A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
研究概览
简要总结
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia 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
- 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 the following key inclusion criteria:
- •Completed written informed consent.
- •Aged 18 to 65 years, inclusive, at the time of informed consent.
- •Primary diagnosis of MDD.
- •Participants must meet one of the following criteria:
- •must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening.
- •must have received ≥1 antidepressant medication(s) for ≥8 weeks in the current or most recent episode of depression.
- •Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day
排除标准
- •Participants will be excluded from the study if they meet any of the following key criteria:
- •Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
- •Have a significant risk of suicidal or violent behavior.
- •A history of seizure disorder, stroke, Alzheimer disease, Parkinson disease, multiple sclerosis, head injury associated with loss of consciousness for more than 15 minutes, or other neurodegenerative disorder.
研究组 & 干预措施
Placebo
Participant follows Placebo schedule (57 days)
干预措施: Placebo (Drug)
Antidepressant
Participant follows NBI-1065846 schedule (57 days)
干预措施: NBI-1065846 (Drug)
结局指标
主要结局
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
时间窗: Baseline, Day 57
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
次要结局
- Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression(Baseline, Day 57)
- CGI-S Scores(Baseline and Day 57)