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

Major Depressive Disorder (MDD) Clinical Trial

Official title:
A Phase III, A Multicenter, Double-blind, Randomized, Placebo-controlled Study Verify the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets for Major Depressive Disorder

Clinical Trial 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)

Clinical Trial Description

The study consisted of two periods: a screening period of 1 week and a double-blind treatment period (8 weeks). After the screening period, 588 enrolled subjects were randomized into one of 3 study groups in the 1:1:1 ratio, 2 LY03005 treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, followed up at the end of 1, 2, 4 6, and 8 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04853407
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Completed
Phase Phase 3
Start date December 5, 2018
Completion date December 24, 2020
View Details
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