NCT04432688已完成不适用
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
Sumitomo Pharma (Suzhou) Co., Ltd.7 个研究点 分布在 1 个国家目标入组 3,192 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,192
- 试验地点
- 7
- 主要终点
- The incidence of Adverse Event
研究概览
简要总结
It's a prospective, non-interventional, observational Post-marketing Surveillance..
详细描述
It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of the surveillance is to observe the safety and overall effectiveness of Latuda® in the treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as well as the dose of Latuda® for monotherapy or combination therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia Patients who begin to receive Latuda®
- •Exclusion criteria:
- •No exclusion criteria
排除标准
- 未提供
研究组 & 干预措施
Latuda®
Chinese schizophrenia patients who are receiving Latuda® in the real world
干预措施: Lurasidone HCl (Drug)
结局指标
主要结局
The incidence of Adverse Event
时间窗: week 12
Adverse events
次要结局
- The incidence of extrapyramidal symptom(baseline/ week 2-4/ week 6-8/ week 12)
- The incidence of akathisia(baseline/ week 2-4/ week 6-8/ week 12)
- Changes in body weight at the end of treatment compared with baseline(baseline/ week 12)
- The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline(baseline/ week 2-4/ week 6-8/ week 12)
- the rate of use of extrapyramidal symptom treatment drugs(baseline/ week 2-4/ week 6-8/ week 12)
研究者
研究点 (7)
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