JPRN-jRCT2080222713已完成3 期
ong-term Study of DSP-5423P in Patients with Schizophrenia <Phase 3>
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
ong-term application of DSP-5423P: No safety concerns were noted and the long-term effectiveness was demonstrated. Switching from DSP-5423 (tablet) administration to DSP-5423P application: No safety concerns were noted caused by the switching. No impact on the effectiveness by the switching The plasma concentration of bronanserin was higher with a higher daily dose immediately before blood sampling, and it was almost stable per daily dose immediately before blood sampling throughout the treatment period.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
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.
研究者
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