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Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational,
Hyo-Won Kim1, Eun-Jin Park2, Ji-Hoon Kim3
11 Department of Psychiatry, University of Ulsan College of Medicine , Asan Medical Center, Seoul, South Korea .
Insights
Aripiprazole effectively reduced irritability in Asian children and adolescents with autistic disorder over 12 weeks. The medication was generally well-tolerated, with weight gain being the most common side effect.
Area of Science:
- Child and Adolescent Psychiatry
- Neurodevelopmental Disorders
- Pharmacology
Background:
- Autistic disorder is a neurodevelopmental condition often accompanied by irritability.
- Managing irritability in children and adolescents with autistic disorder is crucial for improving quality of life.
- Aripiprazole is an atypical antipsychotic used to treat various behavioral symptoms.
Purpose of the Study:
- To evaluate the efficacy and tolerability of aripiprazole for treating irritability in Asian children and adolescents with autistic disorder.
- To assess the impact of aripiprazole on specific behavioral subscales in this population.
Main Methods:
- A 12-week, multinational, multicenter, open-label study.
- Sixty-seven Asian children and adolescents (6-17 years) with autistic disorder participated.
- Flexible dosing of aripiprazole was administered, with a mean dose of 5.1 mg/day.
Main Results:
- Aripiprazole significantly decreased caregiver-rated scores on Aberrant Behavior Checklist subscales (Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, Inappropriate Speech) (p < 0.001).
- Clinician-rated Clinical Global Impression Severity of Illness scores also showed significant improvement (p < 0.001).
- The most frequent adverse event was weight gain; no serious drug-related adverse events were reported.
Conclusions:
- Aripiprazole demonstrates effectiveness and good tolerability for managing irritability in Asian pediatric patients with autistic disorder.
- Further research with larger cohorts and extended treatment periods is warranted.
- Findings support aripiprazole as a potential therapeutic option for this specific patient group.
Objectives:
We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study.
Methods:
Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole for 12 weeks (mean dose, 5.1 ± 2.5 mg; range 2-15 mg).
Results:
Aripiprazole significantly reduced the mean caregiver-rated scores for the Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate Speech subscales of the Aberrant Behavior Checklist from baseline to week 12 (p < 0.001 for all subscales). Clinician-rated Clinical Global Impression Severity of Illness scale score also improved from baseline through week 12 (p < 0.001). The most common adverse event was weight gain and no serious adverse event related to aripiprazole treatment was noted.
Conclusion:
Our results suggest that aripiprazole is effective and generally tolerable in the treatment of irritability in Asian children and adolescents with autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.
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