NCT00095758已完成3 期
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.28 个研究点 分布在 1 个国家目标入组 1,151 人开始时间: 2004年9月1日最近更新:
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
- 1,151
- 试验地点
- 28
- 主要终点
- Change in a depression rating scale at endpoint
研究概览
简要总结
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients 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
- 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
- •Experienced a 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 antidepressants.
排除标准
- 未提供
研究组 & 干预措施
A1
Placebo Comparator
干预措施: Antidepressant + Placebo (Drug)
A2
Active Comparator
干预措施: Antidepressant + Aripiprazole (Drug)
结局指标
主要结局
Change in a depression rating scale at endpoint
Change in a depression rating scale at endpoint
时间窗: Baseline, Week 8
次要结局
- Change in a disability scale and Clinical Global Impression scale at endpoint
- Change in a disability scale and Clinical Global Impression scale at endpoint(Baseline, Week 8)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
3 期
A Study of Aripiprazole in Patients With Major Depressive DisorderMajor Depressive DisorderNCT00105196Otsuka Pharmaceutical Development & Commercialization, Inc.349
已完成
4 期
Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory SchizophreniaSchizophreniaNCT00328367Seoul National University Hospital61
已完成
3 期
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I DisorderBipolar Disorder ManiaNCT00665366Otsuka Pharmaceutical Development & Commercialization, Inc.493
Unknown
2 期
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine DependenceCocaine DependenceSchizophreniaNCT00737256Paul Saenger44
已完成
3 期
Study of Aripiprazole in Patients With Acute Bipolar ManiaBipolar DisorderNCT00097266Otsuka Pharmaceutical Development & Commercialization, Inc.615