LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder

Rodolfo N Campos, Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla R L Garcia, Frederico N Demétrio, Doris H Moreno, Ricardo A Moreno, Rodolfo N Campos, Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla R L Garcia, Frederico N Demétrio, Doris H Moreno, Ricardo A Moreno

Abstract

Background: The challenge of Bipolar Disorder (BD) treatment is due to the complexity of the disease. Current guidelines represent an effort to help clinicians in their everyday practice but still have limitations, specially concerning to long term treatment. LICAVAL (efficacy and tolerability of the combination of LIthium and CArbamazepine compared to lithium and VALproic acid in the treatment of young bipolar patients) study aim to evaluate acute and maintenance phase of BD treatment with two combined drugs.

Methods: LICAVAL is a single site, parallel group, randomized, outcome assessor blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic,/hypomanic or mixed episode, aged 18 to 35 years are eligible. After the diagnostic assessments, the patients are allocated for one of the groups of treatment (lithium + valproic acid or lithium + carbamazepine). Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Outcome assessors are blind to the treatment. The main outcome is the evaluation of changes in mean scores on CGI-BP-M between baseline and endpoint at the end of each phase of the study.

Results: LICAVAL is currently in progress, with patients in phase I, II or III. It will extended until august 2012.

Conclusions: Trials comparing specific treatments efficacy in BD (head to head) can show relevant information in clinical practice. Long term treatment is an issue of great important and should be evaluated carefully in more studies as long as BD is a chronic disease.

Trial registration: ClinicalTrials.gov Identifier: NCT00976794.

References

    1. Goldberg JF. Optimizing treatment outcomes in bipolar disorder under ordinary conditions. J Clin Psychiatry. 2008;69(Suppl 3):11–9.
    1. American Psychiatric Association. Text Revision. Fourth. Washington DC, American Psychiatric Association; 2000. Diagnostic and Statistical Manual of Mental Disorders.
    1. Beyer JL. An evidence-based medicine strategy for achieving remission in bipolar disorder. J Clin Psychiatry. 2008;69(Suppl 3):31–7.
    1. Perlis RH, Ostacher MJ, Patel JK, Marangell LB, Zhang H, Wisniewski SR, Ketter TA, Miklowitz DJ, Otto MW, Gyulai L, Reilly-Harrington NA, Nierenberg AA, Sachs GS, Thase ME. Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Am J Psychiatry. 2006;163(2):217–24. doi: 10.1176/appi.ajp.163.2.217.
    1. Goodwin FK. Rationale for long-term treatment of bipolar disorder and evidence for long-term lithium treatment. J Clin Psychiatry. 2002;63(Suppl 10):5–12.
    1. Gershon S, Chengappa KN, Malhi GS. Lithium specificity in bipolar illness: a classic agent for the classic disorder. Bipolar Disord. 2009;11(Suppl 2):34–44. doi: 10.1111/j.1399-5618.2009.00709.x.
    1. Pérez-Ceballos MA, Vega-Gil N, Sánchez MB, Armijo JA. Use of antiepileptic drugs in bipolar disorder. Actas Esp Psiquiatr. 2006;34(1):55–64.
    1. Bowden CL. Anticonvulsants in bipolar disorders: current research and practice and future directions. Bipolar Disord. 2009;11(Suppl 2):20–33. doi: 10.1111/j.1399-5618.2009.00708.x.
    1. Weisler RH, Cutler AJ, Ballenger JC, Post RM, Ketter TA. The use of antiepileptic drugs in bipolar disorders: a review based on evidence from controlled trials. CNS Spectr. 2006;11(10):788–99.
    1. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18. doi: 10.1186/1741-7015-8-18.
    1. Cohen J. Statistical power analysis for the behavior sciences. 2. Hillsdale, NJ: Erlbaum; 1988.
    1. Hirschfeld RMA, Calabrese JR, Frye MA, Lavori PW, Sachs G, Tase M, Wagner KD. Defining the clinical course of bipolar disorder: response, remission, relapse, recurrence, and roughening. Psychopharmacol Bull. 2007;40(3):7–14.
    1. Bauer M, Alda M, Priller J, Young LT. International Group For The Study Of Lithium Treated Patients (IGSLI) Implications of the neuroprotective effects of lithium for the treatment of bipolar and neurodegenerative disorders. Pharmacopsychiatry. 2003;36(Suppl 3):S250–4.
    1. Tohen M, Frank E, Bowden CL, Colom F, Ghaemi SN, Yatham LN, Malhi GS, Calabrese JR, Nolen WA, Vieta E, Kapczinski F, Goodwin GM, Suppes T, Sachs GS, Chengappa KR, Grunze H, Mitchell PB, Kanba S, Berk M. The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009;11(5):453–73. doi: 10.1111/j.1399-5618.2009.00726.x.
    1. Vieta PE, Torrent FC, Martínez-Arán A, Colom VF, Reinares GM, Benabarre HA, Comes FM, Goikolea AJM. A user-friendly scale for the short and long term outcome of bipolar disorder: the CGI-BP-M. Actas Esp Psiquiatr. 2002;30(5):301–4.
    1. Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K. The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987;334:1–100. doi: 10.1111/j.1600-0447.1987.tb10566.x.
    1. The WHOQOL Group. What Quality of Life? World Health Forum. WHO: Geneva; 1996. pp. 354–56.
    1. Weissman MM, Bothwell S. Assessment of social adjustment by patient self-report. Arch Gen Psychiatry. 1976;33:1111–5.
    1. Fleck MPA. O instrumento de avaliação de qualidade de vida da Organização Mundial da Saúde (WHOQOL-100): características e perspectivas. Ciênc. Saúde Coletiva. 2000;5(1):33–38. doi: 10.1590/S1413-81232000000100004.
    1. Gorenstein C, Andrade L, Moreno RA, Bernik MA, Nicastri S, Cordás TA, Camargo AP. In: Escalas de avaliação clínica em psiquiatria e psicofarmacologia. São Paulo: Lemos. Gorenstein C, Andrade LHSG, Zuardi AW, editor. 2000. Escala de auto-avaliação de adequação social: validação da versão em língua portuguesa; pp. 401–414.
    1. Spreen O, Strauss E. A Compendium of neuropsychological tests. Oxford: Oxford University Press; 1998.
    1. Wechsler D. Wechsler Abbreviated Scale of Inteligence. New York: Psychological Corporation; 1999.

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