A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 4
- 主要终点
- Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)
研究概览
简要总结
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.
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
- Double (Participant, Investigator)
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
- •Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- •Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
- •Subjects experiencing an acute exacerbation of psychotic symptoms
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- •Subjects with a current DSM-IV-TR Axis I diagnosis of:
- •Schizoaffective disorder
- •Bipolar disorder
- •Delirium, dementia, amnestic or other cognitive disorder
- •Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
- •Subjects presenting with a first episode of schizophrenia
- •Other protocol specific inclusion/exclusion criteria may apply
研究组 & 干预措施
1
OPC-34712 0.25 mg arm
干预措施: OPC-34712 (Drug)
2
OPC-34712 low-dose arm
干预措施: OPC-34712 (Drug)
3
OPC-34712 mid-dose arm
干预措施: OPC-34712 (Drug)
4
OPC-34712 high-dose arm
干预措施: OPC-34712 (Drug)
5
干预措施: Placebo (Drug)
6
Aripiprazole arm
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 (Double Blind Phase)
时间窗: Baseline to Week 6
The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is 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 ranges from 30-210, with higher scores indicating more severe symptoms.
次要结局
- Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)(Baseline to Week 6)
- Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712(Baseline to Week 6)
- Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)(Baseline to Week 6)
- Mean Clinical Global Impression - Improvement (CGI-I) at Week 6(Week 6)
- Response Rate at Week 6(Week 6)