A Placebo-controlled Study of MD-120 in Patients With Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period
研究概览
简要总结
The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
- •Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.
排除标准
- •Patient who meets DSM-5 criteria of the following disorders for current or past history.
- •Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)
- •Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.
研究组 & 干预措施
MD-120 100 mg
干预措施: Desvenlafaxine 100 mg (Drug)
MD-120 50 mg
干预措施: Desvenlafaxine 50 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Total MADRS Score From the Baseline to Week 8 Visit During the Treatment Period
时间窗: 8 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score: Scale ranges from 0 to 60 with a higher score indicating worsening symptoms of depression. Estimates were based on a Mixed-effects Model for Repeated Measures (MMRM) model with the treatment group, assessment timepoint, and the interaction between the treatment group and assessment timepoint as a factor and total MADRS score at baseline as a covariate.
Number of Participants With Adverse Events (AEs)
时间窗: 10 weeks
An adverse event is any undesirable or unintended sign (including abnormal findings in general laboratory tests, body weight, and standard 12-lead ECG), symptom, or disease in a subject given the investigational drug, irrespective of the causal relationship to the investigational drug.
次要结局
- Plasma Concentration of Desvenlafaxine(Week 2 through week 8)
- Changes in Total HAM-D17 Score From the Baseline to Week 8 Visit During the Treatment Period(8 weeks)
- Number of Participants With Adverse Drug Reactions (ADRs)(10 weeks)