JPRN-jRCT2080221591已完成2 期
A dose-finding trial of OPC-34712 in patients with schizophrenia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 447
研究概览
简要总结
Brexpiprazole exerted a therapeutic effect on patients in the acute phase of schizophrenia. While vomiting, blood prolactin increased, diarrhoea, nausea, and dental caries occurred in the brexpiprazole groups at an incidence of 5% or higher and at more than double the incidence in the placebo group, all cases were non-serious and had no effect on the continuation of IMP administration. There were no clinically meaningful marked changes in laboratory values, vital signs, body weight, or ECG.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
- •- Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
- •- Patients who are experiencing acute exacerbation of psychotic symptoms
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 presenting a first episode of schizophrenia based on the clinical judgment of the investigator
- •- 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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