text: The FDA approved levomilnacipran for treating major depressive disorder. This approval was based on the results of five clinical trials. The trials included one 10-week phase II and four 8-week phase III. Four of the five trials demonstrated a statistically significant superiority to placebo as measured by the Montgomery–Åsberg Depression Rating Scale. Superiority to placebo was also demonstrated by improvement in the Sheehan Disability Scale.