Doses of the antipsychotic should be titrated as follows: 2mg daily for 2 days then 5mg daily for 2 days, followed by the usual maintenance dose of 10mg once daily for a maximum duration of 12 weeks.
The efficacy of aripiprazole in this setting was demonstrated in a 30-week, placebo-controlled study in 296 children and adolescents aged 10–17 years, who met DSM-IV criteria for bipolar I disorder with manic or mixed episodes, with or without psychotic features, and had a Young Mania Rating Scale (YMRS) score ≥20 at baseline.
Patients were randomised to receive aripiprazole 10mg or 30mg daily or placebo and were assessed for change in YMRS score at week 4 as the primary endpoint. After 4 weeks, acute treatment completers continued treatment for up to a further 26 weeks.
Superior to placebo at both doses
Both doses of aripiprazole were superior to placebo in terms of YMRS total score change from baseline at week 4 and 12 (both p<0.001). However, evidence for prevention of recurrence was not established and completion rates were low in all treatment arms.
Further information: Otsuka