CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 840 enrolled
Drug / intervention
Duloxetine Hydrochloride +1 moredrug
Likely dose
Duloxetine Hydrochloride 120 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/NCT00810069
NCT00810069Phase 4Completed
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Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

Eli Lilly and Company·interventional·Posted Dec 17, 2008·Updated Jun 21, 2011

In Brief

A Phase 4 clinical trial evaluating Duloxetine Hydrochloride and Escitalopram for Major Depressive Disorder. Completed, enrolled 840 participants across 60 sites in 11 countries.

Detailed Summary

This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested: 1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy 2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesDenmark, France, Greece, Hungary, Italy, Netherlands, Romania, Slovenia, Spain, Sweden, Turkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2008
Enrollment StartNov 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.5 years ago

Interventions

Duloxetine Hydrochloridedrug

Flexible dose of 60 or 120 mg daily

Escitalopramdrug

10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.