© 2005 The Royal College of Psychiatrists
Effectiveness of aripiprazole v. haloperidol in acute bipolar mania
Double-blind, randomised, comparative 12-week trial
Clinical Institute of Neuroscience, University of Barcelona, Spain
Neurobiologie de l’Anxiété et de la Depression, Faculté de Médecine, Nantes, France
Bristol-Myers Squibb Co., Wallingford, Connecticut, USA
Bristol-Myers Squibb Co., Wallingford, Connecticut, USA
Bristol-Myers Squibb Co., Plainsboro, New Jersey, USA
Bristol-Myers Squibb Co., Lawrenceville, Princeton, New Jersey, USA
Otsuka America Pharmaceutical Inc., Princeton, New Jersey, USA
Bristol-Myers Squibb Co., Lawrenceville, Princeton, New Jersey, USA
Bristol-Myers Squibb Co., Braine l’Alleud, Belgium
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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