A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

Summary

The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS score, as compared to placebo (no medicine) in participants with Major Depressive Disorder (MDD)

Timeline

Start

2018-12-05

Primary completion

2020-12-24

Completion

2020-12-24

Publications

• Mi W, Di X, Wang Y, Li H, Xu X, Li L, Wang H, Wang G, Zhang K, Tian F, Luo J, Yang C, Zhou Y, Xie S, Zhong H, Wu B, Yang D, Chen Z, Li Y, Chen J, Lv S, Yi Q, Jiang Z, Tian J, Zhang H. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder. Transl Psychiatry. 2023 May 10;13(1):163. doi: 10.1038/s41398-023-02435-0.

Drugs

Indications