A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of Ropanicant in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
- 试验地点
- 33
- 主要终点
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
研究概览
简要总结
The primary objective is to evaluate the efficacy of Ropanicant at two different dosage levels compared to placebo in patients with Major Depressive Disorder (MDD).
详细描述
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of Ropanicant versus placebo in patients with MDD. The study will be conducted at multiple centers located in the US.
This study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. Approximately 195 patients will be randomly assigned to receive Ropanicant Dose Level 1 bid or Dose Level 2 bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).
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
- •Patients must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for MDD without psychotic features based on the Mini International Neuropsychiatric Interview (MINI) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months.
- •Patients must have a Clinical Global Impression-Severity (CGI-S) score of ≥
- •Patients must have a Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) score of ≥
- •Patients must have a Snaith-Hamilton Pleasure Scale (SHAPS) score of ≥
- •Patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures.
排除标准
- •Patients who meet criteria for treatment-resistant depression (TRD) during the current major depressive episode, which is defined as being nonresponders (<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration.
- •Patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ECG results, or laboratory assessments.
- •Female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding.
- •Patients with bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG results.
研究组 & 干预措施
Ropanicant Dose Level 1
干预措施: Ropanicant (Drug)
Ropanicant Dose Level 2
干预措施: Ropanicant (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6
时间窗: Baseline to Week 6
The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). The total score is the sum of 10 items and can take range from 0 to 60. A higher score represents a higher severity of the level of depression.
次要结局
- Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Week 6(Baseline to Week 6)