Journal of Affective Disorders
Volume 122, Issue 1 , Pages 27-38 , April 2010

Asenapine in the treatment of acute mania in bipolar I disorder: A randomized, double-blind, placebo-controlled trial

  • Roger S. McIntyre

      Affiliations

    • University of Toronto, Toronto, ON, Canada
    • Corresponding Author InformationCorresponding author. University of Toronto, University Health Network, 399 Bathurst Street, MP 9-325, Toronto, ON, Canada M5T 2S8. Tel.: +1 416 603 5279; fax: +1 416 603 5368.
  • ,
  • Miriam Cohen

      Affiliations

    • Merck, Summit, NJ, United States
  • ,
  • Jun Zhao

      Affiliations

    • Merck, Summit, NJ, United States
  • ,
  • Larry Alphs

      Affiliations

    • Employed at Pfizer Global Research and Development, Ann Arbor, MI, United States, at the time of this study
  • ,
  • Thomas A. Macek

      Affiliations

    • Employed at Pfizer Global Research and Development, Ann Arbor, MI, United States, at the time of this study
  • ,
  • John Panagides

      Affiliations

    • Merck, Summit, NJ, United States

Received 13 October 2009 ,Revised 15 December 2009 ,Accepted 29 December 2009.

References 

  1. Ahmad S, Beckett MW. Value of serum prolactin in the management of syncope. Emerg. Med. J. 2004;21:e3
  2. Baldessarini RJ, Leahy L, Arcona S, Gause D, Zhang W, Hennen J. Patterns of psychotropic drug prescription for U.S. patients with diagnoses of bipolar disorders. Psychiatr. Serv. 2007;58:85–91
  3. Barnes SA, Mallinckrodt CH, Lindborg SR, Carter MK. The impact of missing data and how it is handled on the rate of false-positive results in drug development. Pharm. Stat. 2008;7:215–225
  4. Bowden CL. Making optimal use of combination pharmacotherapy in bipolar disorder. J. Clin. Psychiatry. 2004;65(Suppl 15):21–24
  5. Calvert NW, Burch SP, Fu AZ, Reeves P, Thompson TR. The cost-effectiveness of lamotrigine in the maintenance treatment of adults with bipolar I disorder. J. Manag. Care Pharm. 2006;12:322–330
  6. Chisholm D, van Ommeren M, Ayuso-Mateos JL, Saxena S. Cost-effectiveness of clinical interventions for reducing the global burden of bipolar disorder. Br. J. Psychiatry. 2005;187:559–567
  7. Chue P, Jones B, Taylor CC, Dickson R. Dissolution profile, tolerability, and acceptability of the orally disintegrating olanzapine tablet in patients with schizophrenia. Can. J. Psychiatry. 2002;47:771–774
  8. Chue P, Welch R, Binder C. Acceptability and disintegration rates of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder. Can. J. Psychiatry. 2004;49:701–703
  9. Chue P, Prinzo RS, Binder CE. Do formulation switches exacerbate existing medical illness? Results of an open-label transition to orally disintegrating risperidone tablets. Hum. Psychopharmacol. 2007;22:307–314
  10. Cipriani A, Rendell JM, Geddes J. Olanzapine in long-term treatment for bipolar disorder. Cochrane Database Syst. Rev. 2009;CD004367:
  11. Cousins DA, Young AH. The armamentarium of treatments for bipolar disorder: a review of the literature. Int. J. Neuropsychopharmacol. 2007;10:411–431
  12. Dogterom P, Hulskotte EGJ, Gerrits MGF, Timmer C, Ad Sitsen JM, de Greef HJMM, et al. Asenapine pharmacokinetics: influence of cytochrome P450 modulators and UDP-glucuronyltransferase inhibition. In: Presented at: 21st Congress European College of Neuropsychopharmacology; February 3–7, 2008; Barcelona, Spain. 2008;
  13. Duffy FF, Narrow WE, Rae DS, West JC, Zarin DA, Rubio-Stipec M, et al. Concomitant pharmacotherapy among youths treated in routine psychiatric practice. J. Child Adolesc. Psychopharmacol. 2005;15:12–25
  14. Eaddy M, Grogg A, Locklear J. Assessment of compliance with antipsychotic treatment and resource utilization in a Medicaid population. Clin. Ther. 2005;27:263–272
  15. Fountoulakis KN, Vieta E. Treatment of bipolar disorder: a systematic review of available data and clinical perspectives. Int. J. Neuropsychopharmacol. 2008;11:999–1029
  16. Gerrits MGF, Doorstam DP, Spaans E, de Greef HJMM, Peeters PAM. Effect of valproate on the glucuronidation of asenapine. Clin. Pharmacol. Ther. 2008;83:S29
  17. Guy W. Clinical global impressions. In:  Guy W editors. Clinical Global Impressions. Washington, DC: U.S. Department of Health, Education, and Welfare; 1976;p. 217–222
  18. Hirschfeld RM, Keck PE, Kramer M, Karcher K, Canuso C, Eerdekens M, et al. Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am. J. Psychiatry. 2004;161:1057–1065
  19. Hulskotte EGF, Gerrits MGF, Timmer C, Doorstam D, Huisman JAM, De Greef HJMM, et al. Increased single-dose concentrations of paroxetine after coadministration of the modest CYP2D6 inhibitor asenapine. Clin. Pharmacol. Ther. 2008;83:S28
  20. Jennex A, Gardner DM. Monitoring and management of metabolic risk factors in outpatients taking antipsychotic drugs: a controlled study. Can. J. Psychiatry. 2008;53:34–42
  21. Judd LL, Akiskal HS, Schettler PJ, Endicott J, Leon AC, Solomon DA, et al. Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study. Arch. Gen. Psychiatry. 2005;62:1322–1330
  22. Keck PE, Versiani M, Potkin S, West SA, Giller E, Ice K. Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am. J. Psychiatry. 2003;160:741–748
  23. Keck PE, Marcus R, Tourkodimitris S, Ali M, Liebeskind A, Saha A, et al. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am. J. Psychiatry. 2003;160:1651–1658
  24. Ketter TA, Haupt DW. Perceptions of weight gain and bipolar pharmacotherapy: results of a 2005 survey of physicians in clinical practice. Curr. Med. Res. Opin. 2006;22:2345–2353
  25. Lane P. Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches. Pharm. Stat. 2008;7:93–106
  26. Lew KH, Chang EY, Rajagopalan K, Knoth RL. The effect of medication adherence on health care utilization in bipolar disorder. Manag. Care Interface. 2006;19:41–46
  27. Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, et al. for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N. Engl. J. Med. 2005;353:1209–1223
  28. Lindenmayer JP, Czobor P, Alphs L, Nathan AM, Anand R, Islam Z, et al. The InterSePT scale for suicidal thinking reliability and validity. Schizophr. Res. 2003;63:161–170
  29. Martinez-Aran A, Vieta E, Chengappa KN, Gershon S, Mullen J, Paulsson B. Reporting outcomes in clinical trials for bipolar disorder: a commentary and suggestions for change. Bipolar Disord. 2008;10:566–579
  30. McIntyre RS, Mancini DA, Lin P, Jordan J. Treating bipolar disorder. Evidence-based guidelines for family medicine. Can. Fam. Physician. 2004;50:388–394
  31. McIntyre RS, Brecher M, Paulsson B, Huizar K, Mullen J. Quetiapine or haloperidol as monotherapy for bipolar mania: a 12-week, double-blind, randomised, parallel-group, placebo-controlled trial. Eur. Neuropsychopharmacol. 2005;15:573–585
  32. McIntyre RS, Muzina DJ, Kemp DE, Blank D, Woldeyohannes HO, Lofchy J, et al. Bipolar disorder and suicide: research synthesis and clinical translation. Curr. Psychiatry Rep. 2008;10:66–72
  33. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord. 2009;11:673–686
  34. McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009;11:815–826
  35. McKendrick J, Cerri KH, Lloyd A, D'Ausilio A, Dando S, Chinn C. Cost effectiveness of olanzapine in prevention of affective episodes in bipolar disorder in the United Kingdom. J. Psychopharmacol. 2007;21:588–596
  36. Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch. Gen. Psychiatry. 2007;64:543–552
  37. Montgomery SM. Depressive symptoms in acute schizophrenia. Prog. Neuropsychopharmacol. 1979;3:429–433
  38. Newcomer JW. Metabolic risk during antipsychotic treatment. Clin. Ther. 2004;26:1936–1946
  39. Osby U, Brandt L, Correia N, Ekbom A, Sparen P. Excess mortality in bipolar and unipolar disorder in Sweden. Arch. Gen. Psychiatry. 2001;58:844–850
  40. Peeters PAM, Bockbrader H, Spaans E, Lasseter K, Marbury T, Gibson PJ, et al. Asenapine pharmacokinetics: influence of hepatic and renal impairment. In: Presented at: American Psychiatric Association; May 3–8, 2008; Washington, DC. 2008;
  41. Perlis RH, Welge JA, Vornik LA, Hirschfeld RM, Keck PE. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J. Clin. Psychiatry. 2006;67:509–516
  42. Perlis RH, Baker RW, Zarate CA, Brown EB, Schuh LM, Jamal HH, et al. Olanzapine versus risperidone in the treatment of manic or mixed states in bipolar I disorder: a randomized, double-blind trial. J. Clin. Psychiatry. 2006;67:1747–1753
  43. Potkin SG, Keck PE, Segal S, Ice K, English P. Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. J. Clin. Psychopharmacol. 2005;25:301–310
  44. Potkin SG, Cohen M, Panagides J. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. J. Clin. Psychiatry. 2007;68:1492–1500
  45. Sachs G, Sanchez R, Marcus R, Stock E, McQuade R, Carson W, et al. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study. J. Psychopharmacol. 2006;20:536–546
  46. Saphris® (asenapine). Full Prescribing Information. Kenilworth, NJ: Merck; 2009;
  47. Shahid M, Walker G, Zorn S, Wong E. Asenapine: a novel psychopharmacologic agent with a unique human receptor signature. J. Psychopharmacol. 2009;23:65–73
  48. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J. Clin. Psychiatry. 1998;59(Suppl 20):22–33quiz 34–57
  49. Simons WR, Krishnan AA. The economic value of lamotrigine as a mood stabilizer: a U.S. managed care perspective. Manag. Care Interface. 2004;17:44–49
  50. Stensland MD, Jacobson JG, Nyhuis A. Service utilization and associated direct costs for bipolar disorder in 2004: an analysis in managed care. J. Affect. Disord. 2007;101:187–193
  51. Suppes T, McElroy SL, Hirschfeld R. Awareness of metabolic concerns and perceived impact of pharmacotherapy in patients with bipolar disorder: a survey of 500 US psychiatrists. Psychopharmacol. Bull. 2007;40:22–37quiz 38–40
  52. Tohen M, Sanger TM, McElroy SL, Tollefson GD, Chengappa KN, Daniel DG, et al. Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am. J. Psychiatry. 1999;156:702–709
  53. Tohen M, Jacobs TG, Grundy SL, McElroy SL, Banov MC, Janicak PG, et al. Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. The Olanzapine HGGW Study Group. Arch. Gen. Psychiatry. 2000;57:841–849
  54. Tondo L, Isacsson G, Baldessarini R. Suicidal behaviour in bipolar disorder: risk and prevention. CNS Drugs. 2003;17:491–511
  55. Vieta E, Sanchez-Moreno J. Acute and long-term treatment of mania. Dialogues Clin. Neurosci. 2008;10:165–179
  56. Wolfsperger M, Greil W, Rossler W, Grohmann R. Pharmacological treatment of acute mania in psychiatric in-patients between 1994 and 2004. J. Affect. Disord. 2007;99:9–17
  57. Yatham LN, Kennedy SH, O'Donovan C, Parikh S, MacQueen G, McIntyre R, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: consensus and controversies. Bipolar Disord. 2005;7(suppl 3):5–69
  58. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br. J. Psychiatry. 1978;133:429–435

PII: S0165-0327(10)00007-8

doi: 10.1016/j.jad.2009.12.028

Journal of Affective Disorders
Volume 122, Issue 1 , Pages 27-38 , April 2010