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Effectiveness of aripiprazole v. haloperidol in acute bipolar mania

Double-blind, randomised, comparative 12-week trial

Clinical Institute of Neuroscience, University of Barcelona, Spain

Michel Bourin, MD

Neurobiologie de l’Anxiété et de la Depression, Faculté de Médecine, Nantes, France

Raymond Sanchez, MD

Bristol-Myers Squibb Co., Wallingford, Connecticut, USA

Ronald Marcus, MD

Bristol-Myers Squibb Co., Wallingford, Connecticut, USA

Elyse Stock, MD

Bristol-Myers Squibb Co., Plainsboro, New Jersey, USA

Robert McQuade, PhD

Bristol-Myers Squibb Co., Lawrenceville, Princeton, New Jersey, USA

William Carson, MD

Otsuka America Pharmaceutical Inc., Princeton, New Jersey, USA

Neveen Abou-Gharbia, PharmD

Bristol-Myers Squibb Co., Lawrenceville, Princeton, New Jersey, USA

Rene Swanink, MSc

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

Taro Iwamoto, PhD

Otsuka Pharmaceutical Co. Ltd, Tokyo, Japan

on behalf of the Aripiprazole Study Group

Correspondence: Dr Eduard Vieta, Director of Research, Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona 08036, Spain. Tel: +34 93 227 5401/5494; e-mail: evieta{at}clinic.ub.es

Declaration of interest This study was sponsored by Bristol-Myers Squibb Company, Princeton, New Jersey, USA, and Otsuka Pharmaceutical Co. Ltd, Tokyo, Japan.

Background Despite several treatmentoptions, adherenceto 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%; 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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BJP 2005 187: 203. [Full Text]  

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				C. F. Baldassano Management of Bipolar Disorder in the Acute and Maintenance Settings Journal of the American Psychiatric Nurses Association, November 1, 2007; 13(5_suppl): S16 - S22. [Abstract] [PDF]

				H. Scherk, F. G. Pajonk, and S. Leucht Second-Generation Antipsychotic Agents in the Treatment of Acute Mania: A Systematic Review and Meta-analysis of Randomized Controlled Trials Arch Gen Psychiatry, April 1, 2007; 64(4): 442 - 455. [Abstract] [Full Text] [PDF]

				G. S. Sachs Bipolar Disorder Clinical Synthesis: Where Does the Evidence Lead? Focus, January 1, 2007; 5(1): 3 - 13. [Abstract] [Full Text] [PDF]

				R. M. A. Hirschfeld Guideline Watch (November 2005): Practice Guideline for the Treatment of Patients with Bipolar Disorder, 2nd Edition Focus, January 1, 2007; 5(1): 34 - 39. [Abstract] [Full Text] [PDF]

				Bibliography BIPOLAR DISORDER Focus, January 1, 2007; 5(1): 40 - 43. [Full Text] [PDF]

				P. TYRER The British Journal of Psychiatry, October 1, 2006; 189(4): 390 - 390. [Full Text] [PDF]

				F. Centorrino Aripiprazole reduces acute mania compared with haloperidol in bipolar I disorder and causes fewer adverse effects. Evid. Based Ment. Health, May 1, 2006; 9(2): 41 - 41. [Full Text] [PDF]

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