Irritability in Children With ADHD and Emotion Dysregulation

PHASE4CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 21, 2017

Primary Completion Date

April 7, 2022

Study Completion Date

April 7, 2022

Conditions
Irritable MoodADHD
Interventions
DRUG

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).

Trial Locations (1)

114

Tri-Service General Hospital, National Defense Medical Center, Taipei

All Listed Sponsors
lead

Tri-Service General Hospital

OTHER

NCT05974241 - Irritability in Children With ADHD and Emotion Dysregulation | Biotech Hunter | Biotech Hunter