Irritability in Children With ADHD and Emotion Dysregulation

NCT05974241 | Completed Phase 4

• 1 other identifier: TSGH-C106-103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Mood; ADHD

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist-irritability subscale (ABC-I)

  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.

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

Secondary Outcomes (6)

• Affective Reactivity Index (ARI)

  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

• 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

• 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

• 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

Study Arms (1)

Pharmacological treatment

EXPERIMENTAL

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).

Drug: Methylphenidate, aripiprazole, and combination

Interventions

Methylphenidate, aripiprazole, and combination DRUG

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).

Also known as: Ritalin/Concerta, Abilify, and combination

Pharmacological treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 6 to 18 who have ADHD and emotion dysregulation, defined by the CBCL-Dysregulation Profile.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

Location

Related Publications (1)

• Pan PY, Yeh CB. The Role of Methylphenidate and Aripiprazole in the Treatment of Emotion Dysregulation in Children With ADHD. J Clin Psychopharmacol. 2025 Jul-Aug 01;45(4):356-363. doi: 10.1097/JCP.0000000000002002. Epub 2025 Apr 16.

  PMID: 40238929 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Aripiprazole

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chin-Bin Yeh, MD., PhD.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: A three-step, open-label, 10 week pilot study

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: April 21, 2017
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

TW (1)