Long-term Study of DSP-5423P in Patients With Schizophrenia <Phase 3>
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse Events and Adverse Drug Reactions, Etc.
研究概览
简要总结
The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria
- •Patients who are aged 18 years or older at informed consent
- •Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.
排除标准
- •Patients who fall under a contraindication listed in the LONASEN® package insert
- •Patients with Parkinson disease, etc.
研究组 & 干预措施
DSP-5423P
Percutaneous
干预措施: DSP-5423P (Drug)
结局指标
主要结局
Adverse Events and Adverse Drug Reactions, Etc.
时间窗: week 52
Number of Subjects With Adverse Event (AE) and Adverse Drug Reaction (ADR) An adverse event (AE) is any untoward medical occurrence in a study subject administered a medicinal (investigational) product and which does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. An adverse drug reaction (ADR) is any AE which has a causal relationship with this treatment.
次要结局
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week52 and Week 52 Last Observation Carried Forward(LOCF) From DSP-5423P Baseline(Week 52, Week 52 (LOCF))