Evaluating aripiprazole as a potential bipolar disorder therapy for adults

Expert Opinion on Investigational Drugs

Volumn 23, Issue 12, 2014, Pages 1713-1730

  Moro, Maria Francesca ^a   Carta, Mauro Giovanni ^a  

^a UNIVERSITY OF CAGLIARI   (Italy)

Author keywords

Aripiprazole; Bipolar depression; Bipolar disorder; Mania; Mixed episode

Indexed keywords

ARIPIPRAZOLE; NEUROLEPTIC AGENT; PIPERAZINE DERIVATIVE; QUINOLONE DERIVATIVE;

AGITATION; AKATHISIA; ANXIETY DISORDER; ASTHENIA; BIPOLAR DEPRESSION; BIPOLAR DISORDER; COMORBIDITY; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MARKETING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EXTRAPYRAMIDAL SYMPTOM; HUMAN; INSOMNIA; MAINTENANCE THERAPY; MANIA; META ANALYSIS; MIXED MANIA AND DEPRESSION; MONOTHERAPY; NAUSEA; RELAPSE; REVIEW; SYSTEMATIC REVIEW; TREMOR; VOMITING; YOUNG MANIA RATING SCALE; ADULT; ANIMAL; METABOLISM; TREATMENT OUTCOME;

ADULT; ANIMALS; ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; HUMANS; PIPERAZINES; QUINOLONES; TREATMENT OUTCOME;

EID: 84924348855     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2014.971152     Document Type: Review

References (62)

1. Fajutrao L, Locklear J, Priaulx J, Heyes A. A systematic review of the evidence of the burden of bipolar disorder in Europe. Clin Pract Epidemiol Ment Health 2009;5:3
2. Merikangas KR, Jin R, He JP, et al. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry 2011;68:241-51
3. Kleine-Budde K, Touil E, Moock J, et al. Cost of illness for bipolar disorder: a systematic review of the economic burden. Bipolar Disord 2014;16(4):337-53
4. Dardennes R, Thuile J, Friedman S, Guelfi JD. The costs of bipolar disorder. Encephale 2006;32(1 Pt 1):18-25
5. Grunze H, Vieta E, Goodwin GM, et al. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2009 on the treatment of acute mania. World J Biol Psychiatry 2009;10:85-1167
6. Tohen M, Vieta E, Calabrese J, et al. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003;60(11):1079-88; Erratum in: Arch Gen Psychiatry. 2004;6:176
7. Thase ME, Macfadden W, Weisler RH, et al. Efficacy of quetiapine monotherapy in bipolar I and II depression: a doubleblind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 2006;26(6):600-9; Erratum in: J Clin Psychopharmacol. 2007;27:51
8. Fountoulakis KN, Vieta E, Schmidt F. Aripiprazole monotherapy in the treatment of bipolar disorder: a meta-analysis. J Affect Disord 2011;133:361-70
9. EMA. European Medicines Agency. Doc Ref 553684/2009 EMEA/H/C/71, 2009 (rev 2013)
10. Ketter TA. Nosology, diagnostic challenges, and unmet needs in managing bipolar disorder. J Clin Psychiatry 2010;71:e27
11. Davies MA, Conley Y, Roth BL. Functional SNPs in genes encoding the 5-HT2A receptor modify the affinity and potency of several atypical antipsychotic drugs. Biol Res Nurs 2011;13(1):55-60
12. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:1209-23
13. Mantere O, Isometsa E, Ketokivi M, et al. A prospective latent analyses study of psychiatric comorbidity of DSM-IV bipolar I and II disorders. Bipolar Disord 2010;12:271-84
14. Newcomer JW. Medical risk in patients with bipolar disorder and schizophrenia. J Clin Psychiatry 2006;67:e16
15. Zhang J, Kowal D, Nawoschik S, et al. Distinct functional profiles of aripiprazole and olanzapine at RNA edited human 5-HTreceptor isoforms. Biochem Pharmacol 2006;71:521-9
16. Shapiro DA, Renock S, Arrington E, et al. Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacology 2003;28:1400-11
17. Burda K, Czubak A, Kus K, et al. Influence of aripiprazole on the antidepressant,anxiolytic and cognitive functions of rats. Pharmacol Rep 2011;63:898-907
18. Greenaway M, Elbe D. Focus on aripiprazole: a review of its use in child and adolescent psychiatry. J Can Acad Child Adolesc Psychiatry 2009;18:250-60
19. Shopsin B, Gershon S. Dopamine receptor stimulation in the treatment of depression: piribedil (ET-495). Neuropsychobiology 1978;4:1-14
20. Yoneyama M, Hasebe S, Kawamoto N, et al. Beneficial in vivo effect of aripiprazole on neuronal regeneration following neuronal loss in the dentate gyrus: evaluation using a mouse model of trimethyltin-induced neuronal loss/self-repair in the dentate gyrus. J Pharmacol Sci 2014;124:99-111
21. Mavrikaki M, Schintu N, Kastellakis A, et al. Effects of lithium and aripiprazole on brain stimulation reward and neuroplasticity markers in the limbic forebrain. Eur Neuropsychopharmacol 2014;24:630-8
22. Higgins J, Green S. editors. Cochrane handbook for systematic reviews of interventions version 5.0.2. [updated September 2009] The Cochrane Collaboration, 2009. Available from: www.cochrane-handbook.org
23. Kanba S, Kawasaki H, Ishigooka J, et al. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study). World J Biol Psychiatry 2014;15(2):113-21
24. El Mallakh RS, Vieta E, Rollin L, et al. A comparison of two fixed doses of aripiprazole with placebo in acutely relapsed, hospitalized patients with bipolar disorder I (manic or mixed) in subpopulations (CN138-007). Eur Neuropsychopharmacol 2010;20:776-83
25. Keck PE, Orsulak PJ, Cutler AJ, et al. CN138-135 Study Group Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, doubleblind, placebo- and lithium-controlled study. J Affect Disord 2009;112(1-3):36-49
26. Young AH, Oren DA, Lowy A, et al. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry 2009;194(1):40-8
27. Sachs GS, Gaulin BD, Gutierrez-Esteinou R, et al. Antimanic response to aripiprazole in bipolar I disorder patients is independent of the agitation level at baseline. J Clin Psychiatry 2007;68:1377-83
28. Keck PE Jr, Marcus R, Tourkodimitris S, et al. Aripiprazole Study Group. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 2003;160(9):1651-8
29. Vieta E, Bourin M, Sanchez R, et al. Aripiprazole Study Group. Effectiveness of aripiprazole v. haloperidol in acute bipolar mania: double-blind, randomised, comparative 12-week trial. Br J Psychiatry 2005;187:235-42
30. Jeong HG, Lee MS, Lee HY, et al. Changes in sexual function and gonadal axis hormones after switching to aripiprazole in male schizophrenia patients: a prospective pilot study. Int Clin Psychopharmacol 2012;27:177-83
31. Vieta E, Tohen C, McQuade RD, et al. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry 2008;165:1316-25
32. NCT00665366. Available from: http:// clinicaltrials.gov/show/NCT00665366
33. 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(2):171-6
34. Thase ME, Jonas A, Khan A, et al. Aripiprazole monotherapy in nonpsychotic bipolar I depression: results of 2 randomized, placebo-controlled studies. J Clin Psychopharmacol 2008;28(1):13-20
35. Quante A, Zeugmann S, Luborzewski A, et al. Aripiprazole as adjunct to a mood stabilizer and citalopram in bipolar depression: a randomized placebo-controlled pilot study. Hum Psychopharmacol 2010;25:126-32
36. Keck PE Jr, Calabrese JR, McQuade RD, Aripiprazole Study Group. A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psychiatry 2006;67(4):626-37
37. Keck PE Jr, Calabrese JR, McIntyre RS, et al. Aripiprazole Study Group. Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: a 100-week, double-blind study versus placebo. J Clin Psychiatry 2007;68(10):1480-91
38. El-Mallakh RS, Marcus R, Baudelet C, et al. A 40-week double-blind aripiprazole versus lithium follow-up of a 12-week acute phase study (total 52 weeks) in bipolar I disorder. J Affect Disord 2012;136:258-66
39. Carlson BX, Ketter TA, Sun W, et al. Aripiprazole in combination with lamotrigine for the long-term treatment of patients with bipolar I disorder (manic or mixed): a randomized, multicenter, double-blind study (CN138-392). Bipolar Disord 2012;14(1):41-53
40. Woo YS, Bahk WM, Chung MY, et al. Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial. Hum Psychopharmacol 2011;26(8):543-53
41. Marcus R, Khan A, Rollin L, et al. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord 2011;13(2):133-44
42. Vieta E, Owen R, Baudelet C, et al. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46- week, open-label extension following a 6- week double-blind study. Curr Med Res Opin 2010;26(6):1485-96
43. Cipriani A, Rendell JM, Geddes JR. Haloperidol alone or in combination for acute mania. Cochrane Database Syst Rev 2006;3:CD004362
44. Perlis RH, Welge JA, Vornik LA, et al. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006;67:509-16
45. Scherk H, Pajonk FG, Leucht S. Second-generation antipsychotic agents in the treatment of acute mania: a systematic review and meta-analysis of randomized controlled trials. Arch Gen Psychiatry 2007;64:442-55
46. Smith LA, Cornelius V, Warnock A, et al. Pharmacological interventions for acute bipolar mania: a systematic review of randomized placebo-controlled trials. Bipolar Disord 2007;9:551-60
47. Sachs GS, Gaulin BD, Gutierrez-Esteinou R, et al. Antimanic response to aripiprazole in bipolar I disorder patients is independent of the agitation level at baseline. J Clin Psychiatry 2007;68:1377-83
48. Fountoulakis KN, Gonda X, Vieta E, Schmidt F. Treatment of psychotic symptoms in bipolar disorder with aripiprazole monotherapy: a meta-analysis. Ann Gen Psychiatry 2009;8:27
49. Yildiz A, Vieta E, Leucht S, Baldessarini RJ. Efficacy of anti- manic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 2011;36:375-89
50. Cipriani A, Barbui C, Salanti G, et al. Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet 2011;378:1306-15
51. Kasteng F, Eriksson J, Sennfalt K, et al. Metabolic effects and cost-effectiveness of aripiprazole versus olanzapine in schizophrenia and bipolar disorder. Acta Psychiatr Scand 2011;124:214-25
52. Goikolea JM, Colom F, Torres I, et al. Lower rate of depressives witch following antimanic treatment with second-generation antipsychotics versus haloperidol. J Affect Disord 2013a;144:91-198
53. Goikolea JM, Colom F, Capapey J, et al. Faster onset of antimanic action with haloperidol Compared to second-generation antipsychotics. A meta-analysis of randomized clinical trials in acute mania. Eur Neuropsychopharmacol 2013b;23:305-16
54. Kemp DE, DeHert M, Rahman Z, et al. Investigation in to the long-term metabolic effects of aripiprazole adjunctive to lithium, valproate, or lamotrigine. J Affect Disord 2013;148:84-91
55. Brown R, Taylor MJ, Geddes J. Aripiprazole alone or in combination for acute mania. Cochrane Database Syst Rev 2013;12:CD005000. Review
56. Bachmann CJ, Rieger-Gies A, Heinzel-Gutenbrunner M, et al. Large variability of aripiprazole and dehydroaripiprazole serum concentrations in adolescent patients with schizophrenia. Ther Drug Monit 2008;30(4):462-6
57. Lin SK, Chen CK, Liu YL. Aripiprazole and dehydroaripiprazole plasma concentrations and clinical responses in patients with schizophrenia. J Clin Psychopharmacol 2011;31(6):758-62
58. Suzuki T, Mihara K, Nakamura A, et al. Effects of the CYP2D6∗10 allele on the steady-state plasma concentrations of aripiprazole and its active metabolite, dehydroaripiprazole, in Japanese patients with schizophrenia. Ther Drug Monit 2011;33(1):21-4
59. Sistonen J, Sajantila A, Lao O, et al. CYP2D6 worldwide genetic variation shows high frequency of altered activity variants and no continental structure. Pharmacogenet Genomics 2007;17(2):93-101
60. Sparshatt A, Taylor D, Patel MX, Kapur S. A systematic review of aripiprazole-dose, plasma concentration, receptor occupancy, and response: implications for therapeutic drug monitoring. J Clin Psychiatry 2010;71(11):1447-56
61. Jon D, Kim do H, Seo HJ, et al. Augmentation of aripiprazole for depressed patients with an inadequate response to antidepressant treatment: a 6- week prospective, open-label, multicenter study. Clin Neuropharmacol 2013;36(5):157-61
62. Pae CU, Jeon HJ, Lee BC, et al. Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study. Int Clin Psychopharmacol 2013;28(6):322-9