A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With 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
- 734
- 试验地点
- 35
- 主要终点
- Time to Relapse (Days)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
详细描述
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.
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 4 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
2
40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
干预措施: Levomilnacipran ER (Drug)
1
Matching placebo capsules, oral administration, once daily dosing.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Relapse (Days)
时间窗: 24 Weeks
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
次要结局
未报告次要终点