CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 527 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 30 milligramsfrom 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/NCT01070329
NCT01070329Phase 4Completed

Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms

Eli Lilly and Company·interventional·Posted Feb 18, 2010·Updated Feb 13, 2012

In Brief

A Phase 4 clinical trial evaluating Duloxetine and Placebo for Major Depressive Disorder. Completed, enrolled 527 participants across 34 sites in 2 countries.

Detailed Summary

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.4 years ago

Interventions

Duloxetinedrug

Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.

Placebodrug

Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.