A Study to Evaluate Efficacy and Safety of GW117 Tablets in Major Depressive Disorder

Phase 2 Completed 280 enrolled Beijing Greatway Pharmaceutical Technology Co.,Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study aims to evaluate the efficacy and safety of GW117 Tablets compared to placebo in adults participants with MDD over a period of 8 weeks.

Timeline

Start: 2022-07-07
Primary completion: 2023-09-28
Completion: 2023-10-12

Outcome

Missed primary endpoint

paper However, these differences did not reach statistical significance, potentially due to a high placebo response and other contributing factors. PMID 41425080 ↗

Publications

Shen Y, Hao X, Shi X, Tao Z, Yu X, Wang X, Di X, Yang H, Zhang Y, Li J, Wang Z, Zhang G, Wang J, Jiang Z, Wang R, Liu J, Dong Z, Gu W, Zhang H. Efficacy and safety of GW117 tablets in major depressive disorder: a randomised, double-blind, placebo-controlled, phase 2 dose-finding study. Gen Psychiatr. 2025 Dec 17;38(6):e102337. doi: 10.1136/gpsych-2025-102337. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GW117	Unknown	20 mg	Oral
Subject	GW117	Unknown	40 mg	Oral
Subject	GW117	Unknown	60 mg	Oral