A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 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
- 724
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients 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
- Triple (Participant, 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
- •Men and women, 18-65 years old
- •Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- •The patient's current depressive episode must be at least 8 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 with a history of meeting DSM-IV-TR criteria for:
- •any manic or hypomanic episode
- •schizophrenia or any other psychotic disorder
- •obsessive-compulsive disorder
- •Patients who are considered a suicide risk
研究组 & 干预措施
1
40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.
干预措施: Levomilnacipran ER (Drug)
2
80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
干预措施: Levomilnacipran ER (Drug)
3
120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
干预措施: Levomilnacipran ER (Drug)
4
Matching placebo capsules, oral administration, once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: From Baseline to Week 8
The MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms).
次要结局
- Change in Sheehan Disability Scale (SDS) Total Score(From Baseline to Week 8)