Procedures
depression
The study comprised a 1-week screening period and a 8-week double-blind treatment period (DBTP). During the screening period, the patients underwent physical examination, depression scale evaluations, 12-lead ECG, and laboratory examinations.Eligible patients were randomized at a 1:1:1 ratio to ansofaxine 80 mg/da y, 160 mg/day, or placebo group using a minimization random allocation system. The system used baseline MARDS total score, age, and gender as prognostic factors to ensure equilibrium among groups and monitored enrollment and allocated medication using a code matching the assigned medication.Study medication was dispensed ansofaxine 40 and 80 mg tablets and matching placebo tablets, identical in appearance and packaging. Participants would take one tablet of ansofaxine (40 mg) or one matched placebo pill daily in the first week and increase to one tablet of ansofaxine (80 mg) daily (or a matching placebo pill) daily in the second week. From week three to the end of DBTP, participants in the low-dose group administrated 80 mg tablet of ansofaxine and one 80 mg matched placebo pill, the high-dose group administrated two 80 mg tablets of ansofaxine, and the placebo group administrated two 80 mg matched placebo pills(see the electronic supplementary protocol.For every visit, the patients would go through vital signs monitoring, depression scale evaluations, AEs record, and combined medication record. The 12-lead ECG and laboratory examinations would be retaken at the end of week 4 and 8.