Pfizer announced the completion of a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg BID in comparison to placebo for Smoking Cessation in patients with a past or present diagnosis of Major Depressive Disorder (MDD). The study met its primary and secondary efficacy endpoints. Subjects in the varenicline group had a higher likelihood of quitting at week 12 (primary endpoint) and at week 52 (key secondary endpoint). In addition, psychiatric scales included for safety assessments did not show a difference between varenicline and placebo.
The currently approved Chantix/Champix (varenicline) labeling states that the safety and efficacy of varenicline in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder have not been established. Pfizer developed this study protocol at the request of, and in consultation with, the European Medicines Agency to investigate use of varenicline in patients with MDD.