Quetiapine extended release for the treatment of bipolar disorder

Expert Review of Neurotherapeutics

Volumn 14, Issue 9, 2014, Pages 987-1005

  Samalin, Ludovic ^a   Tremey, Aurore ^a   Llorca, Pierre Michel ^a  

^a UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

Author keywords

bipolar disorder; depression; extended release; immediate release; mania; number need to harm; number need to treat; quetiapine; second generation antipsychotic

Indexed keywords

QUETIAPINE; DIBENZOTHIAZEPINE DERIVATIVE; NEUROLEPTIC AGENT;

ANXIETY DISORDER; BIPOLAR DISORDER; BIPOLAR MANIA; COMORBIDITY; DEPRESSION; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; EXTRAPYRAMIDAL SYMPTOM; HUMAN; METABOLIC DISORDER; MOOD DISORDER; REVIEW; SOMNOLENCE; XEROSTOMIA; DRUG DELIVERY SYSTEM; FACTUAL DATABASE; STATISTICS AND NUMERICAL DATA;

ANTIPSYCHOTIC AGENTS; BIPOLAR DISORDER; DATABASES, FACTUAL; DIBENZOTHIAZEPINES; DRUG DELIVERY SYSTEMS; HUMANS;

EID: 84906718499     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.2014.946407     Document Type: Review

References (80)

1. Elgie R, Morselli PL. Social functioning in bipolar patients: the perception and perspective of patients, relatives and advocacy organizations -a review. Bipolar Disord 2007;9(1-2):144-57
2. Judd LL, Akiskal HS. The prevalence and disability of bipolar spectrum disorders in the US population: re-analysis of the ECA database taking into account subthreshold cases. J Affect Disord 2003; 73(1-2):123-31
3. Pini S, de Queiroz V, Pagnin D, et al. Prevalence and burden of bipolar disorders in European countries. Eur Neuropsychopharmacol 2005;15(4):425-34
4. Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: global Burden of Disease Study. Lancet 1997;349(9063):1436-42
5. Frye MA, Ha K, Kanba S, et al. International consensus group on depression prevention in bipolar disorder. J Clin Psychiatry 2011;72(10):1295-310
6. Goodwin GM. Evidence-based guidelines for treating bipolar disorder: revised second edition-recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2009;23(4):346-88
7. 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(2):85-116
8. 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 2010 on the treatment of acute bipolar depression. World J Biol Psychiatry 2010;11(2):81-109
9. 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 2012 on the long-term treatment of bipolar disorder. World J Biol Psychiatry 2013;14(3):154-219
10. Llorca PM, Courtet P, Martin P, et al. Screening and management of bipolar disorders: results. Encephale 2010; 36(Suppl 4):S86-102
11. Malhi GS, Adams D, Lampe L, et al. Clinical practice recommendations for bipolar disorder. Acta Psychiatr Scand Suppl 2009;(439):27-46
12. Yatham LN, Kennedy SH, Parikh SV, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013. Bipolar Disord 2013;15(1):1-44
13. Calabrese JR, Kasper S, Johnson G, et al. International consensus group on bipolar i depression treatment guidelines. J Clin Psychiatry 2004;65(4):571-9
14. Samalin L, Guillaume S, Courtet P, et al. Methodological differences between pharmacological treatment guidelines for bipolar disorder: what to do for the clinicians? Compr Psychiatry 2013;54(4): 309-20
15. El-Khalili N. Update on extended release quetiapine fumarate in schizophrenia and bipolar disorders. Neuropsychiatr Dis Treat 2012;8:523-36
16. Sanford M, Keating GM. Quetiapine: a review of its use in the management of bipolar depression. CNS Drugs 2012;26(5): 435-60
17. AstraZeneca. Seroquel (quetiapine fumarate) tablets: highlights of prescribing information. 2011. Available from: www.accessdata.fda.gov/ drugsatfda-docs/label/2011/020639s049s054lbl.pdf
18. AstraZeneca. Seroquel (quetiapine): summary of product characteristics. 2012. Available from: www.medicines.org.uk/emc/medicine/2295
19. Bowden CL, Grunze H, Mullen J, et al. A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 2005;66(1):111-21
20. McIntyre RS, Brecher M, Paulsson B, et al. Quetiapine or haloperidol as monotherapy for bipolar mania -a 12-week, double-blind, randomized, parallel-group, placebo-controlled trial. Eur Neuropsychopharmacol 2005;15(5):573-85
21. Vieta E, Mullen J, Brecher M, et al. Quetiapine monotherapy for mania associated with bipolar disorder: combined analysis of two international, double-blind, randomized, placebo-controlled studies. Curr Med Res Opin 2005;21(6):923-34
22. Pathak S, Findling RL, Earley WR, et al. Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial. J Clin Psychiatry 2013;74(1):100-9
23. Sachs G, Chengappa KN, Suppes T, et al. Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study. Bipolar Disord 2004;6(3):213-23
24. Yatham LN, Vieta E, Young AH, et al. A double blind, randomized, placebo-controlled trial of quetiapine as an add-on therapy to lithium or divalproex for the treatment of bipolar mania. Int Clin Psychopharmacol 2007;22(4):212-20
25. Yatham LN, Paulsson B, Mullen J, Vågerö M. Quetiapine versus placebo in combination with lithium or divalproex for the treatment of bipolar mania. J Clin Psychopharmacol 2004;24(6):599-606
26. Calabrese JR, Keck PE Jr, Macfadden W, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162(7):1351-60
27. Thase ME, Macfadden W, Weisler RH, et al. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 2006;26(6): 600-9
28. Young AH, McElroy SL, Bauer M, et al. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry 2010;71(2):150-62
29. McElroy SL, Weisler RH, Chang W, et al. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry 2010; 71(2):163-74
30. Vieta E, Suppes T, Eggens I, et al. Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126). J Affect Disord 2008;109(3):251-63
31. Suppes T, Vieta E, Liu S, et al. Maintenance treatment for patients with bipolar I disorder: results from a North American study of quetiapine in combination with lithium or divalproex (trial 127). Am J Psychiatry 2009;166(4): 476-88
32. Ketter TA, Citrome L, Wang PW, et al. Treatments for bipolar disorder: can number needed to treat/harm help inform clinical decisions? Acta Psychiatr Scand 2011;123(3):175-89
33. Citrome L, Ketter TA. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Int J Clin Pract 2013;67(5):407-11
34. Citrome L, Ketter TA, Cucchiaro J, Loebel A. Clinical assessment of lurasidone benefit and risk in the treatment of bipolar I depression using number needed to treat, number needed to harm, and likelihood to be helped or harmed. J Affect Disord 2014;155:20-7
35. Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf 2009;4(3):229-37
36. AstraZeneca. Seroquel XR (quetiapine fumarate) extended-release tablets : highlights of prescribing information. 2009. Available from: www.accessdata.fda.gov/drugsatfda-docs/label/2009/022047s011s016s017s019s022lbl. pdf
37. AstraZeneca. Seroquel XL (quetiapine) prolonged-release tablets: summary of product characteristics. 2012. Available from: www.medicines.org.uk/emc/ medicine/21175/SPC/Seroquel+XL+50+mg%2c +150mg%2c+200+mg%2c+300+mg%2c +400+mg+prolonged-release+tablets/
38. Bui K, Earley W, Nyberg S. Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications. Curr Med Res Opin 2013; 29(7):813-25
39. Figueroa C, Brecher M, Hamer-Maansson JE, Winter H. Pharmacokinetic profiles of extended release quetiapine fumarate compared with quetiapine immediate release. Prog Neuropsychopharmacol Biol Psychiatry 2009;33(2):199-204
40. Goldstein J, Christoph G, Grimm S, et al. Quetiapine's antidepressant properties: direct and indirect pharmacologic actions on norepinephrine and serotonin receptors. Eur Neuropsychopharmacol 2007;17(Suppl 4): S401
41. Nyberg S, Jucaite A, Takano A, et al. Norepinephrine transporter occupancy in the human brain after oral administration of quetiapine XR. Int J Neuropsychopharmacol 2013;16(10): 2235-44
42. Bjorkholm C, Jardemark K, Marcus MM, et al. Role of concomitant inhibition of the norepinephrine transporter for the antipsychotic effect of quetiapine. Eur Neuropsychopharmacol 2013;23(7):709-20
43. Jensen NH, Rodriguiz RM, Caron MG, et al. N-desalkylquetiapine, a potent norepinephrine re-uptake inhibitor and partial 5-HT1A agonist, as a putative mediator of quetiapine's antidepressant activity. Neuropsychopharmacology 2008; 33(10):2303-12
44. Mamo DC, Uchida H, Vitcu I, et al. Quetiapine extended-release versus immediate-release formulation: a positron emission tomography study. J Clin Psychiatry 2008;69(1):81-6
45. Nord M, Nyberg S, Brogren J, et al. 2) dopamine receptor occupancy after oral administration of quetiapine fumarate immediate-release and extended-release formulations in healthy subjects. Int J Neuropsychopharmacol 2011;14(10): 1357-66
46. Cutler AJ, Datto C, Nordenhem A, et al. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther 2011;33(11):1643-58
47. Dell'Osso B, Arici C, Dobrea C, et al. Efficacy, tolerability, compliance, and quality of life of patients with mood disorders switched from quetiapine immediate release to extended release. Int Clin Psychopharmacol 2012;27(6):310-13
48. Sheehan DV, Harnett-Sheehan K, Hidalgo RB, et al. Randomized, placebo-controlled trial of quetiapine XR and divalproex ER monotherapies in the treatment of the anxious bipolar patient. J Affect Disord 2013;145(1):83-94
49. Suppes T, Datto C, Minkwitz M, et al. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord 2010;121(1-2): 106-15
50. AstraZeneca. NCT00521365 : effectiveness of quetiapine XR on the control of symptoms of manic phase of bipolar disorder (EMMY). 2012. Available from: www.clinicaltrials.gov/ct2/show/NCT00521365
51. AstraZeneca. NCT00931723 : adult bipolar mania. 2012. Available from: www.clinicaltrials.gov/ct2/show/NCT00931723
52. AstraZeneca. NCT00811473 : pediatric bipolar depression. 2012. Available from: www.clinicaltrials.gov/ct2/show/NCT00811473
53. Alfaro C. An 8-week, multicenter, double-blind, randomized, parallel-group, placebo-controlled study of the efficacy and safety of quetiapine fumarate (Seroquel XR) extended-release in children and adolescent subjects with bipolar depression: clinical review. 2013. Available from: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ UCM358780.pdf
54. AstraZeneca. NCT00883493 : efficacy and safety of quetiapine versus quetiapine plus lithium in bipolar depression (QUALITY). 2012. Available from: www.clinicaltrials.gov/ct2/show/NCT00883493
55. AstraZeneca. NCT00857584: quetiapine XR versus sertraline in acute bipolar depression as add-on therapy. 2012. Available from: www.clinicaltrials. gov/ct2/show/NCT00857584
56. Gao K. NCT00671853 : quetiapine extended release (XR) in bipolar patients with comorbid generalized anxiety disorder (GAD). 2013. Available from: www.clinicaltrials.gov/ct2/show/NCT00671853
57. DelBello MP, Chang K, Welge JA, et al. A double-blind, placebo-controlled pilot study of quetiapine for depressed adolescents with bipolar disorder. Bipolar Disord 2009; 11(5):483-93
58. Weisler RH, Calabrese JR, Thase ME, et al. Efficacy of quetiapine monotherapy for the treatment of depressive episodes in bipolar I disorder: a post hoc analysis of combined results from 2 double-blind, randomized, placebo-controlled studies. J Clin Psychiatry 2008;69(5):769-82
59. Suppes T, Hirschfeld RM, Vieta E, et al. Quetiapine for the treatment of bipolar II depression: analysis of data from two randomized, double-blind, placebo-controlled studies. World J Biol Psychiatry 2008;9(3):198-211
60. Young AH, Calabrese JR, Gustafsson U, et al. Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies. Int J Bipolar Disord 2013;1(1):1-12
61. Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther 2009; 31(3):492-502
62. Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther 2012;34(11): 2202-11
63. Meulien D, Huizar K, Brecher M. Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomized, double-blind, placebo-controlled studies. Hum Psychopharmacol 2010;25(2):103-15
64. Peuskens J, Trivedi J, Malyarov S, et al. Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients. Psychiatry (Edgmont) 2007;4(11):34-50
65. Wang Z, Kemp DE, Chan PK, et al. Comparisons of the tolerability and sensitivity of quetiapine-XR in the acute treatment of schizophrenia, bipolar mania, bipolar depression, major depressive disorder, and generalized anxiety disorder. Int J Neuropsychopharmacol 2011;14(1): 131-42
66. Peuskens J. The management of schizophrenia: focus on extended-release quetiapine fumarate. Neuropsychiatr Dis Treat 2011;7:549-64
67. Lang K, Korn J, Muser E, et al. Predictors of medication nonadherence and hospitalization in Medicaid patients with bipolar I disorder given long-acting or oral antipsychotics. J Med Econ 2011;14(2): 217-26
68. Gao K, Kemp DE, Fein E, et al. Number needed to treat to harm for discontinuation due to adverse events in the treatment of bipolar depression, major depressive disorder, and generalized anxiety disorder with atypical antipsychotics. J Clin Psychiatry 2011;72(8):1063-71
69. Cramer JA, Mattson RH, Prevey ML, et al. How often is medication taken as prescribed? A novel assessment technique. JAMA 1989;261(22):3273-7
70. Gutierrez-Rojas L, Jurado D, Martinez-Ortega JM, Gurpegui M. Poor adherence to treatment associated with a high recurrence in a bipolar disorder outpatient sample. J Affect Disord 2010; 127(1-3):77-83
71. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23(8): 1296-310
72. Leucht S, Komossa K, Rummel-Kluge C, et al. A meta-analysis of head-to-head comparisons of second-generation antipsychotics in the treatment of schizophrenia. Am J Psychiatry 2009; 166(2):152-63
73. Rummel-Kluge C, Komossa K, Schwarz S, et al. Head-to-head comparisons of metabolic side effects of second generation antipsychotics in the treatment of schizophrenia: a systematic review and meta-analysis. Schizophr Res 2010;123(2-3): 225-33
74. Wang M, Tong JH, Huang DS, et al. Efficacy of olanzapine monotherapy for treatment of bipolar I depression: a randomized, double-blind, placebo controlled study. Psychopharmacology (Berl) 2014;231(14):2811-18
75. Tohen M, Katagiri H, Fujikoshi S, Kanba S. Efficacy of olanzapine monotherapy in acute bipolar depression: a pooled analysis of controlled studies. J Affect Disord 2013; 149(1-3):196-201
76. Cerullo MA, Strakowski SM. A systematic review of the evidence for the treatment of acute depression in bipolar I disorder. CNS Spectr 2013;18(4):199-208
77. Geddes JR, Calabrese JR, Goodwin GM. Lamotrigine for treatment of bipolar depression: independent meta-analysis and meta-regression of individual patient data from five randomized trials. Br J Psychiatry 2009;194(1):4-9
78. Bond DJ, Lam RW, Yatham LN. Divalproex sodium versus placebo in the treatment of acute bipolar depression: a systematic review and meta-analysis. J affect disord 2010;124:228-34
79. Geoffroy PA, Bellivier F, Leboyer M, Etain B. Can the response to mood stabilizers be predicted in bipolar disorder? Front Biosci (Elite Ed) 2014;6:120-38
80. Murphy E, McMahon FJ. Pharmacogenetics of antidepressants, mood stabilizers, and antipsychotics in diverse human populations. Discov Med 2013;16(87): 113-22