NCT00411099

Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	agomelatine
DRUG	placebo

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-01-01
• First posted: 2006-12-13
• Last updated: 2020-12-23

Locations

44 sites across 2 countries: United States, Puerto Rico