Irritability in Children With ADHD and Emotion Dysregulation
Condition: Irritable Mood; ADHD
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Methylphenidate, aripiprazole, and combination
Intervention type(s): Drug
Intervention description(s): Methylphenidate (4 weeks), aripiprazole (4 weeks), and the combination (2weeks). 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).
Other intervention name(s): Ritalin/Concerta, Abilify, and combination
Intervention MeSH terms: Aripiprazole; Methylphenidate
Intervention model: Sequential Assignment
Intervention model description: A three-step, open-label, 10 week pilot study
Masking: None (Open Label)
Primary purpose: Treatment