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Lurasidone: A Review of Its Use in Adult Patients with Bipolar I Depression

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Abstract

Lurasidone (Latuda®), a benzisothiazole derivative antipsychotic, is approved in the USA and Canada for the treatment of adults with major depressive episodes (MDE) associated with bipolar I disorder; this article reviews studies of lurasidone in this indication. In two 6-week, placebo-controlled trials in adults with bipolar I depression, lurasidone 20–120 mg/day reduced depressive symptoms, either as monotherapy or as an adjunct to lithium or valproate. Lurasidone reduced the mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score from baseline (primary endpoint) by >50 %; the reductions in scores were significantly greater than with placebo. The treatment effects were small to medium and the numbers needed to treat to obtain an additional MDE response (≥50 % reduction from baseline in the MADRS total score) were ≤7 across the lurasidone groups. In a third, similarly designed trial of lurasidone 20–120 mg/day adjunctive to lithium or valproate, there was no significant between-group difference in the change in the mean MADRS total score at week 6 (primary endpoint), although significant differences favouring lurasidone were observed from week 2 to week 5. Across trials, the most frequently occurring adverse events included akathisia, extrapyramidal symptoms and somnolence. Lurasidone had a favourable profile with respect to weight gain and metabolic disturbances, known to occur with some other antipsychotics. Thus, lurasidone offers a valuable addition to the therapies available for adult patients with bipolar depression, either as monotherapy or as an adjunct to lithium or valproate.

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References

  1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: Am Psychiatr Assoc; 2000.

    Google Scholar 

  2. Judd LL, Akiskal HS, Schettler PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002;59(6):530–7.

    Article  PubMed  Google Scholar 

  3. Ösby U, Brandt L, Correia N, et al. Excess mortality in bipolar and unipolar disorder in Sweden. Arch Gen Psychiatry. 2001;58(9):844–50.

    Article  PubMed  Google Scholar 

  4. Vieta E, Valenti M. Pharmacological management of bipolar depression: acute treatment, maintenance, and prophylaxis. CNS Drugs. 2013;27(7):515–29.

    Article  CAS  PubMed  Google Scholar 

  5. Sanford M. Lurasidone: in the treatment of schizophrenia. CNS Drugs. 2013;27(1):67–80.

    Article  CAS  PubMed  Google Scholar 

  6. European Medicines Agency. Latuda: summary of product characteristics. http://www.ema.europa.eu. Accessed 11 Feb 2015.

  7. Sunovion. Latuda (lurasidone HCl) tablets: US prescribing information. 2013. http://www.latuda.com. Accessed 11 Feb 2015.

  8. Sunovion Pharmaceuticals Canada Inc. Latuda (lurasidone hydrochloride): Canadian product monograph. 2014. http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp. Accessed 11 Feb 2015.

  9. Ishibashi T, Horisawa T, Tokuda K, et al. Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity. J Pharmacol Exp Ther. 2010;334(1):171–81.

    Article  CAS  PubMed  Google Scholar 

  10. Álamo C, López-Muñoz F, García-García P. The effectiveness of lurasidone as an adjunct to lithium or divalproex in the treatment of bipolar disorder. Expert Rev Neurother. 2014;14(6):593–605.

    Article  PubMed  Google Scholar 

  11. Chiu Y-Y, Ereshefsky L, Preskorn SH, et al. Lurasidone drug–drug interaction studies: a comprehensive review. Drug Metab Drug Interact. 2014;29(3):191–202.

    Article  CAS  Google Scholar 

  12. Loebel A, Cucchiaro J, Silva R, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171(2):169–77.

    Article  PubMed  Google Scholar 

  13. Loebel A, Cucchiaro J, Silva R, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171(2):160–8.

    Article  PubMed  Google Scholar 

  14. Suppes T, Calabrese J, Silva R, et al. Lurasidone adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study (PREVAIL 3) [abstract no. W147 plus poster]. Neuropsychopharmacology. 2013;38(Suppl 2s).

  15. Ketter TA, Sarma K, Silva R, et al. Lurasidone in bipolar I depression: a 24-week, open-label extension study [abstract no. 17 plus poster]. In: Annual Meeting of the American Society of Clinical Psychopharmacology; 2014.

  16. Iosifescu DV, Pikalov A, Kroger H, et al. Early sustained response with lurasidone in the treatment of bipolar I depression [abstract no. NR6-053 plus poster]. In: 167th Annual Meeting of the American Psychiatric Association; 2014.

  17. Thase ME, Tsai J, Kroger H, et al. Lurasidone treatment for bipolar I depression: effect on core depressive symptoms [abstract no. P-41-009 plus poster]. In: 29th International College of Neuropsychopharmacology World Congress; 2014.

  18. Calabrese JR, Ketter TA, Kando J, et al. A post hoc analysis of efficacy and tolerability of lurasidone adjunctive therapy with either lithium or valproate for the treatment of bipolar I depression [abstract no. 92 plus poster]. In: College of Psychiatric and Neurologic Pharmacists Annual Meeting; 2014.

  19. McIntyre R, Allen M, Cucchiaro J, et al. Lurasidone for the treatment of bipolar I depression: treatment outcomes in the presence of subsyndromal hypomanic features [abstract plus poster]. In: 9th Annual Neuroscience Educational Institute Psychopharmacology Congress; 2013.

  20. Goldberg JF, Pikalov A, Werner P, et al. Lurasidone monotherapy of bipolar depression: influence of baseline thyroid function on treatment response [abstract no. 14 plus poster]. In: Annual Meeting of the American Society of Clinical Psychopharmacology; 2014.

  21. Chapel S, Chiu Y, Hsu J, et al. Exposure-response model of lurasidone in patients with bipolar depression [abstract no. NR6-44 plus poster]. In: 167th Annual Meeting of the American Psychiatric Association; 2014.

  22. Hirschfeld RMA, Cucchiaro J, Pikalov A, et al. Effect of lurasidone monotherapy or adjunctive therapy on anxiety symptoms in patients with bipolar I depression [abstract plus poster]. In: 10th International Conference on Bipolar Disorder; 2013.

  23. Ketter TA, Cucchiaro J, Silva R, et al. Lurasidone treatment for bipolar I depression: effects on quality of life and patient functioning [abstract no. NR6-56 plus poster]. In: 167th Annual Meeting of the American Psychiatric Association; 2014.

  24. McElroy S, Pikalov A, Cucchiaro J, et al. Short- and longer-term treatment with lurasidone in patients with bipolar I depression: effect on metabolic syndrome [abstract no. P-22-009 plus poster]. In: 29th International College of Neuropsychopharmacology World Congress; 2014.

  25. 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.

    Article  CAS  PubMed  Google Scholar 

  26. Sandlin EKL, Gao Y, El-Mallakh RS. Pharmacotherapy of bipolar disorder: current status and emerging options. Clin Pract. 2014;11(1):39–48.

    Article  CAS  Google Scholar 

  27. Wang WAD, Ansari A, Osser DN. The Psychopharmacology Algorithm Project at the Harvard South Shore Program: 2014 update on bipolar depression [abstract no. P404]. Biol Psychiatry. 2014;1:130S.

    Google Scholar 

  28. Pacchiarotti I, Bond DJ, Baldessarini RJ, et al. The International Society for Bipolar Disorders (ISBD) task force report on antidepressant use in bipolar disorders. Am J Psychiatry. 2013;170(11):1249–62.

    Article  PubMed Central  PubMed  Google Scholar 

  29. Tarsy D, Baldessarini RJ, Tarazi FI. Effects of newer antipsychotics on extrapyramidal function. CNS Drugs. 2002;16(1):23–45.

    Article  CAS  PubMed  Google Scholar 

  30. Fagiolini A, Chengappa KNR, Soreca I, et al. Bipolar disorder and the metabolic syndrome: causal factors, psychiatric outcomes and economic burden. CNS Drugs. 2008;22(8):655–69.

    Article  CAS  PubMed  Google Scholar 

  31. van Noord C, Strauss SMJM, Sturkenboom MCJM, et al. Psychotropic drugs associated with corrected QT interval prolongation. J Clin Psychopharmacol. 2009;29(1):9–15.

    Article  PubMed  Google Scholar 

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. Mark Sanford and Sohita Dhillon are salaried employees of Adis/Springer.

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    Mark Sanford & Sohita Dhillon

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  1. Mark Sanford
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  2. Sohita Dhillon
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Correspondence to Mark Sanford.

Additional information

This manuscript was reviewed by: N. K. Aggarwal, Columbia University Medical Center, New York Psychiatric Institute, New York, NY, USA; D. J. Castle, Department of Psychiatry, St Vincent’s Health and The University of Melbourne, Melbourne, Australia; P. Cowen, Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK; M. Rudorfer, Division of Services and Intervention Research, National Institute of Mental Health, Bethesda, MD, USA; T. Suzuki, Department of Neuropsychiatry, School of Medicine, Keio University, Tokyo, Japan.

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Sanford, M., Dhillon, S. Lurasidone: A Review of Its Use in Adult Patients with Bipolar I Depression. CNS Drugs 29, 253–263 (2015). https://doi.org/10.1007/s40263-015-0234-2

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