A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 568
- 试验地点
- 51
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18-75 years old
- •Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- •The patient's current depressive episode must be at least 6 weeks in duration
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- •Patients who are considered a suicide risk
- •Patients with a history of meeting DSM-IV-TR criteria for
- •a. any manic or hypomanic episode
- •b. schizophrenia or any other psychotic disorder
- •c. obsessive-compulsive disorder.
研究组 & 干预措施
1
40mg Levomilnacipran ER
干预措施: Levomilnacipran ER (Drug)
2
80mg of Levomilnacipran ER
干预措施: Levomilnacipran ER (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
时间窗: From Baseline to Week 8
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).
次要结局
- Change in Sheehan Disability Scale (SDS) Total Score(From Baseline to Week 8)