Korea Post-Marketing Surveillance of Invega Sustenna
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,267
- 主要终点
- Number of participants with adverse events up to Week 9
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in Korea.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. Safety and efficacy of paliperidone palmitate will be observed in Korean schizophrenic participants for 25 weeks. Approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. Safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with schizophrenia
- •Participants prescribed with paliperidone palmitate for acute or maintenance treatment
排除标准
- •Participants who received paliperidone palmitate for other than the approved indication
研究组 & 干预措施
Paliperidone palmitate
干预措施: No intervention (Drug)
结局指标
主要结局
Number of participants with adverse events up to Week 9
时间窗: Up to Week 9
次要结局
- Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores(Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25)
- Number of participants with adverse events up to Week 25(Up to Week 25)
- Change from baseline in Personal and Social Performance (PSP) scale scores(Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25)