Efficacy of MI078 Capsules in Treating Postpartum Depression
NCT ID: NCT06963580
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2024-09-09
2025-12-31
Brief Summary
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To assess the safety of MI078 capsules in postpartum depression patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MI078 capsule dose 1
MI078 capsule dose 1
MI078 capsule dose 1
MI078 capsule dose 1 for 3 days
MI078 capsule dose 2
MI078 capsule dose 2
MI078 capsule dose 2
MI078 capsule dose 2 for 3 days
placebo
Placebo of MI078 capsules
placebo
placebo for 3 days
Interventions
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MI078 capsule dose 1
MI078 capsule dose 1 for 3 days
MI078 capsule dose 2
MI078 capsule dose 2 for 3 days
placebo
placebo for 3 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Nanjing Minova Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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huafang Li
Role: STUDY_CHAIR
Shanghai Mental Health Center
Locations
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The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital
Wuhu, Anhui, China
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
Xiamen Xian Yue Hospital
Xiamen, Fujian, China
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
The People's Hospital of Guizhou Province
Guiyang, Guizhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated Kangning Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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2024-43
Identifier Type: -
Identifier Source: org_study_id
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