The primary objective of this FDA-requested study was to examine the tolerability/safety and pharmacokinetics (PK) of 20 mg, 25 mg, and 30 mg per day of aripiprazole in children and adolescents, ages 10-17. Effectiveness of aripiprazole was also assessed in this patient population, and is described as the focus of this poster.

This was an open-label, 26-day, multi-center, sequential cohort, dose-escalation trial. Twenty-one (21) children and adolescents, aged 10 to 17 years old, were enrolled. Preferential enrollment was given to patients with schizophrenia or bipolar illness; however, other psychiatric diagnoses were also permitted. Fifty-seven percent (57%) of patients were diagnosed with bipolar disorder; 24%, Tourette's disorder; and 5%, schizophrenia, PDD, OCD, or conduct disorder. Patients started on a dose of aripiprazole 2 mg/day. Three cohorts reached final doses of 20, 25, or 30 mg/day over a maximum of 12 days and maintained that dose for an additional 14 days. Effectiveness was assessed using the CGI-Severity and CGI-Improvement scales.

Eighty-five percent (17/20) of the patients were “much improved” or “very much improved” at study endpoint (CGI-I).

Conclusions:

1. • Effectiveness of aripiprazole at doses of 20-30 mg/day is demonstrated in this child and adolescent patient population

2. • Observation of clinically meaningful improvement of global symptoms supports systematic evaluation in pediatric/adolescent disorders