JPRN-jRCT2080223209已完成3 期
A 12-week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 289
研究概览
简要总结
The effectiveness data suggest that lurasidone treatment improves positive and negative symptoms of schizophrenia and global symptoms. In addition, there were no unexpected AEs or clinically significant changes in any of the safety parameters. Safety results of this study were consistent with the results from the core study (D1001066) and follow the known safety profile of lurasidone and other atypical antipsychotic drugs of the same class.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •Subject has completed the study D1001066 and has completed all required assessments on the final study visit.
- •- Subject who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study etc.
排除标准
- •- Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, or others.
- •- Subject who are otherwise considered ineligible for the study by the investigator etc.
研究者
相似试验
已完成
3 期
Lurasidone - A 24-week Extension Study of Patients With Bipolar I DepressionBipolar DepressionNCT00868959Sumitomo Pharma America, Inc.817
已完成
3 期
A Phase III study of SM-13496 in patients with schizophreniaSchizophreniaJPRN-jRCT2080223187Sunovion Pharmaceuticals Inc.,483
已完成
3 期
Major Depressive Disorder With Mixed Features - ExtensionMajor Depressive DisorderNCT01423253Sumitomo Pharma America, Inc.48
进行中（未招募）
3 期
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With HypertensionHypertensionNCT05968430Mineralys Therapeutics Inc.1,076
已完成
3 期
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)Bipolar DepressionNCT00868452Sumitomo Pharma America, Inc.348