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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jay Amsterdam, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01035073
First received: December 17, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Soft Tissue Discomfort Syndrome
Pain
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 24-hour activity level [ Time Frame: Baseline and Week One of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Symptom Questionnaire [ Time Frame: Baseline; Week 6 and Week 8 of Treatment ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine Drug: Duloxetine
30-60 mg daily for 8 weeks
Other Name: Cymbalta

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035073

Locations
United States, Pennsylvania
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
Eli Lilly and Company
Investigators
Principal Investigator: Jay D Amsterdam, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Jay Amsterdam, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01035073     History of Changes
Other Study ID Numbers: F1J-US-X018
Study First Received: December 17, 2009
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Syndrome
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Duloxetine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014