JPRN-jRCT2080223187已完成3 期
A 6-week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lurasidone (SM-13496) in Acutely Psychotic Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 483
研究概览
简要总结
Subjects treated with lurasidone 40 mg/day experienced clinically meaningful and statistically significant improvements in the primary and secondary efficacy endpoints. Efficacy results in the overall population were consistent with those observed in Japanese subjects. Overall, and in Japanese subjects, lurasidone 40 mg was generally safe and well tolerated. Safety findings in this study were consistent with the well-known and established safety profile of lurasidone in adult subjects with schizophrenia.
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
- •Patients meets DSM-IV TR criteria for schizophrenia.
- •-Patients understands 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
- •-Patients has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- •-Patient has Parkinson's disease.
- •-Patient has a history or complication of malignancy etc.
研究者
相似试验
已完成
3 期
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)Bipolar DepressionNCT00868452Sumitomo Pharma America, Inc.348
已完成
3 期
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)Bipolar DepressionNCT00868699Sumitomo Pharma America, Inc.505
已完成
3 期
Lurasidone Low-Dose - High-Dose Study StudySchizophreniaNCT01821378Sumitomo Pharma America, Inc.412
已完成
2 期
A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of SchizophreniaSchizophreniaNCT00088634Sumitomo Pharma America, Inc.180
已完成
3 期
A 12-week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with SchizophreniaSchizophreniaJPRN-jRCT2080223209Sunovion Pharmaceuticals Inc.,289