NCT02054702已完成3 期
Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute 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
- None
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
- •18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
- •Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
- •Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
- •Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
- •Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
- •Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)
排除标准
- •Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
- •Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
- •Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
- •Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.
研究组 & 干预措施
Brexpiprazole
Experimental
Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally
干预措施: Brexpiprazole (Drug)
Aripiprazole
Experimental
Aripiprazole - Up to 20 mg/day, once daily dose, tablets, orally
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline to Week 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
- Change From Baseline in Cognitive Test Battery Scores of Identification Task(Baseline to Week 6)
- Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6(Baseline to Week 6)
- Change From Baseline in Cognitive Test Battery Scores of Detection Task(Baseline to Week 6)
- Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task(Baseline to Week 6)
- Change From Baseline in Cognitive Test Battery Composite Score(Baseline to Week 6)
- Change From Baseline in Cognitive Test Battery of Early Phase Battery Score(Baseline to Week 6)
- Response Rate by Study Week(Baseline to Week 6)
- Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)(Baseline to Week 6)
- Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score(Baseline to Week 6)
- Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score(Baseline to Week 6)
- Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score(Baseline to Week 6)
研究者
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