Efficacy, Safety, and Tolerability of Ansofaxine (LY03005) Extended-Release Tablet for Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2 Clinical Trial

• Published in: The international journal of neuropsychopharmacology Vol. 25; no. 3; pp. 252 - 260
• Main Authors: Mi, Weifeng, Yang, Fude, Li, Huafang, Xu, Xiufeng, Li, Lehua, Tan, Qingrong, Wang, Guoqiang, Zhang, Kerang, Tian, Feng, Luo, Jiong, Xia, Jielai, Yuan, Kai, Lu, Lin, Deng, Jiahui, Tian, Jingwei, Zhang, Hongyan
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 17.03.2022
• Subjects: Antidepressants; Drug therapy; Major depressive disorder; Patient outcomes; Physiological aspects; Regular s; Testing; China; Phase 2 Clinical Trial; major depressive disorder; Ansofaxine
• ISSN: 1461-1457; 1469-5111
• DOI: 10.1093/ijnp/pyab074

Abstract Background Ansofaxine (LY03005) extended-release tablet is a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. This study assessed the efficacy, safety, and appropriate dosage of ansofaxine for the treatment of major depressive disorder (MDD). Methods A multicenter, randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial was conducted in China. Eligible patients with MDD (18–65 years) were randomly assigned to receive fixed-dose ansofaxine extended-release tablets (40, 80, 120, or 160 mg/d) or placebo for 6 weeks. The primary outcome measure was a change in the total score on the 17-item Hamilton Depression Rating Scale from baseline to week 6. Results A total of 260 patients were recruited from October 2015 to September 2017, and 255 patients received the study drug as follows: 40 mg (n = 52), 80 mg (n = 52), 120 mg (n = 51), and 160 mg (n = 51) ansofaxine and placebo (n = 49). Significant differences were found in mean changes in 17-item Hamilton Depression Rating Scale total scores at week 6 in the 4 ansofaxine groups vs placebo (−12.46; χ2 = −9.71, P = .0447). All doses of ansofaxine were generally well-tolerated. Treatment-related adverse events occurred in 141 patients (303 cases), yielding 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. Conclusion Active doses (40, 80, 120, and 160 mg/d) of ansofaxine in a controlled setting were safe, tolerated, and effective in improving depression symptoms in MDD patients.