Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: S 20098

Criteria

Inclusion Criteria:

• Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.

• Current episode ≥4 weeks.

• CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.

• Any other current Axis I disorder other than MDD 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.

• Prior exposure to agomelatine.

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

Other protocol-defined inclusion/exclusion criteria may apply