ADHD Clinical Trial - Irritability in Children With ADHD & Emotion

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05974241
Study type	Interventional
Source	Tri-Service General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	April 21, 2017
Completion date	April 7, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03148782` - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase	N/A
Recruiting	`NCT06038942` - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress	N/A
Not yet recruiting	`NCT06456372` - Digital Health Intervention for Children With ADHD	N/A
Completed	`NCT05518435` - Managing Young People With ADHD in Primary Care Study
Active, not recruiting	`NCT04978792` - Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?	N/A
Completed	`NCT03216512` - Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD	N/A
Completed	`NCT02900144` - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)	N/A
Completed	`NCT02829528` - Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention	N/A
Not yet recruiting	`NCT02906501` - Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances	N/A
Completed	`NCT02562469` - ACTIVATE: A Computerized Training Program for Children With ADHD	N/A
Terminated	`NCT02271880` - Improving Medication Adherence in ADHD Adolescents	N/A
Recruiting	`NCT02255565` - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Phase 4
Completed	`NCT02463396` - Mindfulness Training in Adults With ADHD	N/A
Terminated	`NCT01733680` - Amiloride Hydrochloride as an Effective Treatment for ADHD	Early Phase 1
Completed	`NCT01673594` - Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist	Phase 4
Completed	`NCT02300597` - Internet-based Support for Young People With ADHD and Autism - a Controlled Study	N/A
Active, not recruiting	`NCT01137318` - Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)	Phase 2
Completed	`NCT01404273` - Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder	N/A
Completed	`NCT00573859` - The Reinforcing Mechanisms of Smoking in Adult ADHD	Phase 1/Phase 2
Completed	`NCT00586157` - Study of Medication Patch to Treat Children Ages 6-12 With ADHD	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Irritability in Children With ADHD and Emotion Dysregulation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms