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.