An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 18
- 主要终点
- The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
研究概览
简要总结
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.
The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.
详细描述
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
- •Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.
排除标准
- •Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
研究组 & 干预措施
1
BCI-024 and BCI-049
干预措施: Combination Product: BCI-024 + BCI-049 (Drug)
结局指标
主要结局
The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
时间窗: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)
次要结局
未报告次要终点
研究者
Maurizio Fava, MD
Fava, Maurizio, MD
Massachusetts General Hospital