From the Guidelines
Aripiprazole (Abilify) is a recommended treatment for irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents aged 6-17 years, with a fixed dose of 5,10, or 15 mg/d. The use of Aripiprazole in ASD is supported by a study published in the Journal of the American Academy of Child and Adolescent Psychiatry 1, which highlights its efficacy in reducing irritability, hyperactivity, stereotypy, social withdrawal, and inappropriate speech. The study involved 218 children with ASD, aged 6-17 years, and demonstrated the safety and effectiveness of Aripiprazole in this population.
Key points to consider when using Aripiprazole in ASD treatment include:
- Starting dose: 5 mg/d, with possible increases to 10 or 15 mg/d based on response and tolerability
- Target symptoms: irritability, hyperactivity, stereotypy, social withdrawal, and inappropriate speech
- Demographics: children and adolescents aged 6-17 years
- Monitoring: regular assessments every 3-6 months to evaluate continued need for treatment and potential side effects
It is essential to note that Aripiprazole does not address core autism symptoms, such as social communication deficits or repetitive behaviors, and should be used as part of a comprehensive treatment approach that includes behavioral therapies and educational interventions 1. Additionally, metabolic monitoring is crucial, with regular checks of weight, blood glucose, and lipid levels to minimize potential side effects.
From the FDA Drug Label
Information describing a clinical study in which efficacy was not demonstrated in patients ages 6 to 17 years is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole). The role of Aripiprazole (Abilify) in the treatment of Autism Spectrum Disorder (ASD) is not established, as efficacy was not demonstrated in patients ages 6 to 17 years 2.
From the Research
Role of Aripiprazole in Treating Autism Spectrum Disorder (ASD)
- Aripiprazole, also known as Abilify, has been approved for the treatment of irritability associated with autistic disorder in pediatric patients aged 6-17 years 3, 4, 5.
- The medication has been shown to reduce symptoms of irritability, including aggression and self-injurious behavior, in children and adolescents with ASD 3, 4, 5, 6, 7.
- Studies have demonstrated that aripiprazole is generally well-tolerated in pediatric patients, with most adverse events being mild to moderate in severity 3, 4, 5, 6.
Efficacy of Aripiprazole in Treating Irritability in ASD
- A 52-week, open-label study found that aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years 3.
- Two randomized, controlled trials with efficacy data from nearly 300 patients showed that treatment with aripiprazole was associated with reductions in irritability and global improvements in behavior 4.
- A post-marketing surveillance study in Japan found that aripiprazole was effective in the long-term treatment of irritability associated with ASD in pediatric patients, with a mean change from baseline in the irritability subscale score of -5.7 at week 4 6.
Safety and Tolerability of Aripiprazole in Pediatric Patients
- Aripiprazole was associated with weight gain in both short- and long-term studies, with data indicating that the increase in body weight reached a plateau at 3-6 months 5.
- Common adverse events reported in studies included somnolence, weight increased, and other mild to moderate events 3, 4, 5, 6.
- Experts recommend proper monitoring for metabolic effects and periodic reassessment to determine if ongoing treatment is needed 7.