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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: S 20098

Criteria

Inclusion Criteria:

• Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria

• HAM-D17 total score > or = 22 at Screening and Baseline

• CGI-Severity score > or = 4 at Screening and Baseline

• Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion Criteria:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder

• Any current Axis I disorder other than major depressive disorder which is the focus of treatment

• Substance or alcohol abuse in the last 30 days, dependence in the last 6 months

• Concomitant psychotropic medication, including herbal preparations and melatonin

• Psychotherapy of any type

• Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply