Efficacy of MI078 Capsules in Treating Postpartum Depression
NCT06963580 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-08-26
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.
Conditions
Interventions
- 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 for 3 days
Sponsors & Collaborators
-
Nanjing Minova Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
huafang Li · Shanghai Mental Health Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-09
- Primary Completion
- 2025-10-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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