JPRN-jRCT2080221592已完成3 期
A long-term trial of OPC-34712 in patients with schizophrenia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
研究概览
简要总结
ong-term administration of brexpiprazole had a sustained therapeutic effect, did not show any major results of safety concern, and was well tolerated. Long-term administration was possible in subjects aged 65 years or older, similar to subjects aged younger than 65 years. It was possible for patients to switch from therapy with prior antipsychotics to monotherapy with brexpiprazole within 4 weeks without any problems, and the condition remained stable even after switching.
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 age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
- •- Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible
排除标准
- •- Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
- •- Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis I criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
研究者
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