drugset / Trial / NCT00463242

A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

NCT00463242

Phase 3 Completed 501 enrolled Novartis
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Timeline

Start
2007-03
Primary completion
2008-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Agomelatine Small molecule 25 mg Oral
Subject Agomelatine Small molecule 50 mg Oral
Comparator Paroxetine Small molecule