Phase 4 N=22 Treatment

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

Major Depressive Disorder · Soft Tissue Discomfort Syndrome · Pain

Bottom Line

View on ClinicalTrials.gov: NCT01035073 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2020

Primary outcome: Primary: 24-hour Activity Level

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Duloxetine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hour Activity Level	—	—
SECONDARY Functional Symptom Questionnaire	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01035073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.