Indications for Abilify (Aripiprazole) in Pediatric and Adolescent Populations
FDA-Approved Indications
Aripiprazole is FDA-approved for three specific indications in younger populations: irritability associated with autistic disorder (ages 6-17 years), acute manic or mixed episodes in bipolar I disorder (ages 13-17 years in EU, ages 10-17 years in US trials), and schizophrenia (ages 13-17 years). 1, 2
Irritability Associated with Autistic Disorder (Ages 6-17 Years)
Aripiprazole 2-15 mg/day is approved for treating irritability in children and adolescents aged 6-17 years with autistic disorder, demonstrating significant improvements in the Aberrant Behavior Checklist Irritability subscale score compared to placebo after 8 weeks of treatment. 1
The drug showed 56% positive response versus 35% on placebo for irritability in autism, with significant improvements in irritability, hyperactivity, and stereotypy subscales. 3
Aripiprazole does not treat core autism symptoms or social communication deficits and should be accompanied by behavioral interventions. 4
Weight gain is a notable side effect, with increases reaching a plateau at 3-6 months in long-term studies. 1
Bipolar I Disorder - Acute Manic or Mixed Episodes (Ages 13-17 Years)
Aripiprazole 10 mg once daily for 12 weeks is approved in the EU for moderate to severe manic episodes in adolescents aged ≥13 years with bipolar I disorder. 2
The American Academy of Child and Adolescent Psychiatry recommends aripiprazole as a first-line option for acute mania in adolescents, with a favorable metabolic profile compared to olanzapine. 3
Dosing of 5-15 mg/day is effective for acute mania in adults, with similar efficacy expected in adolescents at the 10 mg/day dose. 3, 2
Tolerability was less favorable in younger subjects (10-12 years) than in older subjects (≥13 years), and less favorable with higher dosages (30 mg/day) than lower dosages (10 mg/day). 2
Schizophrenia (Ages 13-17 Years)
Aripiprazole is indicated for schizophrenia in adolescents, though the evidence provided focuses primarily on adult populations. 5, 6
The drug is effective in treating both positive and negative symptoms of schizophrenia with rapid onset of action within one week. 5
Dosing Considerations in Pediatric Populations
Pilot data suggest that a revised dosing strategy based on weight is indicated in children and adolescents, as there is only limited information available on aripiprazole use in this population. 5
For irritability in autism, the dose range is 2-15 mg/day, with gradual titration recommended. 1
For bipolar I disorder in adolescents, 10 mg once daily is the approved dose in the EU, though US trials used flexible dosing. 2
Safety and Tolerability Profile
Aripiprazole is generally well tolerated in pediatric patients, with most adverse events being mild to moderate in severity. 1
Common side effects include sedation, weight gain, and extrapyramidal symptoms (EPS), though the incidence of EPS over 12 weeks at 10 mg/day was not significantly different from placebo. 2
The drug has a low propensity for weight gain compared to other atypical antipsychotics, a favorable metabolic profile, and no association with hyperprolactinemia. 7
Baseline metabolic monitoring must include BMI, waist circumference, blood pressure, fasting glucose, and fasting lipid panel, with follow-up monitoring including BMI monthly for 3 months then quarterly, and blood pressure, fasting glucose, and lipids reassessed at 3 months and annually thereafter. 3
Advantages Over First-Generation Antipsychotics
Second-generation antipsychotics like aripiprazole are preferred over first-generation antipsychotics in pediatric patients with autism and comorbid conditions due to lower risk of extrapyramidal symptoms. 4
Pediatric patients with autism spectrum disorder and intellectual disabilities demonstrate increased sensitivity to extrapyramidal symptoms from first-generation antipsychotics. 4
Common Pitfalls to Avoid
Do not use aripiprazole as monotherapy for core autism symptoms, as it only addresses irritability and associated behavioral problems. 4
Avoid higher dosages (30 mg/day) in younger adolescents due to decreased tolerability without additional therapeutic benefit. 2
Do not discontinue monitoring for metabolic side effects, particularly weight gain, which requires ongoing assessment throughout treatment. 3, 1
Ensure adequate trial duration (8-12 weeks) before concluding ineffectiveness, as some patients may require longer to respond. 2