NCT06267846已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 14
- 主要终点
- Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
研究概览
简要总结
To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Participants must meet all of the following inclusion criteria:
- •Primary diagnosis of recurrent MDD or persistent MDD.
- •Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
- •Participants must be willing and able to comply with all study procedures and restrictions.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Participant is pregnant or breastfeeding or plan to become pregnant during the study.
- •Participant has an unstable medical condition or unstable chronic disease.
- •Participant has a history of neurological abnormalities.
- •Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
- •Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
- •Participant has an alcohol or substance use disorder.
- •Note: Other inclusion/exclusion criteria may apply
研究组 & 干预措施
NBI-1070770: Low Dose
Experimental
Participants will receive low-dose NBI-1070770.
干预措施: NBI-1070770 (Drug)
NBI-1070770: Medium Dose
Experimental
Participants will receive medium-dose NBI-1070770.
干预措施: NBI-1070770 (Drug)
NBI-1070770: High Dose
Experimental
Participants will receive high-dose NBI-1070770.
干预措施: NBI-1070770 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
时间窗: Baseline, Day 5
次要结局
- Change in Total MADRS Score from Baseline at Postbaseline Timepoints(Baseline, up to Day 49)
研究者
研究点 (14)
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