Clinical trial NCT05974241: Irritability in Children With ADHD and Emotion Dysregulation
Official title: Irritability in Children With ADHD and Emotion Dysregulation: Clinical Profiles, Neuropsychological Characteristics , and Pharmacological Treatment: A Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Mood
ADHD
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: A three-step, open-label, 10 week pilot study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Affective Reactivity Index (ARI)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
measure: Social Adjustment Inventory for Children and Adolescents (SAICA)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
measure: Cantab subtest-- Emotion Recognition Task (ERT)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
measure: Cantab subtest-- One Touch Stockings of Cambridge (OTS)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
measure: Cantab subtest-- Spatial Working Memory (SWM)
timeFrame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Tri-Service General Hospital
name: Chin-Bin Yeh, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: