The primary objective of this FDA-requested study was to examine the tolerability, safety, and pharmacokinetics (PK) of 20, 25, and 30 mg/day of aripiprazole in children and adolescents, ages 10-17.

21 patients were enrolled in this open-label, sequential cohort trial that employed a forced escalation paradigm. A 2 mg starting dose was increased to 5, 10, 15, 20, 25, or 30 mg (depending on the final dose) in 2-day, stepwise intervals. After this initial dose-escalation phase, subjects were maintained at their target dose for an additional 14 days. Study medication was given once daily. Preferential enrollment was given to patients with schizophrenia or bipolar illness. Blood samples were collected for aripiprazole concentrations.

Using the described dose-escalation schedule, all 3 dose levels were well tolerated, in general. One subject discontinued treatment due to acute, moderate dystonia. Other adverse events were in the mild/moderate range and were transient in nature. Aripiprazole pharmacokinetics are linear across doses and similar to that observed in adult patients.

Conclusions:

• • Doses of 20, 25 and 30 mg/day (following titration from a starting dose of 2 mg) are generally well tolerated in children and adolescents without regard to gender or psychiatric diagnosis.

• • Aripiprazole pharmacokinetics are linear in child and adolescent patients.