drugset / Trial / NCT00666757

A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

NCT00666757 ↗

Phase 4 Completed 750 enrolled Eli Lilly and Company Boehringer Ingelheim · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.

Timeline

Start
2008-05
Primary completion
2009-02
Completion
2009-03

Outcome

Missed primary endpoint

paper The primary outcome, remission at week 12 by QIDS-SR, was numerically greater for duloxetine compared with SSRIs (36 vs. 32%), but this difference was not statistically significant. PMID 22027844 ↗

paper Remission superiority on the QIDS-SR was not achieved. PMID 22027844 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Citalopram Small molecule 20 mg Oral
Comparator Citalopram Small molecule 40 mg Oral
Subject Duloxetine Small molecule 30 mg Oral
Subject Duloxetine Small molecule 120 mg Oral
Comparator Fluoxetine Small molecule 20 mg Oral
Comparator Fluoxetine Small molecule 80 mg Oral
Comparator Paroxetine Small molecule 20 mg Oral
Comparator Paroxetine Small molecule 50 mg Oral
Comparator Sertraline Small molecule 50 mg Oral
Comparator Sertraline Small molecule 200 mg Oral

Indications