An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
研究概览
简要总结
The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia
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
Oral Aripiprazole
Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
时间窗: Up to 72 months
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. Additional information about Adverse Events can be found in the Adverse Event section.
次要结局
- Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, Up to 72 months)
- Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score(Baseline, Last Visit (Up to 72 Months))
- Number of Participants With Clinical Significant Laboratory Tests(Baseline, Up to 72 Months)
- Number of Participants With Clinically Significant Heart Rate(Baseline, Up to 72 months)
- Number of Participants With Clinically Significant Blood Pressure(Baseline, Up to 72 months)
- Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations(Baseline, Up to 72 months)
- Number of Participants Showing Significant Weight Gain or Loss(Baseline, Up to 72 months)