Status:
ACTIVE_NOT_RECRUITING
Efficacy of MI078 Capsules in Treating Postpartum Depression
Lead Sponsor:
Nanjing Minova Pharmaceutical Co., Ltd.
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06963580
Start Date
September 9 2024
End Date
December 1 2025
Last Update
August 26 2025
Active Locations (21)
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1
The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital
Wuhu, Anhui, China, 241000
2
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China, 100096
3
Xiamen Xian Yue Hospital
Xiamen, Fujian, China
4
Shunde Hospital of Southern Medical University
Foshan, Guangdong, China, 528308