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

Primary Purpose

Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Depression Research Unit, University of Pennsylvania School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

Outcomes

Primary Outcome Measures

24-hour Activity Level

Secondary Outcome Measures

Functional Symptom Questionnaire

Full Information

First Posted
December 17, 2009
Last Updated
April 3, 2020
Sponsor
University of Pennsylvania
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01035073
Brief Title
Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome
Official Title
Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
30-60 mg daily for 8 weeks
Primary Outcome Measure Information:
Title
24-hour Activity Level
Time Frame
Baseline and Week One of Treatment
Secondary Outcome Measure Information:
Title
Functional Symptom Questionnaire
Time Frame
Baseline; Week 6 and Week 8 of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay D Amsterdam, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Research Unit, University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.upenn.edu/dru
Description
Depression Research Unit

Learn more about this trial

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

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