Confirmatory Study of DSP-5423P in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 7
- 主要终点
- Change in PANSS Total Score From Baseline at Week 6
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 blonanserin (LONASEN) package insert
- •Patients with Parkinson disease
- •Patients who previously received blonanserin, etc.
研究组 & 干预措施
DSP-5423P Placebo
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
干预措施: DSP-5423P Placebo (Drug)
DSP-5423P 40mg
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
干预措施: DSP-5423P 40mg (Drug)
DSP-5423P 80mg
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
干预措施: DSP-5423P 80mg (Drug)
DSP-5423P Placebo-to-Flex
Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
干预措施: DSP-5423P Placebo-to-Flex (Drug)
DSP-5423P Active-to-Flex
Percutaneous Subjects received DSP-5423P 40mg or 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
干预措施: DSP-5423P Active-to-Flex (Drug)
结局指标
主要结局
Change in PANSS Total Score From Baseline at Week 6
时间窗: Week 6
The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
次要结局
- Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6(Week 6 (LOCF))
- Treatment Continuation Rate at 28 Weeks and 52 Weeks(Open-Week 28 and Open-Week 52 in the open-label treatment phase)