Hostname: page-component-848d4c4894-wg55d Total loading time: 0 Render date: 2024-05-25T12:36:57.110Z Has data issue: false hasContentIssue false
  • English
  • Français

The Efficacy and Safety of Lower Doses of Aripiprazole for the Treatment of Patients with Acute Exacerbation of Schizophrenia

Published online by Cambridge University Press:  07 November 2014

Andrew J. Cutler ,
Ronald N. Marcus ,
Sterling A. Hardy ,
Amy O'Donnell ,
William H. Carson  and
Robert D. McQuade
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction

Efficacy and safety of aripiprazole administered at doses lower than those previously studied systematically were investigated in patients with acute exacerbation of schizophrenia.

Methods

In this double-blind, multicenter study, 367 patients requiring inpatient hospitalization for acute relapse of schizophrenia were randomized to one of three fixed doses of aripiprazole (2, 5, or 10 mg/day) or placebo for 6 weeks. Efficacy and safety parameters were assessed weekly. Primary outcome measure was mean change from baseline in Positive and Negative Syndrome Scale (PANSS)Total score at endpoint.

Results

Aripiprazole 10 mg/day produced statistically significantly greater improvements from baseline compared with placebo for PANSS Total at endpoint (−11.3 vs −5.3; P=.03) and at weeks 2–5. Aripiprazole 5 mg/day did not produce significantly greater improvement in PANSS Total compared with placebo at endpoint, although significant differences were seen at weeks 3–5. No statistically significant improvements compared with placebo were achieved with aripiprazole 2 mg/day at any time points. All aripiprazole doses were well tolerated. Aripiprazole was not associated with significant extrapyramidal symptoms.

Conclusion

While aripiprazole 5 mg/day warrants further study, the 10 mg/day dose provides effective and well-tolerated therapy for management of acute psychosis in patients with schizophrenia.

Type
Original Research
Information
CNS Spectrums , Volume 11 , Issue 9 , September 2006 , pp. 691 - 702
Copyright
Copyright © Cambridge University Press 2006

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Burris, KD, Molski, TF, Xu, C, et al. Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther. 2002;302:381–389.Google Scholar
2. Kane, JM, Carson, WH, Saha, AR, et al. Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2002;63:763–771.Google Scholar
3. Potkin, SG, Saha, AR, Kujawa, MJ, et al. Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2003;60:681–690.Google Scholar
4. Lieberman, J, Carson, WH, Saha, AR, et al. Meta-analysis of the efficacy of aripiprazole in schizophrenia. Int J Neuropsychopharmacol. 2002;5(suppl 1):S186.Google Scholar
5. Ability [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Co & Otsuka America Pharmaceutical, Inc; 2002.Google Scholar
6. Marder, SR, McQuade, RD, Stock, E, et al. Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials. Schizophr Res. 2003;61:123–136.Google Scholar
7. Pigott, TA, Carson, WH, Saha, AR, Torbeyns, AF, Stock, EG, Ingenito, GG. Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebocontrolled 26-week study. J Clin Psychiatry. 2003;64:1048–1056.Google Scholar
8. Kasper, S, Lerman, MN, McQuade, RD, et al. Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia. Int J Neuropsychopharmacol. 2003;6:325–337.Google Scholar
9. McQuade, RD, Stock, E, Marcus, R, et al. A comparison of weight change during treatment with olanzapine or aripiprazole: results from a randomized, double-blind study. J Clin Psychiatry. 2004;65(suppl 18):47–56.Google Scholar
10. Daniel, DG, Saha, AR, Ingenito, G, Carson, WH, Dunbar, G. Aripiprazole, a novel antipsychotic: overview of a phase 2 study result. Int J Neuropsychopharmacol. 2000;3(suppl 1):S157.Google Scholar
11. Dillenschneider, A, Marcus, R, Kostic, D, et al. Short and long-term effects of aripiprazole treatment on the excitement/hostility symptoms of schizophrenia. Int J Neuropsychopharmacology. 2004;7(suppl 1):S243, abstract P201.424.Google Scholar
12. Yokoi, F, Grunder, G, Biziere, K, et al. Dopamine D2 and D3 receptor occupancy in normal humans treated with the antipsychotic drug aripiprazole (OPC 14597): a study using positron emission tomography and [11C]raclopride. Neuropsychopharmacology. 2002;12:248–259.Google Scholar
13. Farde, L, Nordstrom, AL, Wiesel, FA, Pauli, S, Halldin, C, Sedvall, G. Positron emission tomographic analysis of central D1 and D2 dopamine receptor occupancy in patients treated with classical neuroleptics and clozapine. Relation to extrapyramidal side effects. Arch Gen Psychiatry. 1992;49:538–544.Google Scholar
14. Tauscher, J, Kapur, S. Choosing the right dose of antipsychotics in schizophrenia: lessons from neuroimaging studies. CNS Drugs. 2001;15:671–678.Google Scholar
15. Worrel, JA, Marken, PA, Beckman, SE, Ruehter, VL. Atypical antipsychotic agents: a critical review. Am J Health Syst Pharm. 2000;57:238–255.Google Scholar
16. Nemeroff, CB. Dosing the antipsychotic medication olanzapine. J Clin Psychiatry. 1997;58(suppl 10):45–49.Google Scholar
17. Beasley, CM Jr, Tollefson, GD, Tran, PV. Safety of olanzapine. J Clin Psychiatry. 1997;58(suppl 10):13–17.Google Scholar
18. Daniel, DG, Zimbroff, DL, Potkin, SG, Reeves, KR, Harrigan, EP, Lakshminarayanan, M. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone Study Group. Neuropsychopharmacology. 1999;20:491–505.Google Scholar
19. Arvanitis, LA, Miller, BG. Multiple fixed doses of “Seroquel” (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. The Seroquel Trial 13 Study Group. Biol Psychiatry. 1997;42:233–246.Google Scholar
20. Kampman, O, Laippala, P, Vaananen, J, et al. Indicators of medication compliance in first-episode psychosis. Psychiatry Res. 2002;110:39–48.Google Scholar
21. Perkins, DO. Predictors of noncompliance in patients with schizophrenia. J Clin Psychiatry. 2002;63:1121–1128.Google Scholar