A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Change from baseline in HAM-D17 total score compared to placebo
研究概览
简要总结
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
- If LPCN 1154A reduces depressive symptoms in subjects with severe PPD
- How well LPCN 1154A is tolerated and what side effects it may cause
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are female between 15 and 45 years of age, inclusive;
- •Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
- •Are < 18 months postpartum at Screening
- •Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
排除标准
- •Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
- •Are currently experiencing active psychosis per Investigator assessment
- •Have a history of suicidal behavior associated with the current depressive episode
- •Have a history of seizure within six months of Screening
研究组 & 干预措施
LPCN 1154A Tablets
LPCN 1154A Tablets
干预措施: LPCN 1154A (Drug)
Placebo Tablets
Placebo Tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in HAM-D17 total score compared to placebo
时间窗: Baseline to Hour 60
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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
次要结局
- Change from baseline in HAM-D17 total score(Baseline to Hour 12 and Day 30)
- Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response(Baseline to Hour 12, Hour 60 and Day 30)