Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

摘要

Background Well-tolerated and effective therapies for bipolar mania are required. Aims To evaluate the efficacy and tolerability of aripiprazole as acute and maintenance of effect therapy in patients with bipolar I disorder experiencing manic or mixed episodes. Method Patients were randomised to double-blind aripiprazole (15 or 30 mg/day; n =167), placebo ( n =153) or haloperidol (5a€“15 mg/day, n =165) for 3 weeks (trial registration [NCT00097266][1]). Aripiprazole- and haloperidol-treated patients remained on masked treatment for 9 additional weeks. Results Mean change in Young Mania Rating Scale Total score (primary end-point) at week 3 was significantly greater with aripiprazole (a€“12.0; P 0.05) and haloperidol (a€“12.8; P 0.01) than with placebo (a€“9.7). Improvements were maintained to week 12 for aripiprazole (a€“17.2) and haloperidol (a€“17.8). Aripiprazole was well tolerated. Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (53.3% v . 23.5%). Conclusions Clinical improvements with aripiprazole were sustained to week 12. Aripiprazole was generally well tolerated. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00097266&atom=%2Fbjprcpsych%2F194%2F1%2F40.atom