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

Outcome

Met primary endpoint

paper 80 mg, -20.0; 160 mg, -19.9) vs. placebo (-14.6; p < 0.0001). PMID 37164957 ↗

release “盐 酸 安 舒 法 辛 缓 释 片（LY03005）在 中 国 的Ⅲ期 临 床 试 验 达 到 预 设 终 点.” luye.com ↗

release “LY03005 80mg组 和160mg组8周 末 的 蒙 哥 马 利-艾 斯 伯 格 抑 郁 量 表（MADRS）总 分 较 基 线 的 变 化 值，差 异 在 统 计 学 上 具 有 显 着 意 义（P＜0.0001）” luye.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Toludesvenlafaxine	Small molecule	80 mg	Oral
Subject	Toludesvenlafaxine	Small molecule	160 mg	Oral

Indications