NCT00102518已完成3 期
A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 325 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
- 325
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Experiencing SAEs
研究概览
简要总结
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode
排除标准
- •Patients with a co-morbid serious, uncontrolled systemic illness
- •Patients with a significant risk of committing suicide
研究组 & 干预措施
NCT00102063 and NCT00110461 Subjects
Experimental
All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Percentage of Subjects Experiencing SAEs
时间窗: Baseline and Week 23
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
次要结局
- Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline and Week 26)
- Change in Young Mania Rating Scale (Y-MRS) Total Score(Baseline and Week 26)
研究者
研究点 (1)
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