NCT06830044招募中3 期
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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
- 500
- 试验地点
- 54
- 主要终点
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
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
- •Male or female patient 18 to 65 years of age, inclusive;
- •Meets DSM-5-TR criteria for MDD
- •Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)
排除标准
- •Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
- •Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
- •Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment
研究组 & 干预措施
Milsaperidone
Experimental
干预措施: Milsaperidone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 6 weeks
The MADRS is a clinician-rated 10 item scale. Individual item scores are summed for a total possible score of 0 to 60 with a higher score indicating increased severity of depressive symptoms.
次要结局
未报告次要终点
研究者
研究点 (54)
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