NCT04634669终止2 期
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 181
- 试验地点
- 20
- 主要终点
- Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
研究概览
简要总结
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures
详细描述
Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features and with prior antidepressant treatment failure
- •Agree to use adequate method of contraception for the duration of the study
- •Additional criteria may apply
排除标准
- 未提供
研究组 & 干预措施
AXS-05 (dextromethorphan-bupropion)
Experimental
干预措施: AXS-05 (dextromethorphan-bupropion) (Drug)
结局指标
主要结局
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
时间窗: Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date.
次要结局
未报告次要终点
研究者
研究点 (20)
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