AstraZeneca and Targacept, Inc. have announced the enrollment of the first patient in the Phase IIb 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 III RENAISSANCE program for TC-5214 as an adjunctive treatment for MDD.
The RENAISSANCE program is designed to support a New Drug Application (NDA) filing in the United States planned for the second half of 2012 and a Marketing Authorisation Application (MAA) filing in Europe planned for 2015. AstraZeneca and Targacept are co-developing TC-5214.
In the Phase IIb 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 enrol approximately 350 patients into the double blind phase from approximately 75 centers worldwide.