NCT01456897已完成3 期
A Long-term Trial of OPC-34712 in Patients With 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
- 282
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
- •Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible
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 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
OPC-34712
Experimental
干预措施: OPC-34712 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
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.
次要结局
- Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
- Mean Change From Baseline in PANSS Positive Subscale Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
- Mean Change From Baseline in PANSS Negative Subscale Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
- Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S)(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
- Mean Clinical Global Impression - Global Improvement(CGI-I)(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
研究者
相似试验
已完成
2 期
A Dose-finding Trial of OPC-34712 in Patients With SchizophreniaSchizophreniaNCT01451164Otsuka Pharmaceutical Co., Ltd.459
已完成
3 期
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)DepressionDepressive DisorderDepressive Disorder, MajorMood DisordersMental DisordersNCT01360866Otsuka Pharmaceutical Development & Commercialization, Inc.2,944
已完成
3 期
A long-term trial of OPC-34712 in patients with schizophreniaSchizophreniaJPRN-jRCT2080221592Otsuka Pharmaceutical Co., Ltd.306
已完成
3 期
A Study of OPC-262 in Patients With Type 2 DiabetesType 2 DiabetesNCT01046318Kyowa Kirin Co., Ltd.100
已完成
3 期
Along-term Study of OPC-262 in Patients With Type 2 DiabetesDiabetes, Type 2NCT01634282Kyowa Kirin Co., Ltd.222