Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
研究概览
简要总结
The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receiving aripiprazole at time of screening
- •Men and women ages 18 to 70
排除标准
- •All patients previously discontinued from an aripiprazole study for any reason
- •Active alcohol or substance abuse
- •Patients who represent a significant risk of committing suicide
- •Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings
研究组 & 干预措施
AI
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.
时间窗: Baseline to Week 348
Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.
次要结局
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population(Baseline to Week 348)
- Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population(Day 1 to Day 1170)
- Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population(Baseline to end of study (Week 348))
- Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population(Baseline to end of study (Week 348)