Shiyan

The trial investigates the use of MI078 capsules to treat postpartum depression in women aged 18 to 45 years. It is a multicenter, randomized, double-blind, placebo-controlled study aiming to assess the efficacy and safety of MI078 for this condition. Participants must have a diagnosis of major depressive disorder with onset during late pregnancy or early postpartum, and a certain level of depression severity as measured by the Hamilton Depression Rating Scale. Participants are randomly assigned to two groups one receiving MI078 capsules and the other receiving a matching placebo. The treatment is taken for 3 days during the treatment period. The study includes a screening phase lasting up to 14 days before treatment, a 4-day treatment period, and a follow-up period lasting until day 31 after treatment begins. During the study, participants will undergo clinical assessments including depression rating scales such as the HAM-D17 and other mood and anxiety scales. Researchers will monitor changes from baseline in depression scores and record safety information throughout the follow-up period. Participants are expected to comply with study requirements, lifestyle restrictions, and attend scheduled visits for evaluations over approximately one month.