Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder
brief summary
This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.
detailed description
This trial consists of two parts: a short-term study and a long-term study. The short-term study adopts a multicenter, randomized, double-blind, double-Dummy parallel-group design, including a 14-day screening period, 6-week double-blind treatment period; the experimental group receives KH607 tablets for 3 weeks, followed by KH607 placebo for 3 weeks; the control group receives vortioxetine hydrobromide tablets for 6 weeks. In the long-term study, participants will return to the study site for follow-up every 4 weeks for up to 24 weeks. Those who do not meet relapse criteria will receive no antidepressant treatment, while participants meeting relapse criteria will be treated with KH607 Tablets for one cycle.
official title
Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KH607 Tablets in the Treatment of Major Depressive Disorder With Vortioxetine Hydrobromide Tablets as the Active Control