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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postpartum Depression
• Intervention / Treatment: Drug: MI078 capsule dose 1; Drug: MI078 capsule dose 2; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China, 241000
      • The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100096
      • Beijing HuiLongGuan Hospital
  • Fujian
    • Xiamen, Fujian, China
      • Xiamen Xian Yue Hospital
  • Guangdong
    • Foshan, Guangdong, China, 528308
      • Shunde Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510630
      • The First Affiliated Hospital of Jinan University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Zhuang Autonomous Region People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • The People's Hospital of Guizhou Province
  • Hebei
    • Shijiazhuang, Hebei, China, 050023
      • The First Hospital of Hebei Medical University
    • Xingtai, Hebei, China, 054001
      • Xingtai People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200122
      • Shanghai Mental Health Center
    • Shanghai, Shanghai Municipality, China, 200124
      • Shanghai Pudong New Area Mental Health Center
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Linfen Central Hospital
    • Taiyuan, Shanxi, China, 030001
      • The First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou
    • Ningbo, Zhejiang, China
      • The First Affiliated Hospital of Ningbo University
    • Ningbo, Zhejiang, China, 315201
      • The Affiliated Kangning Hospital of Ningbo University
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Female patients aged 18 to 45 years (inclusive) with a Body Mass Index (BMI) ranging from 18.5 to 37.0 kg/m² (inclusive).
• The patient meets the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-5), based on the investigator's clinical evaluation. The onset of illness must occur between 28 weeks of pregnancy and 4 weeks postpartum (inclusive).
• The patient is within 9 months postpartum during the screening period.
• The total score on the HAMD17 is ≥26 during both the screening and baseline periods.
• The patient understands and voluntarily agrees to participate in the study, consents to comply with all study requirements, and is able to provide written informed consent prior to the initiation of any study-specific procedures.
• The patient is able to communicate effectively with the investigator, is willing and able to adhere to the lifestyle restrictions or requirements specified in the study protocol, and can cooperate fully in completing the trial.

Exclusion Criteria:

• Current diagnosis of another mental disorder according to DSM-5 criteria, as assessed by the investigator
• History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
• History of sleep apnea
• Presence of suicidal ideation/intent, or a score >3 on Item 3 (suicide) of the HAMD17, or a response of "yes" to Item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 6 months, or a history of suicidal behavior within the past year
• Meeting the diagnostic criteria for treatment-resistant depression
• Continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode
• Failure to discontinue psychotropic medications for at least 5 half-lives prior to the use of the study drug.
• Need for concurrent use of other psychotropic medications, such as antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding benzodiazepines), during the trial dosing period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI078 capsule dose 1	Drug: MI078 capsule dose 1; MI078 capsule dose 1 for 3 days
Experimental: MI078 capsule dose 2	Drug: MI078 capsule dose 2; MI078 capsule dose 2 for 3 days
Placebo Comparator: placebo; Placebo of MI078 capsules	Drug: placebo; placebo 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
Safety Evaluation Indicators	Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), clinical laboratory test, 12-lead electrocardiogram (ECG)，C-SSRS，PWC-20	up to day 31

Collaborators and Investigators

• Sponsor: Nanjing Minova Pharmaceutical Co., Ltd.
• Investigators: Study Chair: huafang Li, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: April 1, 2025

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; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 2024-43

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