

Study information

• Verified date: April 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Pain
• Soft Tissue Discomfort Syndrome
• Syndrome

Intervention

Drug:
• Duloxetine
30-60 mg daily for 8 weeks

Locations

Country	Name	City	State
United States	Depression Research Unit, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Activity Level		Baseline and Week One of Treatment
Secondary	Functional Symptom Questionnaire		Baseline; Week 6 and Week 8 of Treatment