NCT00095745已完成3 期
A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 1,002 人开始时间: 2004年9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
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Safety assessments
研究概览
简要总结
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 years or older
- •Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
- •Treatment history of an inadequate response to at least one and no more than four antidepressants
排除标准
- 未提供
研究组 & 干预措施
Antidepressant + Aripiprazole
No Intervention
干预措施: Antidepressant + Aripiprazole (Drug)
结局指标
主要结局
Safety assessments
时间窗: throughout the study
次要结局
未报告次要终点
研究者
研究点 (1)
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