The British Journal of Psychiatry (2009) 194: 40-48. doi: 10.1192/bjp.bp.108.049965
© 2009 The Royal College of Psychiatrists
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Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

Allan H. Young, FRCPsych

Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, Canada

Dan A. Oren, MD

Bristol-Myers Squibb, Wallingford, Connecticut, USA

Adam Lowy, MD

Comprehensive NeuroScience Inc, Northwest, Washington DC, USA

Robert D. McQuade, PhD

Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA

Ronald N. Marcus, MD

Bristol-Myers Squibb, Wallingford, Connecticut, USA

William H. Carson, MD

Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA

Nina H. Spiller, PharmD

Bristol-Myers Squibb, Wallingford, Connecticut, USA

Anne F. Torbeyns, PhD

Bristol-Myers Squibb, Braine-l’Alleud, Belgium

Raymond Sanchez, MD

Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey, USA

Correspondence: Allan H. Young, LEEF Chair and Co-Director, Institute of Mental Health, Department of Psychiatry, University of British Columbia, Suite 430–5950 University Boulevard, Vancouver, BC V6T 1Z3, Canada. Email: allanyoun{at}gmail.com

Declaration of interest

This study was supported by Bristol-Myers Squibb (Princeton, New Jersey) and Otsuka Pharmaceutical Co., Ltd (Tokyo, Japan). A.H.Y received speaker fees from numerous pharmaceutical companies, including Bristol-Myers Squibb, for lecturing on this topic. A.L. received speaker fees from Eli Lilly, AstraZeneca and Pfizer. R.D.McQ., R.S. and W.H.C. are employees of Otsuka Pharmaceutical Development & Commercialization Inc. D.A.O., R.N.M., N.H.S. and A.F.T. are employees of Bristol-Myers Squibb.

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.


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