A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,044
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with 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
- Na
- 干预模型
- Single Group
- 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
- •Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- •Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
- •Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
- •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
OPC-34712
干预措施: OPC-34712 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: From Baseline up to 52 Weeks
A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.
次要结局
- Mean Change From Baseline in PANSS Negative Subscale Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score(From Baseline up to 52 Weeks)
- Mean Clinical Global Impression - Improvement Score(From Baseline up to 52 Weeks)
- Discontinuation Rate for Lack of Efficacy(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Positive Subscale Score(From Baseline up to 52 Weeks)
- Response Rate(From Baseline up to 52 Weeks)
- Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in Personal and Social Performance Scale Total Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score(From Baseline up to 52 Weeks)
- Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score(From Baseline up to 52 Weeks)