CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Duloxetinedrug
Likely dose
Duloxetine 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01035073
NCT01035073Phase 4Completed
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Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms

University of Pennsylvania·interventional·Posted Dec 18, 2009·Updated Apr 16, 2020

In Brief

A Phase 4 clinical trial evaluating Duloxetine for Major Depressive Disorder and 2 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2009
Enrollment StartApr 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.5 years ago

Interventions

Duloxetinedrug

30-60 mg daily for 8 weeks