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

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University of Pennsylvania

Status and phase

Completed
Phase 4

Conditions

Major Depressive Disorder
Soft Tissue Discomfort Syndrome
Pain

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01035073
F1J-US-X018

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Duloxetine
Experimental group
Treatment:
Drug: Duloxetine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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