Background Despite several treatment options, adherence to therapy is poor in patients with bipolar disorder. Aims A double-blind, controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes. Method Patients ( n =347) were randomised to receive aripiprazole or haloperidol in this 12-week, multicentre study. The primary outcome measure was the number of patients in response (550% improvement from baseline in Young Mania Rating Scale score) and receiving therapy at week 12. Results At week 12, significantly more patients taking aripiprazole (49. 7%) were in response and receiving therapy compared with those taking haloperidol (28. 4%; P <0. 001). Continuation rates differed markedly between treatments (week 12: aripiprazole, 50. 9%; haloperidol, 29. 1%). Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (62. 7% v. 24. 0%). Conclusions Aripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks.
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