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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 30
- 主要终点
- Change from baseline in HAM-D17 total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MI078 capsule dose 1
MI078 capsule dose 1
干预措施: MI078 capsule dose 1 (Drug)
MI078 capsule dose 2
MI078 capsule dose 2
干预措施: MI078 capsule dose 2 (Drug)
placebo
Placebo of MI078 capsules
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in HAM-D17 total score
时间窗: up to day 31
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.
次要结局
- Clinical Global Impression - Improvement (CGI-I) scale positive response(up to day 31)
- HAM-D17 response(up to day 31)
- HAM-D17 remission(up to day 31)
- Change from baseline in the CGI-S score(up to day 31)
- Change from baseline in MADRS total score(up to day 31)
- Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score(up to day 31)
- Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score(up to day 31)
- Safety Evaluation Indicators(up to day 31)