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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI078 capsule dose 1 | Experimental | MI078 capsule dose 1 |
|
| MI078 capsule dose 2 | Experimental | MI078 capsule dose 2 |
|
| placebo | Placebo Comparator | Placebo of MI078 capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI078 capsule dose 1 | Drug | MI078 capsule dose 1 for 3 days |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| huafang Li | Shanghai Mental Health Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital | Wuhu | Anhui | 241000 | China | ||
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| MI078 capsule dose 2 |
| Drug |
MI078 capsule dose 2 for 3 days |
|
| placebo | Drug | placebo for 3 days |
|
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 |
| Beijing HuiLongGuan Hospital |
| Beijing |
| Beijing Municipality |
| 100096 |
| China |
| Xiamen Xian Yue Hospital | Xiamen | Fujian | China |
| Shunde Hospital of Southern Medical University | Foshan | Guangdong | 528308 | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
| Guangxi Zhuang Autonomous Region People's Hospital | Nanning | Guangxi | 530021 | China |
| The People's Hospital of Guizhou Province | Guiyang | Guizhou | 550002 | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050023 | China |
| Xingtai People's Hospital | Xingtai | Hebei | 054001 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200122 | China |
| Shanghai Pudong New Area Mental Health Center | Shanghai | Shanghai Municipality | 200124 | China |
| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
| The First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| The First People's Hospital of Hangzhou | Hangzhou | Zhejiang | 310006 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| The Affiliated Kangning Hospital of Ningbo University | Ningbo | Zhejiang | 315201 | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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