JAMDA
Volume 10, Issue 1 , Pages 21-27 , January 2009

A Randomized, Double-Blind, Placebo-Controlled Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients With Alzheimer's, Vascular, or Mixed Dementia

Data from this manuscript were presented as a poster at the American Psychiatric Association Annual Meeting in June 2007.

  • Stephen A. Rappaport, MD

      Affiliations

    • Agewell® Health, Indianapolis, IN
    • Corresponding Author InformationAddress correspondence to Stephen A. Rappaport, MD, Agewell® Health, 9292 North Meridian Street, Suite 107, Indianapolis, IN 46260
    • ,
  • Ronald N. Marcus, MD

      Affiliations

    • Bristol-Myers Squibb, Wallingford, CT
    • ,
  • George Manos, PhD

      Affiliations

    • Bristol-Myers Squibb, Wallingford, CT
    • ,
  • Robert D. McQuade, PhD

      Affiliations

    • Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
    • ,
  • Dan A. Oren, MD

      Affiliations

    • Bristol-Myers Squibb, Wallingford, CT

References 

  1. US Food and Drug Administration. FDA Public Health Advisory (Deaths with antipsychotics in elderly patients with behavioral disturbances). Rockville, MD: US Food & Drug Administration; 2005;
  2. Wooltorton E. Risperidone (Risperdal): Increased rate of cerebrovascular events in dementia trials. CMAJ. 2002;167:1269–1270
  3. Wooltorton E. Olanzapine (Zyprexa): Increased incidence of cerebrovascular events in dementia trials. CMAJ. 2004;170:1395
  4. US Food and Drug Adminstration. 2003 safety alert: risperidone (Risperdal). Rockville, MD: US Food and Drug Administration; 2003;[Dear Healthcare Professional Letter]. April 16, 2003
  5. MHRA. Summary of clinical trial data on cerebrovascular adverse events (CVAEs) in randomised clinical trials of risperidone conducted in patients with dementia. http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019490.pdf2004;Accessed June 1, 2008
  6. Health Canada advises consumers about important safety information on atypical antipsychotic drugs and dementia. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_63_e.html2005;Accessed June 1, 2008
  7. Herrmann N, Mamdani M, Lanctot KL. Atypical antipsychotics and risk of cerebrovascular accidents. Am J Psychiatry. 2004;161:1113–1115
  8. Finkel S, Kozma C, Long S, et al. Risperidone treatment in elderly patients with dementia: Relative risk of cerebrovascular events versus other antipsychotics. Int Psychogeriatr. 2005;17:617–629
  9. Wang PS, Schneeweiss S, Avorn J, et al. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005;353:2335–2341
  10. 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
  11. Jordan S, Koprivica V, Chen R, et al. The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT(1A) receptor. Eur J Pharmacol. 2002;441:137–140
  12. Streim J, Breder C, Swanink R, et al. Flexible dose aripiprazole in psychosis of Alzheimer's Dementia. Paper presented at: Annual Meeting of the American Psychiatric Association; May 1–4, 2004; New York, NY.
  13. De Deyn P, Jeste DV, Swanink R, et al. Aripiprazole for the treatment of psychosis in patients with Alzheimer's Disease: A randomized, placebo-controlled study. J Clin Psychopharmacol. 2005;25:463–467
  14. Mintzer JE, Tune LE, Breder CD, et al. Aripiprazole for the treatment of psychoses in institutionalized patients with Alzheimer dementia: a multicenter, randomized, double-blind, placebo-controlled assessment of three fixed doses. Am J Geriatr Psychiatry. 2007;15:918–931
  15. Andrezina R, Josiassen R, Marcus R, et al. Intramuscular aripiprazole for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: A double-blind, placebo-controlled comparison with IM haloperidol. Psychopharmacology. 2006;188:281–292
  16. Tran-Johnson T, Sack D, Marcus R, et al. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation. J Clin Psychiatry. 2006;68:111–119
  17. Zimbroff DL, Marcus RN, Manos G, et al. Management of acute agitation in patients with bipolar disorder: Efficacy and safety of intramuscular aripiprazole. J Clin Psychopharmacol. 2007;27:171–176
  18. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). 4th ed.. Washington, DC: American Psychiatric Association; 1994;
  19. Meehan K, Zhang F, David S, et al. A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania. J Clin Psychopharmacol. 2001;21:389–397
  20. Meehan KM, Wang H, David SR, et al. Comparison of rapidly acting intramuscular olanzapine, lorazepam, and placebo: A double-blind, randomized study in acutely agitated patients with dementia. Neuropsychopharmacology. 2002;26:494–504
  21. Lindenmayer JP, Brown E, Baker RW, et al. An excitement subscale of the Positive and Negative Syndrome Scale. Schizophr Res. 2004;68:331–337

 This study was supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan). Editorial support for the preparation of this manuscript was provided by Ogilvy Healthworld Medical Education; funding was provided by Bristol-Myers Squibb.

PII: S1525-8610(08)00253-3

doi: 10.1016/j.jamda.2008.06.006

JAMDA
Volume 10, Issue 1 , Pages 21-27 , January 2009

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