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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035073
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : July 31, 2012
Eli Lilly and Company
Information provided by (Responsible Party):
Jay Amsterdam, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain Drug: Duloxetine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Duloxetine Drug: Duloxetine
30-60 mg daily for 8 weeks
Other Name: Cymbalta

Primary Outcome Measures :
  1. 24-hour activity level [ Time Frame: Baseline and Week One of Treatment ]

Secondary Outcome Measures :
  1. Functional Symptom Questionnaire [ Time Frame: Baseline; Week 6 and Week 8 of Treatment ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035073

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
Principal Investigator: Jay D Amsterdam, MD University of Pennsylvania

Responsible Party: Jay Amsterdam, Professor, University of Pennsylvania Identifier: NCT01035073     History of Changes
Other Study ID Numbers: F1J-US-X018
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents