2. Academic Validation
  3. 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

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

  • Int J Neuropsychopharmacol. 2022 Mar 17;25(3):252-260. doi: 10.1093/ijnp/pyab074.
Weifeng Mi 1,  Fude Yang 2,  Huafang Li 3,  Xiufeng Xu 4,  Lehua Li 5,  Qingrong Tan 6,  Guoqiang Wang 7,  Kerang Zhang 8,  Feng Tian 9,  Jiong Luo 10,  Jielai Xia 11,  Kai Yuan 1,  Lin Lu 1,  Jiahui Deng 1,  Jingwei Tian 12,  Hongyan Zhang 1
Affiliations

Affiliations

  • 1 Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
  • 2 Beijing Huilongguan Hospital, Beijing, China.
  • 3 Shanghai Mental Health Center, Shanghai, China.
  • 4 First Affiliated Hospital of Kunming Medical University, Kunming, China.
  • 5 Second Xiangya Hospital of Central South University, Changsha, China.
  • 6 First Affiliated Hospital of the Fourth Military Medical University (Air Force Medical University), Xi'an, China.
  • 7 Wuxi Mental Health Center, Wuxi, China.
  • 8 First Hospital of Shanxi Medical University, Taiyuan, China.
  • 9 Second Hospital of Shanxi Medical University, Taiyuan, China.
  • 10 Beijing Anding Hospital of Capital Medical University, Beijing, China.
  • 11 Fourth Military Medical University of Chinese People's Liberation Army, Statistical Analysis Teaching and Research Section, Xi'an, China.
  • 12 Yantai University, Yantai, China.
PMID: 34747448 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.

Keywords

Ansofaxine; Phase 2 Clinical Trial; major depressive disorder.

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