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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duloxetine

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

30-60 mg daily for 8 weeks

Interventions

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Duloxetine

30-60 mg daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No