AstraZeneca and Targacept, Inc. today announced initiation of a Phase 2b clinical trial of TC-5214, a nicotinic channel blocker, as a "switch" monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies' Phase 3 RENAISSANCE Program for TC-5214 as an adjunctive treatment for MDD. The RENAISSANCE Program is designed to support a New Drug Application (NDA) filing planned for the second half of 2012 and a Marketing Authorization Application (MAA) filing in Europe planned for 2015. AstraZeneca and Targacept are co-developing TC-5214.
In the Phase 2b study, patients with MDD who do not respond adequately, based on predefined criteria, to initial open label treatment with one of six commonly used SSRI or SNRI antidepressants will be switched to receive either one of two fixed doses of TC-5214, the active control duloxetine or placebo. Dosing in this double blind phase of the study is twice daily for eight weeks. 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. The study is projected to enroll approximately 350 patients into the double blind phase from approximately 75 centers worldwide.
AstraZeneca and Targacept, Inc.