A Study of MI078 for Postpartum Depression

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Clinical Trial of MI078 Capsules for the Treatment of Patients With Postpartum Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression (PPD)
• Intervention / Treatment: Drug: MI078 capsule; Drug: Placebo of MI078 capsules

Detailed Description

This study is designed as a multicenter, randomized, double-blind, placebo-controlled parallel-group trial. It plans to enroll two groups - one receiving the investigational drug and the other receiving placebo - with 100 participants per group. The study includes a screening period (Day -14 to Day -1), a treatment period (Days 1 to 4), and a follow-up period (Days 5 to 31). Eligible participants will be randomized in a 1:1 ratio and will take the study drug for a total of 3 days.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: cuixia zhang; Phone Number: 833 025-86667819; Email: zhangcuixia@mnvpharma.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Huilongguan Hospital
    • Contact: Fude Yang
  • Beijing, China
    • Recruiting
    • Beijing Anding Hospital, Capital Medical University
    • Contact: gang Wang
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Feng Geng
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • Chongqing Three Gorges Hospital
      • Contact: Shiyou Tang
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • The Affiliated Hospital of Chongqing Medical University
      • Contact: Lian Du
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • Xiamen Xianyue Hospital
      • Contact: Yan Qiu
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Provincial Hospital of Traditional Chinese Medicine
      • Contact: Shenghui Huang
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Jinan University
    • Zhaoqing, Guangdong, China
      • Recruiting
      • Zhaoqing Third People's Hospital
      • Contact: Guoqiang Cheng
  • Guangxi
    • Liuzhou, Guangxi, China
      • Recruiting
      • Guangxi Zhuang Autonomous Region Brain Hospital
      • Contact: Fang Fang
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guizhou Provincial People's Hospital
      • Contact: Hui Xiang
    • Zunyi, Guizhou, China
      • Recruiting
      • Affiliated Hospital of Zunyi Medical University
      • Contact: Guifang Chen
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Hainan Anning Hospital
      • Contact: Yin Lin
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Xiaona Sheng
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The first Hospital of Hebei Medical University
      • Contact: Cuixia An
    • Shiyan, Hebei, China
      • Recruiting
      • Shiyan Taihe Hospital
      • Contact: Chunqi Ai
    • Xingtai, Hebei, China
      • Recruiting
      • Xingtai People's Hospital
  • Henan
    • Xinxiang, Henan, China
      • Recruiting
      • The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Health)
      • Contact: Ruiling Zhang
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Yihui Hao
    • Zhengzhou, Henan, China
      • Recruiting
      • Zhengzhou Ninth People's Hospital
      • Contact: Xiaojuan Ma
    • Zhumadian, Henan, China
      • Recruiting
      • Zhumadian Psychiatric Hospital
      • Contact: Jingli Wang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Qirong Wan
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Brain Hospital
      • Contact: Ning Yuan
      • Contact: Zhengyu Tang
    • Zhuzhou, Hunan, China
      • Recruiting
      • Zhuzhou Third Hospital (Zhuzhou Psychiatric Hospital)
      • Contact: Xiaoli Liu
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Recruiting
      • Wuxi Mental Health Center
      • Contact: Zhiqiang Wang
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Xuzhou Dongfang Hospital
      • Contact: Shiping Xie
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • Ganzhou Third People's Hospital
      • Contact: Ying Shen
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Ailan Wan
  • Shandong
    • Jining, Shandong, China
      • Recruiting
      • Shandong Daizhuang Hospital
      • Contact: Zengxun Liu
  • Shanxi
    • Linfen, Shanxi, China
      • Recruiting
      • Linfen Central Hospital
      • Contact: Dong Yan
    • Xi’an, Shanxi, China
      • Recruiting
      • Xi'an Mental Health Center
      • Contact: Huali Lin
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Bo Zhou
    • Luzhou, Sichuan, China
      • Recruiting
      • The Affiliated Hospital of Southwest Medical University
      • Contact: Kezhi Liu
  • Zhejiang
    • Huzhou, Zhejiang, China
      • Recruiting
      • Huzhou Third People's Hospital
      • Contact: Zhongxia Shen
    • Ningbo, Zhejiang, China
      • Recruiting
      • The first affiliated hospital of Ningbo university
      • Contact: Yunxin Ji
    • Ningbo, Zhejiang, China
      • Recruiting
      • Kangning Hospital Affiliated to Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Rating Scale (C-SSRS) for suicidal ideation in the past 6 months at baseline, or a history of suicidal behavior within 1 year.
• Meeting diagnostic criteria for treatment-resistant depression.
• Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode.
• Discontinuation of psychotropic medications for less than 5 half-lives prior to the first dose of study drug.
• Need for concomitant use of other psychoactive drugs during the treatment period, including antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding non-benzodiazepines).
• Discontinuation of strong CYP3A4 inducers or inhibitors for less than 5 half-lives prior to the first dose of study drug.
• Receipt of systematic psychotherapy (e.g., interpersonal therapy, psychodynamic therapy, cognitive-behavioral therapy) or psychiatric-related acupuncture within 1 week prior to the first dose, or planned receipt of such treatments during the trial.
• Receipt of other physical treatments for psychiatric disorders (e.g., modified electroconvulsive therapy, transcranial magnetic stimulation, psychiatric-related laser therapy, vagus nerve stimulation, deep brain stimulation, light therapy) within 1 month prior to screening.
• Presence of severe or unstable cardiovascular, hepatic, renal, hematological, endocrine (e.g., uncontrolled hyper- or hypothyroidism), neurological (e.g., epilepsy, Parkinson's disease, multiple sclerosis, Huntington's disease, history of seizure disorder [except single febrile seizure in childhood]), gastrointestinal (e.g., history of gastrointestinal disease or surgery that may interfere with drug absorption, distribution, metabolism, or excretion), or other systemic or organ diseases, as judged by the investigator.
• History of malignancy within 1 year prior to screening.
• Participation in another drug trial within 3 months prior to screening, or participation in a medical device trial within 1 month prior to screening (defined as having received investigational drug or device treatment).
• Major surgery (excluding cesarean section) within 1 month prior to screening, or planned surgery during the trial period.
• History of hypersensitivity (allergy to at least 2 substances) or known allergy to progesterone.
• Positive pregnancy test at screening or baseline (for participants who are 4 weeks postpartum, a positive result requires retesting), or unwillingness to use effective contraception throughout the trial and for at least 3 months after the last dose of study drug, or plans for oocyte donation during this period.
• Clinically significant abnormal 12-lead electrocardiogram (ECG) or laboratory findings at screening or baseline that, in the investigator's opinion, may affect the trial, including but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN), or serum creatinine >1.5× ULN.
• Currently breastfeeding and unwilling to discontinue breastfeeding during the treatment period and for 7 days after the last dose.
• Any physical/psychological illness or condition that, in the investigator's opinion, may increase the risk of the trial, affect compliance with the protocol, or interfere with the completion of the study, or any other condition that the investigator deems unsuitable for participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Placebo of MI078 capsules	Drug: Placebo of MI078 capsules; Placebo for 3days
Experimental: MI078 capsule; MI078 capsules	Drug: MI078 capsule; MI078 capsule for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HAM-D17 total score	The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.	up to day 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAM-D17 response	Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression.	up to day 31
HAM-D17 remission	Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression	up to day 31
Change from baseline in the CGI-S score	The CGI-S scale is a 7-point scale that requires the Investigator to assess how mentally ill is the patient at this time. 1 - normal, not at all ill; 2 - borderline mentally ill; 3 - mildly ill; 4 - moderately ill; 5 - markedly ill; 6 - severely ill; or 7 - among the most extremely ill patients	up to day 31
Clinical Global Impression - Improvement (CGI-I) scale positive response	The CGI-I scale is a 7-point scale that requires the Investigator to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of study drug treatment. 1 - very much improved; 2 - much improved; 3 - minimally improved; 4 - no change; 5 - minimally worse; 6 - much worse; or 7 - very much worse	up to day 31
Change from baseline in MADRS total score	The MADRS contains 10 individual items related to the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The total score ranges from 0 to 60, with higher scores indicating more severe depression	up to day 31
Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score	The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions. The total score ranges from 0 to 30, with higher scores indicating more severe depression.	up to day 31
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score	The HAM-A contains 14 individual ratings related to the following symptoms: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.	up to day 31

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	Adverse events (AEs) will be assessed by type, frequency, severity, and relationship to study drug.	up to day 31
Number of participants with Serious Adverse Events (SAEs)	As defined by ICH-GCP guidelines	up to day 31
Change from baseline in PR interval，QRS duration, QT interval and Fridericia-corrected QT interval (QTcF)	The PR interval ,QRS duration, and QT interval will be measured from the 12-lead electrocardiogram (ECG) and reported in milliseconds (ms),The QT interval corrected for heart rate using Fridericia's formula (QTcF) will be derived from the 12-lead electrocardiogram (ECG) and reported in milliseconds (ms)	up to day 31
Number of participants with suicidal ideation or behavior as assessed by C-SSRS	The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to evaluate suicidal ideation and behavior	up to day 31
Change from baseline in PWC-20 total score	The PWC-20 scale will be used to evaluate the withdrawl reaction	up to day 31
Number of participants with clinically significant laboratory abnormalities	Clinical laboratory tests (including hematology, blood chemistry, and urinalysis) will be assessed. This outcome reports the count of participants with any clinically significant abnormality as judged by the investigator.	up to day 31

Collaborators and Investigators

• Sponsor: Nanjing Minova Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: gang Wang, Beijing Anding Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: No. (118)-2026245FS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No