CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 483 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 120 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/NCT00985504
NCT00985504Phase 4Completed
CompareCT.gov

A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood

Eli Lilly and Company·interventional·Posted Sep 28, 2009·Updated Dec 13, 2011

In Brief

A Phase 4 clinical trial evaluating Duloxetine and Escitalopram for Major Depressive Disorder. Completed, enrolled 483 participants across 15 sites in 5 countries.

Detailed Summary

The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Canada, Mexico, Russia, Taiwan
CollaboratorsBoehringer Ingelheim

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.8 years ago

Interventions

Duloxetinedrug

60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks.

Escitalopramdrug

10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks.