Aripiprazole: A Review of Its Use in the Treatment of Manic Episodes in Adolescents with Bipolar I Disorder

Abstract

Aripiprazole (Abilify(®)) is an atypical antipsychotic that is widely used in the treatment of psychiatric conditions. Unlike other currently available atypical antipsychotics that primarily have varying degrees of dopamine D2 receptor antagonism, aripiprazole is a partial agonist at D2 and serotonin 5-HT1A receptors, which may explain differences in tolerability profiles. Recently in the EU, oral aripiprazole 10 mg once daily for 12 weeks was approved for the treatment of moderate to severe manic episodes in adolescents (aged ≥13 years) with bipolar I disorder. Approval was based on a phase 3, 30-week US trial in children and adolescents with bipolar I disorder experiencing manic or mixed episodes. Using trial data together with ancillary analyses, the European Medicines Agency concluded that aripiprazole 10 mg once daily for 12 weeks was effective in reducing symptoms of mania, but because of the high drop-out rate, efficacy over 30 weeks of treatment was not proven. Aripiprazole was generally well tolerated in the phase 3 trial. Ancillary analyses indicated that tolerability was less favourable in younger (10-12 years) than in older (≥13 years) subjects, and less favourable with the higher (30 mg/day) than the lower dosage (10 mg/day). The drug is associated with sedation, weight gain and extrapyramidal symptoms (EPS), although the incidence of EPS over 12 weeks was not significantly different between aripiprazole 10 mg/day and placebo. Data comparing the use of atypical antipsychotics in the treatment of mania in adolescents with bipolar I disorder are limited, but evidence shows that aripiprazole provides a valuable additional therapeutic option for use in this population.