A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 459
- 主要终点
- Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
研究组 & 干预措施
High dose
干预措施: OPC-34712 (Drug)
Mid dose
干预措施: OPC-34712 (Drug)
Low dose
干预措施: OPC-34712 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline, Weeks 1, 2, 3, 4, 5, and 6
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
次要结局
- Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)