An Open-Label Pilot Study of Esomeprazole in Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
研究概览
简要总结
Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients 2 to 6 years of age;
- •males and females who are physically healthy;
- •diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)
- •care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;
- •ability of subject to swallow the compound;
- •stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);
- •no planned changes in psychosocial interventions during the open-label trial.
排除标准
- •DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;
- •prior adequate trial of Esomeprazole;
- •active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).
研究组 & 干预措施
Esomeprazole
Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Change from Baseline on the Social Responsiveness Scale, 2nd Edition (SRS-2)
时间窗: Baseline, 4 Weeks, 8 Weeks
Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
次要结局
- Change from Baseline on the Aberrant Behavior Checklist, 2nd Edition (ABC-2)(Baseline, 4 Weeks, 8 Weeks)
研究者
Antonio Hardan
Principal Investigator
Stanford University