Efficacy of MI078 Capsules in Treating Postpartum Depression

NCT06963580 | Active Not Recruiting Phase 2

• 1 other identifier: 2024-43
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 21

Brief 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

Postpartum Depression

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 (8)

• HAM-D17 response

  up to day 31

• HAM-D17 remission

  up to day 31

• Change from baseline in the CGI-S score

  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

Study Arms (3)

MI078 capsule dose 1

EXPERIMENTAL

MI078 capsule dose 1

Drug: MI078 capsule dose 1

MI078 capsule dose 2

EXPERIMENTAL

MI078 capsule dose 2

Drug: MI078 capsule dose 2

placebo

PLACEBO COMPARATOR

Placebo of MI078 capsules

Drug: placebo

Interventions

MI078 capsule dose 1 DRUG

MI078 capsule dose 1 for 3 days

MI078 capsule dose 1

MI078 capsule dose 2 DRUG

MI078 capsule dose 2 for 3 days

MI078 capsule dose 2

placebo DRUG

placebo for 3 days

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Minova Pharmaceutical Co., Ltd.: lead

Study Sites (21)

The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital

Wuhu, Anhui, 241000, China

Location

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Xiamen Xian Yue Hospital

Xiamen, Fujian, China

Location

Shunde Hospital of Southern Medical University

Foshan, Guangdong, 528308, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 530021, China

Location

The People's Hospital of Guizhou Province

Guiyang, Guizhou, 550002, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 054001, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200122, China

Location

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, 200124, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041000, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

The Affiliated Kangning Hospital of Ningbo University

Ningbo, Zhejiang, 315201, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

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

• huafang Li

  Shanghai Mental Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 28, 2025
• First Posted: May 9, 2025
• Study Start: September 9, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (21)