The study is in addition to the companies’ joint Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD.
The RENAISSANCE Program is designed to support a new drug application filing planned for the second half of 2012 and a marketing authorization application filing in Europe planned for 2015.
The primary outcome measure for the study is change from double-blind baseline at the end of the dosing period for TC-5214 on the Montgomery-Asberg Depression Rating Scale (MADRS) as compared to placebo.