Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD

This was a multi-center, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, flexible-dose phase III clinical trial of Buagafuran capsules. The stratification factor was the presence or absence of new generalized anxiety disorder (GAD) (new GAD vs. Non-new GAD). Qualified subjects, according to the ratio of 2:2:1, were randomized into experimental group, placebo-control group and positive-control group, and received a treatment course of 8 weeks. Participants were followed from baseline outpatient visit until end of the follow-up period( 10 weeks and 7 visits in total). The dose of Buagafuran capsules/ Buagafuran capsules mimic can be adjusted from 60mg/ day to 120mg/ day according to treatment needs and tolerance in the follow-up period( at week 1, week 2, and week 4), and the dose of Buspirone tablets/ Buspirone tablets mimic can be adjusted from 10mg/ day to 20mg/ day at the same time.