Effectiveness of aripiprazole v. haloperidol in acute bipolar mania - Double-blind, randomised, comparative 12-week trial

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 (>= 50% 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%; halopericlol, 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. Declaration of interest This study was sponsored by Bristol-Myers Squibb Company, Princeton, New Jersey, USA, and Otsuka Pharmaceutical Co. Ltd, Tokyo, Japan.