A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 674
- 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
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
详细描述
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.
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
- •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
- •Other protocol specific inclusion criteria may apply
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 exclusion criteria may apply
研究组 & 干预措施
Dose 3 OPC 34712
Higher dose, tablet, once daily, for six weeks
干预措施: OPC-34712 (Drug)
Dose 2 OPC 34712
Middle dose, tablet, once daily, for six weeks
干预措施: OPC-34712 (Drug)
Dose 1 OPC 34712
Lower dose, tablet, once daily, for six weeks
干预措施: OPC-34712 (Drug)
Placebo
Placebo, once daily, for six weeks
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 Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.(Week 6)
- Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.(Baseline, Week 3 and Week 6)
- 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 PANSS Negative Subscale Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Percentage of Participants With Response at Week 6.(Week 6)
- Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.(Week 6)
- Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)
- Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.(Baseline, Weeks 1, 2, 3, 4, 5, and 6)