Aripiprazole for patients with schizophrenia and schizoaffective disorder: an open-label, randomized, study versus haloperidol.
BACKGROUND
Aripiprazole, a dopamine D2 receptor partial agonist, has also partial agonist activity at serotonin (5-HT)1A receptors and antagonist activity at 5-HT2A receptors.


METHODS
In this 8-week, multicenter, randomized, parallel-group, open-label, flexible-dose study, patients diagnosed with schizophrenia or schizoaffective disorder were randomized to aripiprazole 15-30 mg/day or haloperidol 10-15 mg/day.


RESULTS
Patients treated with both aripiprazole and haloperidol improved from baseline in Positive and Negative Syndrome Scale total, positive, and negative scores as well as in Clinical Global Impressions scores (all P<.001). At the end of the study, the percentage of patients classified as responders--according to >or=40% reduction in the Positive and Negative Syndrome Scale negative subscale score--was significantly higher in the aripiprazole group (20%) than in the haloperidol group (0%) (P<.05). Additionally, a higher number of patients receiving haloperidol required more anticholinergic medications (P<.001) than aripiprazole-treated patients, whereas more aripiprazole (45.5%) than haloperidol-treated patients (12.9%) required benzodiazepines (P=.002). At endpoint, rates of preference of medication were higher in the aripiprazole group (63.2%) than in the haloperidol group (21.7%), as expressed by patients and caregivers (P=.001).


CONCLUSIONS
Aripiprazole and haloperidol had similar efficacy in terms of reduction of overall psychopathology. Although aripiprazole has been demonstrated to be superior concerning negative symptoms and in terms of tolerability (extrapyramidal symptoms) and preferred by patients and caregivers than haloperidol, significantly more aripiprazole-treated patients required benzodiazepines.
de Oliveira
Irismar Reis
IR
Department of Neurosciences and Mental Health, Federal University of Bahia, Bahia, Brazil. irismar.oliveira@uol.com.br
Elkis
Hélio
H
Gattaz
Wagner Farid
WF
Chaves
Ana  Cristina
A
de Sena
Eduardo Pondé
EP
de Matos E Souza
Fabio Gomes
FG
Campos
João Alberto
JA
Bueno
João Romildo
JR
E Silva
Jorge Alberto Costa
JA
Louzã
Mário Rodrigues
MR
de Abreu
Paulo Belmonte
PB
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068180:Aripiprazole; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011618:Psychotic Disorders / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D006220:Haloperidol