A Study of Aripiprazole in Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 32
- 主要终点
- Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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 who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
- •Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.
排除标准
- 未提供
研究组 & 干预措施
A1
干预措施: Aripiprazole+ ADT (Drug)
A2
干预措施: Placebo+ ADT (Drug)
结局指标
主要结局
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline (Week 8) and Week 14
Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
次要结局
- Mean Change in SDS Item Score (Social Life)(Baseline (Week 8) and Week 14)
- Mean Change in Sheehan Disability Scale (SDS) Mean Score(Baseline (Week 8) and Week 14)
- Mean Change in SDS Item Score (Work/School)(Baseline (Week 8) and Week 14)
- Mean Change in SDS Item Score (Family Life)(Baseline (Week 8) and Week 14)