CompletedPhase 4

Irritability in Children With ADHD and Emotion Dysregulation

Taiwan36 participantsStarted 2017-04-21

Plain-language 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.

Who can participate

Age range6 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 6 to 18 who have ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile. Exclusion Criteria: * 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.

What they're measuring

Aberrant Behavior Checklist-irritability subscale (ABC-I)

Timeframe: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step

Trial details

NCT IDNCT05974241

SponsorTri-Service General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-07

View on ClinicalTrials.gov More Irritable Mood trials