Efficacy and safety of GW117 tablets in major depressive disorder: a randomised, double-blind, placebo-controlled, phase 2 dose-finding study.

ABSTRACT:

Background

GW117 (N-(2-(6-chloro-7-deuteromethoxy-naphthalen-1-yl) ethyl) acetamide) is a dual-acting agent (MT1/MT2 agonist, 5-HT_2C antagonist) with prior evidence of antidepressant efficacy and favourable safety.

Aims

To preliminarily evaluate the efficacy and safety of GW117 in major depressive disorder (MDD) and to explore the optimal dosing.

Methods

A total of 280 eligible patients aged 18-65 years with MDD were randomly assigned (1:1:1:1) to 8 weeks of double-blind treatment with fixed doses of GW117 tablets (20, 40, 60 mg/day) or placebo. The primary endpoint was the change from baseline to Week 8 in the total score of the Hamilton Rating Scale for Depression-17 item (HAMD-17). Key secondary endpoints included changes in the Montgomery-Åsberg Depress

SUBMITTER: Shen Y 

PROVIDER: S-EPMC12716496 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature