Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)
研究概览
简要总结
To evaluate the efficacy of multiple-dose oxytocin treatment on core autism symptoms using standardized assessments in children with ASD and comorbid ID. Change from baseline after oxytocin administration on: -Behavioral measurements of core autism (social) symptoms -Cardio electrophysiological measurements of stress
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children within an age-range of 4 to 13 years old with a clinical multidisciplinary diagnosis of ASD; only premenstrual girls will be included (girls with onset of menstruation during the course of the trial are allowed to continue the treatment).
- •Children must be enrolled in a special need school, more specific a class comprising children with an intellectual disability or meet intellectual disability criteria; a total IQ below 75 and an ABAS score below 70
排除标准
- •Patient activelytakes anti-epileptic medication or has an active medical problem like cardiac pathology or serious liver, renal problems which influence the metabolism of oxytocin (IMP)
- •Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)
- •Significant hearing or vision impairments
- •Subjects who have had previous chronic treatment with oxytocin
- •Participation in another clinical trial with IMP
- •Known hypersensitivity to active substance or ingredients of the nasal spray
结局指标
主要结局
The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)
The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)
The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated)
The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated)
Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest
Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest
次要结局
- The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated)
- The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated)
- The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated)
- The Perceived Stress Scale (PSS) (parent (caregiver)-rated)
- The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)
研究者
Kaat Alaerts
Scientific
UZ Leuven