RecruitingPhase 3

A Study of MI078 for Postpartum Depression

China200 participantsStarted 2026-07-10

Plain-language summary

This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients aged 18-45 years (inclusive) with a body mass index (BMI) of 18.5-37.0 kg/m² (inclusive). * Based on the investigator's clinical evaluation, the participant meets the diagnostic criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by clinical assessment and the Mini-International Neuropsychiatric Interview (M.I.N.I.), with onset of depression between gestational week 28 and 4 weeks postpartum (inclusive). * Within 12 months postpartum at baseline. * Total score ≥26 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at both screening and baseline. * Understand and voluntarily participate in this trial, agree to comply with all study requirements, and provide written informed consent prior to any study-specific procedures. * Able to communicate well with the investigator, willing and able to comply with lifestyle restrictions or requirements specified in the protocol, and capable of completing the trial as required. Exclusion Criteria: * Currently meeting diagnostic criteria for other DSM-5 psychiatric disorders, as assessed by the investigator. * History of bipolar disorder, schizophrenia, and/or schizoaffective disorder. * Reduction in HAM-D17 total score from screening to baseline ≥25%. * Presence of suicidal ideation/intent, or HAM-D17 Item 3 (suicide) score \>3, or a "yes" response to Item 4 or 5 of the Columbia-Suicide Severity R…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring improvement in PPD symptoms using something called the HAM-D17 score — can you explain what that scale measures and what a meaningful change would look like for someone in my situation?
2Since this is a Phase 3 trial for MI078, what is already known about its safety and effectiveness from earlier studies, and how does that compare to treatments that are already approved for postpartum depression?
3The trial is currently recruiting — before I even consider whether to look into this, do you think my current symptoms and how recently I gave birth would make this worth discussing further with the research team?
4How does the time commitment and any required visits for a Phase 3 trial like this fit with the demands of caring for a newborn, and is that something families have been able to manage realistically?
5If I were to explore this trial and then decide it's not right for me, would I still have access to standard postpartum depression treatments without any delays or gaps in care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in HAM-D17 total score

Timeframe: up to day 31

Trial details

NCT IDNCT07721961

SponsorNanjing Minova Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

cuixia zhang

025-86667819 zhangcuixia@mnvpharma.com

View on ClinicalTrials.gov More Postpartum Depression (PPD) trials