The extended-release pill ansofaxine (LY03005) is a possible triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. For a study, researchers sought to examine the effectiveness, safety, and dose of ansofaxine for the treatment of the major depressive disorder (MDD). A multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study was done. For 6 weeks, eligible patients with MDD (18–65 years) were randomly randomized to receive fixed-dose ansofaxine extended-release tablets (40, 80, 120, or 160 mg/d) or a placebo. The primary outcome measure was the change in the total Hamilton Depression Rating Scale score from baseline to week 6.
From October 2015 to September 2017, a total of 260 participants were enrolled, with 255 receiving the study medicine in the following doses: 40 mg (n=52), 80 mg (n=52), 120 mg (n=51), and 160 mg (n=51) ansofaxine and placebo (n=49). At week 6, there were significant differences in mean changes in 17-item Hamilton Depression Rating Scale total scores between the four ansofaxine groups and placebo (12.46; 2=9.71, P=.0447). All dosages of ansofaxine were well tolerated. Treatment-related adverse events occurred in 141 patients (303 instances), with incidence rates of 51.92%, 65.38%, 56.86%, and 62.75% in the 40-, 80-, 120-, and 160-mg ansofaxine groups, and 38.78% in the placebo group. In a controlled context, active doses of ansofaxine (40, 80, 120, and 160 mg/d) were shown to be safe, tolerable, and effective in reducing depressive symptoms in patients with MDD.