Skip to main content
OpenTrials
Completed

NCT Number: NCT01035073

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Soft Tissue Discomfort Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Depression Research Unit, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104-3309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

30-60 mg daily for 8 weeks

Other names: Cymbalta

Primary outcomes

  1. 24-hour Activity Level

    Time frame: Baseline and Week One of Treatment

Secondary outcomes

  1. Functional Symptom Questionnaire

    Time frame: Baseline; Week 6 and Week 8 of Treatment

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 18, 2009
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.