Phase 3 Randomized Trial Evaluating MI078 Capsules in Women with Postpartum Depression Aged 18 to 45

What this Trial Is About

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.

A Study of MI078 for Postpartum Depression