Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
研究概览
简要总结
This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.
The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.
详细描述
The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 and 11 years
- •Autism Spectrum Disorder
- •Attention Deficit Hyperactivity Disorder
- •Stimulant medication-free at study entry
- •No clinically significant abnormalities that preclude safe participation
- •Sufficient developmental level (~3 yrs)
- •Able to keep appointments
- •Able to communicate effectively
- •Teacher cooperation
排除标准
- •Received an investigational medication in the previous 30 days
- •Current medication treatment is effective and well-tolerated
- •Medical conditions that affect patient safety
- •MAOIs within one month
- •Hypertension
- •Bipolar disorder or psychosis
- •Anticonvulsants
- •Psychotropic medication or health food supplement
- •Tourette Disorder
- •Seizure disorder
- •Neurological condition
- •Structural heart disease
研究组 & 干预措施
Methylphenidate Transdermal System
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
干预措施: Methylphenidate Transdermal System (Drug)
结局指标
主要结局
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
时间窗: Baseline, 8 weeks
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
次要结局
- Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)
- Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit(Baseline, 8 weeks)