NCT03924492Approved For Marketing不适用
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has signed an informed consent form prior to any study-specific procedures being performed
- •Subject is an ambulatory female at least 18 years of age
- •Subject agrees to adhere to the study requirements
- •Subject agrees not to be the primary caregiver of any dependents during the infusion
- •Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
- •Subject has a current diagnosis of PPD, as assessed by the Investigator
排除标准
- •Subject has end stage renal disease
- •Subject has a known allergy to progesterone or allopregnanolone
研究者
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