Irritability in Children With ADHD and Emotion Dysregulation: Clinical Profiles, Neuropsychological Characteristics , and Pharmacological Treatment: A Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Aberrant Behavior Checklist-irritability subscale (ABC-I)
研究概览
简要总结
Objective:
Emotion dysregulation is common among children with ADHD and associated with a broad range of adult psychopathology, which is similar to the longitudinal outcomes of childhood irritability. However, the profiles of irritability in children with ADHD and emotion dysregulation has been understudied. This study aimed to investigate the efficacy of methylphenidate and aripiprazole in the treatment of irritability in children with ADHD and emotion dysregulation. In addition, the clinical profiles and neuropsychological characteristics of irritability in children with ADHD were explored.
详细描述
Methods:
A three-step, open-label, 10 week pilot study was conducted. Methylphenidate (4 weeks), aripiprazole (4 weeks), and the combination (2weeks) were examined in sequence as the treatment for irritability in children with ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile. The primary outcome was improvement of irritability as measured by Aberrant Behavior Checklist-irritability subscale (ABC-I). During the first step, the subjects received pharmacological treatment of methylphenidate with flexible dosage for 4 weeks. Those subjects who had suboptimal response to methylphenidate (reduction of ABC-I score < 25%) entered the second step and the medication was switched to aripiprazole. After 4 weeks of treatment, those whose ABC-I scores reduced < 25% entered the third step and received the treatment of combination of methylphenidate and aripiprazole for two weeks (3rd step).
Clinical profiles of irritability were evaluated with the Affective Reactivity Index (ARI), the Strengths and Difficulties Questionnaire, the Social Adjustment Inventory for Children and Adolescents, and the Autism Behavior Checklist-Taiwan Version. The neurophysiological characteristics of the subjects were assessed by three Cantab subtests: Emotion Recognition Task, One Touch Stockings of Cambridge, and Spatial Working Memory. The aforementioned measurements were administered at baseline and at the end of each step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6 to 18 who have ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile.
排除标准
- •Patients who are not willing to participate in the study after detailed explanation.
- •Patients who have intellectual disability or could not follow the investigator's instructions.
- •Patients who have severe neurological or mental illness like epileptic disorder, schizophrenia, bipolar disorder, or uncontrolled suicide risk.
- •Patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, or severe congenital heart disease.
- •Patients who are allergic to methylphenidate or aripiprazole.
研究组 & 干预措施
Pharmacological treatment
During the first step, the subjects received pharmacological treatment of methylphenidate with flexible dosage for 4 weeks. Those subjects who had suboptimal response to methylphenidate entered the second step with aripiprazole. After 4 weeks of treatment, those had suboptimal response to aripiprazole entered the third step and received the treatment of combination of methylphenidate and aripiprazole for two weeks (3rd step).
干预措施: Methylphenidate, aripiprazole, and combination (Drug)
结局指标
主要结局
Aberrant Behavior Checklist-irritability subscale (ABC-I)
时间窗: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
The ABC is an instrument developed to assess emotional and behavioral difficulties in individuals with developmental disabilities. However, its irritability subscale (ABC-I) is a proven well-validated and widely used rating inventory for measuring irritability in neurotypical children. This subscale consists of 15 items about irritability, aggression, tantrums, agitation, and unstable mood.
次要结局
- Affective Reactivity Index (ARI)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
- Cantab subtest-- Spatial Working Memory (SWM)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
- Cantab subtest-- Emotion Recognition Task (ERT)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
- The Strengths and Difficulties Questionnaire (SDQ)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
- Social Adjustment Inventory for Children and Adolescents (SAICA)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
- Cantab subtest-- One Touch Stockings of Cambridge (OTS)(4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step)
研究者
Chin-Bin Yeh, MD, PhD
Attending Physician
Tri-Service General Hospital