An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 230
- 试验地点
- 73
- 主要终点
- Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of lead-in study
- •Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator
排除标准
- •Suicide risk, as determined by meeting any of the following criteria:
- •A suicide attempt within the past year
- •Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
- •Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
- •At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
- •Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
- •Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception
研究组 & 干预措施
Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
干预措施: Rapastinel (Drug)
结局指标
主要结局
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 45 Weeks
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
次要结局
未报告次要终点