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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole

Authors: Giovani Missio, Doris Hupfeld Moreno, Fernando Fernandes, Danielle Soares Bio, Márcio Gehardt Soeiro-de-Souza, Domingos Rodrigues dos Santos Jr, Denise Petresco David, Luis Felipe Costa, Frederico Navas Demétrio, Ricardo Alberto Moreno

Published in: Trials | Issue 1/2013

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Abstract

Background

The treatment of bipolar disorder (BD) remains a challenge due to the complexity of the disease. Current guidelines represent an effort to assist clinicians in routine practice but have several limitations, particularly concerning long-term treatment. The ARIQUELI (efficacy and tolerability of the combination of lithium or aripiprazole in young bipolar non or partial responders to quetiapine monotherapy) study aims to evaluate two different augmentation strategies for quetiapine nonresponders or partial responders in acute and maintenance phases of BD treatment.

Methods/Design

The ARIQUELI study 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 40 years, are eligible. After diagnostic assessments, patients initiated treatment in phase I with quetiapine. Nonresponders or partial responders after 8 weeks are allocated into one of two groups, potentiated with either lithium (0.5 to 0.8 mEq/l) or aripiprazole (10 or 15 mg). 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 blinded to the treatment. The primary outcome is the evaluation of changes in mean scores on the CGI-BP-M between baseline and the endpoint at the end of each study phase.

Discussion

The ARIQUELI study is currently in progress, with patients undergoing acute treatment (phase I), potentiation (phase II) and maintenance (phase III). The study will be extended until January 2015. Trials comparing lithium and aripiprazole with potentiate treatment in young BD I nonresponders to quetiapine in monotherapy can provide relevant information on the safety of these drugs in clinical practice. Long-term treatment is an issue of great importance and should be evaluated further through more in-depth studies given that BD is a chronic disease.

Trial registration

ClinicalTrials.gov identifier: NCT01710163
Literature
1.
Goldberg JF: Optimizing treatment outcomes in bipolar disorder under ordinary conditions. J Clin Psychiatry. 2008, 69 (Suppl 3): 11-19.PubMed
2.
American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 2000, Washington DC: American Psychiatric Association, Fourth
3.
Beyer JL: An evidence-based medicine strategy for achieving remission in bipolar disorder. J Clin Psychiatry. 2008, 69 (Suppl 3): 31-37.PubMed
4.
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 (Suppl 2): 217-224.CrossRefPubMed
5.
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.PubMed
6.
Young AH, MCElroy S, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M, EMBOLDEN I (Trial 001) Investigators: 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 (Suppl 2): 150-162.CrossRefPubMed
7.
Zhornitsky S, Potvin S, Moteshafi H, Dubreucg S, Rompré PP, Stip E: Dose–response and comparative efficacy and tolerability of quetiapine across psychiatric disorders: a systematic review of the placebo-controlled monotherapy and add-on trials. Int Clin Psychopharmacol. 2011, 26 (Suppl 4): 183-192.CrossRefPubMed
8.
Gajwani P, Muzina DJ, Kemp DE, Gao K, Calabrese JR: Update on quetiapine in the treatment of bipolar disorder: results from the BOLDER studies. Neuropsychiatry Dis Treat. 2007, 3 (Suppl 6): 847-853.
9.
Vieta E, Mullen J, Brecher M, Paulsson B, Jones M: 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 (Suppl 6): 923-934.CrossRefPubMed
10.
Li H, Ma C, Wang G, Zhu X, Peng M, Gu N: Response and remission rates in Chinese patients with bipolar mania treated for 4 weeks with either quetiapine or lithium: a randomized and double-blind study. Curr Med Res Opin. 2008, 24 (Suppl 1): 1-10.CrossRefPubMed
11.
Brahm NC, Gutierres SL, Carnahan RM: Quetiapine for acute mania in bipolar disorder. Am J Health Syst Pharm. 2007, 64 (Suppl 10): 1045-1053.CrossRefPubMed
12.
Nivoli AM, Colom F, Murru A, Pacchiarotti I, Castro-Loli P, Gonzáles-Pinto A, Fountoulakis KN, Vieta E: New treatment guidelines for acute bipolar depression: a systematic review. J Affect Disord. 2011, 129 (Suppl 1–3): 14-26.CrossRefPubMed
13.
Tamayo JM, Zarate CA, Vieta E, Vásques G, Tohen M: Level of response and safety of pharmacological monotherapy in the treatment of acute bipolar I disorder phases: a systematic review and meta-analysis. Int J Neuropsychopharmacol. 2010, 13 (Suppl 6): 813-832.CrossRefPubMedPubMedCentral
14.
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.CrossRefPubMed
15.
Moreno RA, Moreno DH, Soares MB, Ratzke R: Anticonvulsivants and antipsychotics in the treatment of bipolar disorder. Rev Bras Psiquiatr. 2004, 3: 37-43.CrossRef
16.
Taveira ACA, Moreno RA: Brazilian psychiatry attitude toward lithium and others mood stabilizers use in the bipolar disorder. Master’s degree dissertation. 2007, School of Medicine, University of São Paulo
17.
Shapiro DA, Renock S, Arrington E, Chiodo LA, Liu LX, Sibley DR, Roth BL, Milman R: Aripiprazole, a novel atypical antipsychotic drug with a unique and robust phamarcology. Neuropsychopharmacology. 2003, 28: 1400-1411. 10.1038/sj.npp.1300203.CrossRefPubMed
18.
Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN: 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: 1458-1496.CrossRef
19.
Dunn RT, Stan VA, Chriki LS, Filkowski MM, Ghaemi SN: A prospective, open label study of aripiprazole mono and adjunctive treatment in acute bipolar depression. J Affect Disord. 2008, 110: 70-74. 10.1016/j.jad.2008.01.004.CrossRefPubMed
20.
Kemp DE, Gilmer WS, Fleck J, Strauss JL, Dago PL, Karaffa M: Aripiprazole augmentation in treatment-resistant bipolar depression: early response and development of akathisia. Prog Neuropsychoparmacol Biol Psychiatry. 2007, 31: 574-577. 10.1016/j.pnpbp.2006.12.009.CrossRef
21.
Ketter TA, Wang PW, Chandler RA, Culver JL, Alarcon AM: Adjunctive aripiprazole in treatment-resistant bipolar depression. Ann Clin Psychiatry. 2006, 18: 169-172. 10.1080/10401230600801176.CrossRefPubMed
22.
McElroy SL, Suppes T, Frye MA, Altshuler LL, Stanford K, Martens B, Leverich GS, Post RM, Keck PE: Open-Label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial. J Affect Disord. 2007, 101: 275-281. 10.1016/j.jad.2006.11.025.CrossRefPubMed
23.
Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH, CN138-135 Study Group: Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo-and lithium-controlled study. J Affect Disord. 2009, 112: 36-49. 10.1016/j.jad.2008.05.014.CrossRefPubMed
24.
Yatham LN: A clinical review of aripiprazole in bipolar depression and maintenance therapy of bipolar disorder. J Affect Disord. 2011, 128 (Suppl 1): S21-S28.CrossRefPubMed
25.
26.
Schulz KF, Altman DG, Moher D, Group C: CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMC Med. 2010, 8 (Suppl 1): 18-CrossRefPubMedPubMedCentral
27.
Cohen J: Statistical power analysis for the behavior science. 1988, Hillsdale, NJ: Erlbaum, 2
28.
Bauer M, Alda M, Priller J, Young LT, International Group for the Study of Lithium Treated Patients: Implications of the neuroprotective effects of lithium for the treatment of bipolar and neurodegenerative disorders. Pharmacopsychiatry. 2003, 36 (Suppl 3): S250-S254.PubMed
29.
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 (Suppl 5): 453-473.CrossRefPubMed
30.
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 (Suppl 3): 7-14.PubMed
31.
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 (Suppl 5): 301-304.
32.
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. 1987, 334 (Suppl 1): 100-
33.
WHO: What quality of life? World Health Organization qualitiy of life assessment. World Health Forum. 1996, 17 (Suppl 4): 354-356.
34.
Weissman MM, Bothwell S: Assessment of social adjustment by patient self-report. Arch Gen Psychiatry. 1976, 33: 1111-1115. 10.1001/archpsyc.1976.01770090101010.CrossRefPubMed
35.
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 (Suppl 1): 33-38.
36.
Gorenstein C, Andrade L, Moreno RA, Bernik MA, Nicastri S, Cordás TA, Camargo AP: Escala de auto avaliação de adequação social: validação da versão em língua portuguesa. Escalas de avaliação clínica em psiquiatria e psicofarmacologia. Edited by: Gorenstein C, Andrade LHSG, Zuardi AW. 2000, São Paulo: Lemos, 401-414.
37.
Spreen O, Strauss E: A Compendium of neuropsychological tests. 1998, Oxford: Oxford University Press
38.
Wechsler D: Wechsler Abbreviated Scale of Intelligence. 1999, New York: Psychological Corporation
Metadata
Title
The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole
Authors
Giovani Missio
Doris Hupfeld Moreno
Fernando Fernandes
Danielle Soares Bio
Márcio Gehardt Soeiro-de-Souza
Domingos Rodrigues dos Santos Jr
Denise Petresco David
Luis Felipe Costa
Frederico Navas Demétrio
Ricardo Alberto Moreno
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-190

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