Status:

COMPLETED

Irritability in Children With ADHD and Emotion Dysregulation

Lead Sponsor:

Tri-Service General Hospital

Conditions:

Irritable Mood

ADHD

Eligibility:

All Genders

6-18 years

Phase:

PHASE4

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...

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 ir...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

April 21 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 7 2022

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT05974241

Start Date

April 21 2017

End Date

April 7 2022

Last Update

August 7 2023

Active Locations (1)

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1

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan, 114