Efficacy and Safety of Aripiprazole and Haloperidol Versus Placebo in Patients With Schizophrenia and Schizoaffective Disorder
J Clin Psychiatry 2002;63(9):763-771
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Aripiprazole is an
investigational agent for treating schizophrenia that has a
novel pharmacologic profile. The present study
investigated the efficacy, safety, and tolerability
of aripiprazole and haloperidol compared with placebo.
Method: A 4-week, double-blind,
randomized study, conducted at 36 U.S. centers between
July 1997 and June 1998, compared aripiprazole (15
mg/day, 30 mg/day) to placebo, with haloperidol
(10 mg/day) as an active control. Fixed doses of
each agent were administered from day 1 throughout
the study. A total of 414 patients with a primary
DSM-IV diagnosis of schizophrenia or
schizoaffective disorder were randomized. Efficacy measures
included the Positive and Negative Syndrome Scale (PANSS) total, PANSS positive, PANSS
negative, PANSS-derived Brief Psychiatric Rating
Scale (BPRS) core, Clinical Global Impressions
(CGI)-Severity of Illness, and mean
CGI-Improvement scores. Safety and tolerability evaluations
included extrapyramidal symptoms (EPS), weight gain,
serum prolactin level, and QTc interval.
Results: Both doses of aripiprazole and
haloperidol, 10 mg, produced statistically
significant (p<=.05) improvements from baseline in
PANSS total, PANSS positive, PANSS-derived BPRS
core, and CGI-Severity scores and significantly
lower CGI-Improvement scores at endpoint, compared with placebo. Aripiprazole, 15 mg, and
haloperidol, 10 mg, significantly improved PANSS
negative score compared with placebo. Both
aripiprazole doses and haloperidol separated from placebo
for PANSS total scores at week 2. Unlike
haloperidol, aripiprazole was not associated with significant
EPS or prolactin elevation at endpoint compared
with placebo. There were no statistically significant
differences in mean changes in body weight across
the treatment groups versus placebo, and no
patients receiving aripiprazole experienced clinically
significant increases in QTc interval.
Conclusion: Aripiprazole, effective against
positive and negative symptoms, is a safe and
well-tolerated potential treatment for schizophrenia
and schizoaffective disorder.