NCT05203341已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)
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
- 183
- 试验地点
- 1
- 主要终点
- Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo 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 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 these criteria for inclusion in the study:
- •The participant has completed written informed consent.
- •At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
- •The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
- •Participant must have had inadequate response to antidepressant treatment.
- •Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
- •Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
- •Participants must be willing and able to comply with all study procedures.
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 plans 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 that was the primary focus of treatment other than MDD.
- •The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
- •The participant has an alcohol or substance use disorder.
- •In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo orally once a day.
干预措施: Placebo (Drug)
NBI-1065845 Low Dose
Experimental
Participants will receive low-dose NBI-1065845 orally once a day.
干预措施: NBI-1065845 (Drug)
NBI-1065845 High Dose
Experimental
Participants will receive high-dose NBI-1065845 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 28
时间窗: Baseline, Day 28
次要结局
- Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56(Baseline, Days 7, 14, and 56)
- Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56(Baseline, Days 28 and 56)
- Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56(Baseline, Days 28 and 56)
- Remission, defined as MADRS ≤10, at Days 28 and 56(Days 28 and 56)
- Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56(Baseline, Days 28 and 56)
研究者
研究点 (1)
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