Commercial Names of Aripiprazole
Aripiprazole is marketed under the brand name Abilify® 1, 2, 3, 4, 5.
FDA-Approved Indications for Adolescents (13-17 Years)
For your specific patient population (13-17 year old adolescent with paranoia), aripiprazole has the following FDA approvals:
- Aripiprazole is FDA-approved for the treatment of schizophrenia in adolescents aged 13 to 17 years 1.
- The efficacy was established in a 6-week, placebo-controlled trial in 302 adolescent patients (13-17 years) with schizophrenia, where both 10 mg/day and 30 mg/day doses were superior to placebo 1.
- The 30 mg/day dosage was not shown to be more efficacious than the 10 mg/day dose in adolescents 1.
Recommended Dosing for Adolescents
- For adolescents with schizophrenia, aripiprazole should be initiated at 2 mg/day, titrated to the target dose of 10 mg/day over 5 days 1.
- The 10 mg/day dose represents the optimal balance of efficacy and tolerability in this age group 1.
- Although 30 mg/day was also studied, it provided no additional therapeutic benefit over 10 mg/day and may be associated with less favorable tolerability 3.
Clinical Context for Paranoia
- Paranoia in adolescents may represent positive symptoms of schizophrenia or schizoaffective disorder, for which aripiprazole has demonstrated efficacy 4, 5.
- Aripiprazole is effective in treating both positive symptoms (including paranoia) and negative symptoms of schizophrenia 2, 4.
- The drug shows rapid onset of action, with clinical effects observable within the first week of treatment 2, 4.
Important Safety Considerations for Adolescents
- Aripiprazole has a more favorable metabolic profile compared to other atypical antipsychotics, with lower propensity for weight gain 4, 5.
- The incidence of extrapyramidal symptoms (EPS) at 10 mg/day over 12 weeks was not significantly different from placebo in adolescents 3.
- Tolerability data indicate that younger adolescents (10-12 years) experienced less favorable tolerability than older adolescents (≥13 years) 3.