NCT04039022已完成3 期
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
研究概览
简要总结
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
详细描述
A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder, including treatment resistant depression
- •Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- •Agree to use adequate method of contraception for the duration of the study
- •Additional criteria may apply
排除标准
- •Suicide risk
- •Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- •Additional criteria may apply
研究组 & 干预措施
AXS-05
Experimental
干预措施: AXS-05 (dextromethorphan and bupropion) oral tablets (Drug)
结局指标
主要结局
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
时间窗: Up to 12 months
Types and rates of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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