An eight-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of agomelatine 0.5 mg and 1 mg sublingual tablets administered once daily in patients with major depressive disorder (MDD)

The purpose of this study is to determine whether a sublingual formulation of agomelatine, at doses of either 0.5 and/or 1 mg/day (compared to placebo), is effective in reducing depressive symptoms in patients with major depressive disorder (MDD). Data from this study will be used to support a registration submission of the sublingual formulation of agomelatine as a treatment for MDD.

This is an eight-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Randomized patients will enter an eight-week treatment period. Visits to assess safety and efficacy are scheduled at one-week intervals for the first two weeks and then at two-week intervals for the next six weeks. Patients who complete all visits of the study may be eligible to enter a 52-week, long-term, open-label study of agomelatine sublingual tablets.

You may be eligible to participate in this study if you:

• Are an adult, 18 through 70 years of age, inclusive
• Had a diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria Appendix 2
• Have had a current episode ≥ 4 weeks

You will be excluded from this study if you:

• Have a history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder
• Have had two or more failed treatment trials with registered antidepressants during the current depressive episode
• Have had prior exposure to agomelatine
• Have a history of hepatic impairment
• Are working outside regular daytime hours

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.