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

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

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 Overview

• Status: Completed
• Conditions: Pain; Major Depressive Disorder; Soft Tissue Discomfort Syndrome
• Intervention / Treatment: Drug: Duloxetine

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3309
      • Depression Research Unit, University of Pennsylvania School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duloxetine	Drug: Duloxetine; 30-60 mg daily for 8 weeks; Other Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24-hour Activity Level	Baseline and Week One of Treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional Symptom Questionnaire	Baseline; Week 6 and Week 8 of Treatment

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Jay D Amsterdam, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 17, 2009
• First Posted (Estimate): December 18, 2009

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Disease; Depressive Disorder; Syndrome; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: F1J-US-X018