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Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.

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

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  • 1Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, Canada. allanyoun@gmail.com

Abstract

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 (5-15 mg/day, n=165) for 3 weeks (trial registration NCT00097266). 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 (-12.0; P<0.05) and haloperidol (-12.8; P<0.01) than with placebo (-9.7). Improvements were maintained to week 12 for aripiprazole (-17.2) and haloperidol (-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.

PMID:
19118324
DOI:
10.1192/bjp.bp.108.049965
[PubMed - indexed for MEDLINE]
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