A Study of MI078 for Postpartum Depression

NCT07721961 | Recruiting Phase 3

• 1 other identifier: No. (118)-2026245FS-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 36

Brief 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.

Conditions

Postpartum Depression (PPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in the CGI-S score

  up to day 31

• HAM-D17 response

  up to day 31

• HAM-D17 remission

  up to day 31

• Clinical Global Impression - Improvement (CGI-I) scale positive response

  up to day 31

• Change from baseline in MADRS total score

  up to day 31

Other Outcomes (6)

• Number of participants with treatment-emergent adverse events (TEAEs)

  up to day 31

• Number of participants with Serious Adverse Events (SAEs)

  up to day 31

• Change from baseline in PR interval，QRS duration, QT interval and Fridericia-corrected QT interval (QTcF)

  up to day 31

Study Arms (2)

MI078 capsule

EXPERIMENTAL

MI078 capsules

Drug: MI078 capsule

placebo

PLACEBO COMPARATOR

Placebo of MI078 capsules

Drug: Placebo of MI078 capsules

Interventions

MI078 capsule DRUG

MI078 capsule for 3 days

MI078 capsule

Placebo of MI078 capsules DRUG

Placebo for 3days

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Minova Pharmaceutical Co., Ltd.: lead

Study Sites (36)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Chongqing Three Gorges Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Xiamen Xianyue Hospital

Xiamen, Fujian, China

RECRUITING

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

RECRUITING

Zhaoqing Third People's Hospital

Zhaoqing, Guangdong, China

RECRUITING

Guangxi Zhuang Autonomous Region Brain Hospital

Liuzhou, Guangxi, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

RECRUITING

Hainan Anning Hospital

Haikou, Hainan, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Shiyan Taihe Hospital

Shiyan, Hebei, China

RECRUITING

Xingtai People's Hospital

Xingtai, Hebei, China

RECRUITING

The Second Affiliated Hospital of Xinxiang Medical University (Henan Mental Health)

Xinxiang, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Zhengzhou Ninth People's Hospital

Zhengzhou, Henan, China

RECRUITING

Zhumadian Psychiatric Hospital

Zhumadian, Henan, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Hunan Brain Hospital

Changsha, Hunan, China

RECRUITING

Zhuzhou Third Hospital (Zhuzhou Psychiatric Hospital)

Zhuzhou, Hunan, China

RECRUITING

Wuxi Mental Health Center

Wuxi, Jiangsu, China

RECRUITING

Xuzhou Dongfang Hospital

Xuzhou, Jiangsu, China

RECRUITING

Ganzhou Third People's Hospital

Ganzhou, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Shandong Daizhuang Hospital

Jining, Shandong, China

RECRUITING

Linfen Central Hospital

Linfen, Shanxi, China

RECRUITING

Xi'an Mental Health Center

Xi’an, Shanxi, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

RECRUITING

Huzhou Third People's Hospital

Huzhou, Zhejiang, China

RECRUITING

Kangning Hospital Affiliated to Ningbo University

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Beijing Anding Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Huilongguan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• gang Wang

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cuixia zhang

CONTACT

025-86667819; zhangcuixia@mnvpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 23, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (36)