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Irritable MoodPhase 4NCT05974241

Irritability in Children With ADHD and Emotion Dysregulation

A Phase 4 study testing Methylphenidate, aripiprazole, and combination in people with Irritable Mood and ADHD, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Irritable Mood, ADHD
What is being tested?
Methylphenidate, aripiprazole, and combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTaiwan
Study dates
21 Apr 2017to 7 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital, National Defense Medical Center

    Taipei, 114

Other trials in Taiwan

About this study

Official title: Irritability in Children With ADHD and Emotion Dysregulation: Clinical Profiles, Neuropsychological Characteristics , and Pharmacological Treatment: A Cross-over Study

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.

Read the 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.

Conditions
Irritable Mood, ADHD
Being tested
Methylphenidate, aripiprazole, and combination
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylphenidate, aripiprazole, and combinationDrug

    Also called Ritalin/Concerta, Abilify, 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).

Study groups in NCT05974241
Study groupRoleWhat they receive
Pharmacological treatmentExperimentalDuring 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).
Receives: Drug: Methylphenidate, aripiprazole, and combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Affective Reactivity Index (ARI)

    The ARI was created as a dimensional measurement of irritability with both parent-report and self-report form. This questionnaire, assessing for symptoms of irritability in the previous 6 months, is composed of 6 items, and the 7th item on functional impairment is rated on a three-point scale (ranging from 0 for "not true" to 2 for "certainly true"). The reliability and validity of the ARI in typically developed children has been previously reported. The sum of scores of the first six items was used in this present study.

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

  2. Social Adjustment Inventory for Children and Adolescents (SAICA)

    The SAICA was designed for children and adolescents aged 6-18 years, and provided a systematic evaluation of children's and adolescents' adaptive functioning. It assessed social adjustment in four major role areas: school, spare-time activities, peer relations, and home life. The scoring of each item ranges from 1 for positive/not a problem, to 4 for negative/severe problem. The children or adolescents with higher scores had either poorer functioning or more severe problems in the assessed domain.

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

  3. The Strengths and Difficulties Questionnaire (SDQ)

    The SDQ is a questionnaire for assessing the psychological problems and strengths in children, consisting of 25 items categorized as 5 subscales based on factor analyses: emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. An impact supplement added to the SDQ provides additional information on the target child's possible difficulties and the burden for others. Previous studies report that the Chinese version of the SDQ is a reliable and valid instrument for clinical studies in Taiwan.

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

  4. Cantab subtest-- Emotion Recognition Task (ERT)

    The outcome measures for ERT cover percentage and number correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once.

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

  5. Cantab subtest-- One Touch Stockings of Cambridge (OTS)

    Outcome measures include the number of problems solved on first choice, mean choices to correct, mean latency (speed of response) to first choice and mean latency to correct. Each of these measures may be calculated for all problems, or for problems with a specified number of moves (one-move to five or six moves).

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

  6. Cantab subtest-- Spatial Working Memory (SWM)

    Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token) and strategy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start21 Apr 2017
  3. Primary completion7 Apr 2022
  4. Study completion7 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A three-step, open-label, 10 week pilot study
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974241
Sponsor's protocol ID
TSGH-C106-103
Status last verified
Aug 2023
First submitted
26 Jul 2023
Last updated
7 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40238929

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylphenidate, aripiprazole, and combination in people with Irritable Mood and ADHD, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aberrant Behavior Checklist-irritability subscale (ABC-I) (time frame: 4 weeks for the 1st step, 4 weeks for the 2nd step, and 2 weeks for the 3rd step). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974241, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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