Aripiprazole for the Prevention of Relapse in Stabilized Patients With Chronic Schizophrenia: A Placebo-Controlled 26-Week Study
J Clin Psychiatry 2003;64(9):1048-1056
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Aripiprazole is a novel
antipsychotic for the management of schizophrenia. This study
investigated the efficacy, safety, and tolerability of
aripiprazole in preventing relapse in adult chronic schizophrenia
patients experiencing ongoing stable symptomatology.
Method: In this 26-week, randomized,
double-blind, placebo-controlled, parallel-group, multicenter
study, 310 patients with DSM-IV schizophrenia (mean Positive and
Negative Syndrome Scale [PANSS] total score = 82) were randomly
assigned to receive a once-daily fixed dose of aripiprazole, 15
mg, or placebo. The primary outcome measure was time to relapse
following randomization. Secondary objectives were to assess the
efficacy, safety, and tolerability of aripiprazole, 15 mg,
compared with placebo, in the study population. The study was
conducted between Dec. 21, 2000, and Aug. 20, 2001.
Results: The time to relapse following
randomization was significantly (p < .001) longer for
aripiprazole compared with placebo. More patients relapsed with
placebo (N = 85; 57%) than aripiprazole (N = 50; 34%); the
relative risk of relapse for the aripiprazole group was 0.59 (p
< .001). Aripiprazole was significantly superior to placebo
from baseline to endpoint in PANSS total, PANSS positive,
PANSS-derived Brief Psychiatric Rating Scale, and Clinical Global
Impressions-Severity of Illness scale (CGI-S) scores and
demonstrated significantly better mean Clinical Global
Impressions-Global Improvement scale scores (p <= .01 for all
comparisons except CGI-S: .01 < p <= .05). Aripiprazole was
well tolerated, with no evidence of marked sedation and no
evidence of hyperprolactinemia or prolonged heart rate-corrected
QT interval (QTc). Extrapyramidal symptoms were comparable in the
aripiprazole and placebo groups. Modest mean weight loss at
endpoint was evident in both groups.
Conclusion: Aripiprazole, 15 mg once daily, is
an effective, well-tolerated treatment for prevention of relapse
in patients with chronic, stable schizophrenia.