Effectiveness of aripiprazole v. haloperidol in acute bipolar mania: double-blind, randomised, comparative 12-week trial

Br J Psychiatry. 2005 Sep;187:235-42. doi: 10.1192/bjp.187.3.235.

Abstract

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 (greater, similar 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Aripiprazole
  • Bipolar Disorder / drug therapy*
  • Body Weight / drug effects
  • Double-Blind Method
  • Electrocardiography / drug effects
  • Female
  • Haloperidol / adverse effects
  • Haloperidol / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Patient Dropouts
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Prolactin / blood
  • Psychiatric Status Rating Scales
  • Quinolones / adverse effects
  • Quinolones / therapeutic use*
  • Treatment Outcome

Substances

  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole
  • Prolactin
  • Haloperidol