EUCTR2011-002514-37-SK进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- •2.Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
- •3.Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
- •4.Other protocol specific inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- •2.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
- •3.Subjects presenting with a first episode of schizophrenia
- •4.Other protocol specific exclusion criteria may apply.
研究者
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