Clinical trial NCT06963580: Efficacy of MI078 Capsules in Treating Postpartum Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postpartum Depression
Lead sponsor: Nanjing Minova Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in HAM-D17 total score
timeFrame: up to day 31
Secondary outcomes:
measure: HAM-D17 response
timeFrame: up to day 31
measure: HAM-D17 remission
timeFrame: up to day 31
measure: Change from baseline in the CGI-S score
timeFrame: up to day 31
measure: Clinical Global Impression - Improvement (CGI-I) scale positive response
timeFrame: up to day 31
measure: Change from baseline in MADRS total score
timeFrame: up to day 31
measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score
timeFrame: up to day 31
measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
timeFrame: up to day 31
measure: Safety Evaluation Indicators
timeFrame: up to day 31
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Xian Yue Hospital
state: Fujian
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: The People's Hospital of Guizhou Province
state: Guizhou
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area Mental Health Center
state: Shanghai
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated Kangning Hospital of Ningbo University
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: 广东
Study officials:
affiliation: Shanghai Mental Health Center
name: huafang Li
role: STUDY_CHAIR
References: