drugset / Trial / NCT00810069

Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

NCT00810069 ↗

Phase 4 Completed 840 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-11
Primary completion
2010-02
Completion
2010-03

Outcome

Missed primary endpoint

registry Early Intervention vs Delayed Intervention; p = 0.213; Kaplan-Meier Analysis NCT00810069 ↗

registry Early Intervention vs Delayed Intervention; p = 0.075; Kaplan-Meier analysis NCT00810069 ↗

paper Although no differences in the primary end points were found, a higher remission rate was seen with the early switch strategy. PMID 22722513 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg —
Subject Duloxetine Small molecule 120 mg —
Subject Escitalopram Small molecule 10 mg —
Subject Escitalopram Small molecule 20 mg —