EUCTR2005-005343-26-FI进行中（未招募）不适用
Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to </= 17 Years of Age) with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder - Pediatric Subjects with Schizophrenia, Schizoaffective or Schizophreniform Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
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
- •Subjects may be male or female and must be between 10 and 17 years of age, inclusive (subjects may become 18 during the study but must be 17 years of age on Day 1).
- •Subjects height and weight must be within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex
- •Subjects must have a diagnosis of schizophrenia of any subtype (295.10; 295.20; 295.30; 295.60; 295.90), schizoaffective disorder (295.70), or schizophreniform disorder (295.40), according to the DSM-IV-TR.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with an active DSM-IV-TR axis I diagnosis other than schizophrenia, schizoaffective disorder, or schizophreniform disorder
- •Subjects with a history of DSM-IV-TR diagnosis of substance dependence within 6 months before screening (nicotine and caffeine dependence are not exclusionary)
- •Subjects who are involuntarily committed to psychiatric hospitalization
研究者
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