A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Aberrant Behavior Checklist
研究概览
简要总结
This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between ages of 12 and 21 years
- •Tanner Sage III or IV (post-pubertal)
- •Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of autism
- •Outpatient
- •Ability to swallow pills
- •Antipsychotic medication-free for at least 2 weeks
- •Score of 4 or more on the Clinical Global Impressions Severity Scale
- •Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale
- •Mental age of 18 months or greater based on testing
- •Subjects must be in good physical health
排除标准
- •Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, Fragile X Syndrome, Tuberous Sclerosis
- •A significant medical condition
- •An active seizure disorder
- •Females who are pregnant
- •Evidence of a prior adequate trial of paliperidone ER
- •History of neuroleptic malignant syndrome
- •Hypersensitivity to paliperidone ER
研究组 & 干预措施
Paliperidone ER
8-Week Open-Label
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
The Aberrant Behavior Checklist
时间窗: Week 8
The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each item is rated from 0 (not at all to 3 (severe). The ABC has 5 subscales:Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe) and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe).
The Clinical Global Impression-Improvement(CGI-I)
时间窗: Week 8
The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.
次要结局
- The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders(Week 8)
- The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain(Week 8)
- The Social Responsiveness Scale(Week 8)