NCT06963580

Efficacy of MI078 Capsules in Treating Postpartum Depression

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of MI078 Capsule in Patients With Postpartum Depression

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Nanjing Minova Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial. It includes three groups. Each group will enroll 24 participants. The trial aims todetermine： To evaluate the efficacy of MI078 capsules in treating postpartum depression and to explore the optimal dosing regimen for MI078 capsules. To assess the safety of MI078 capsules in postpartum depression patients.

Detailed description

This study employs a multicenter, randomized, double-blind, placebo-controlled parallel design. It plans to include three groups: one for the test drug at dose 1, one for the test drug at dose 2, and one for the placebo group, with 24 subjects in each group. The study consists of a screening period (D-14 to D-1), a treatment period (Day 1 to Day 4), and a follow-up period (Day 5 to Day 31). Enrolled subjects will be randomly assigned in a 1:1:1 ratio and will take the study medication for a total of 3 days.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DRUG	MI078 capsule dose 1	MI078 capsule dose 1 for 3 days
DRUG	MI078 capsule dose 2	MI078 capsule dose 2 for 3 days
DRUG	placebo	placebo for 3 days

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-05-09
• Last updated: 2025-08-26

Locations

21 sites across 1 country: China