Irritability in Children With ADHD and Emotion Dysregulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2022-04-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Mood ADHD

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

A three-step, open-label, 10 week pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pharmacological treatment

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).

Group Type EXPERIMENTAL

Methylphenidate, aripiprazole, and combination

Intervention Type 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).

Interventions

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Methylphenidate, aripiprazole, and combination

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).

Intervention Type DRUG

Other Intervention Names

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Ritalin/Concerta, Abilify, and combination

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No