Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 major-depressive-disorder
Started Apr 2006
Typical duration for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedResults Posted
Study results publicly available
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
3.1 years
December 17, 2009
April 3, 2020
April 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
24-hour Activity Level
Baseline and Week One of Treatment
Secondary Outcomes (1)
Functional Symptom Questionnaire
Baseline; Week 6 and Week 8 of Treatment
Study Arms (1)
Duloxetine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Eli Lilly and Companycollaborator
Study Sites (1)
Depression Research Unit, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104-3309, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Data is unavailable for the following reasons: investigator has succumb to serious health conditions preventing him from entering data, and study team members no longer work for the university and cannot be reached to input data despite efforts.
Results Point of Contact
- Title
- Tyrone Quarterman
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Jay D Amsterdam, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 18, 2009
Study Start
April 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 16, 2020
Results First Posted
April 16, 2020
Record last verified: 2020-04