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Clinical Trials/NCT01035073
NCT01035073
Completed
Phase 4

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

University of Pennsylvania1 site in 1 country22 target enrollmentApril 2006
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ConditionsMajor Depressive DisorderSoft Tissue Discomfort SyndromePain
InterventionsDuloxetine
DrugsDuloxetine

Overview

Phase
Phase 4
Intervention
Duloxetine
Conditions
Major Depressive Disorder
Sponsor
University of Pennsylvania
Enrollment
22
Locations
1
Primary Endpoint
24-hour Activity Level
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
May 2009
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Duloxetine

Intervention: Duloxetine

Outcomes

Primary Outcomes

24-hour Activity Level

Time Frame: Baseline and Week One of Treatment

Secondary Outcomes

  • Functional Symptom Questionnaire(Baseline; Week 6 and Week 8 of Treatment)

Study Sites (1)

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