NCT06911112招募中3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 40
- 主要终点
- Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
研究概览
简要总结
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
- •Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
- •Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
- •Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- •Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
排除标准
- •A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
- •Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- •Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
干预措施: Placebo (Drug)
NBI-1065845
Experimental
NBI-1065845 administered orally once a day.
干预措施: NBI-1065845 (Drug)
结局指标
主要结局
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
时间窗: Baseline, Day 56
次要结局
- Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56(Baseline, Day 56)
- Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56(Baseline, Day 56)
研究者
研究点 (40)
Loading locations...
相似试验
招募中
3 期
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive DisorderNCT06786624Neurocrine Biosciences200
已完成
2 期
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)Major Depressive DisorderNCT05203341Neurocrine Biosciences183
终止
2 期
Study of BIIB092 in Participants With Progressive Supranuclear PalsySupranuclear Palsy, ProgressiveNCT03068468Biogen490
已完成
2 期
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette SyndromeTourette SyndromeNCT02679079Neurocrine Biosciences98
已完成
2 期
Safety and Efficacy Study of NBI-98854 in Adults With Tourette SyndromeTourette SyndromeNCT02581865Neurocrine Biosciences124