NCT01034267已完成3 期
A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder
Forest Laboratories68 个研究点 分布在 1 个国家目标入组 828 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 828
- 试验地点
- 68
- 主要终点
- Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
研究概览
简要总结
The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
- •Have normal examination findings at the final visit of the lead-in study
- •Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential
排除标准
- •Any exclusionary psychiatric or medical condition that developed during the lead in study
- •Patients considered a suicide risk
- •Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception
研究组 & 干预措施
1
Experimental
(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing
干预措施: F2695 SR (Drug)
结局指标
主要结局
Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
研究点 (68)
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