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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
The Affiliated Beijing Anding Hospital of Capital Medical University, Wuhu Hospital
Wuhu, Anhui, China
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.
Time frame: up to day 31
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.
Time frame: up to day 31
HAM-D17 remission
Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression
Time frame: 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
Time frame: 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
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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
...and 11 more locations
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: up to day 31