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European Archives of Psychiatry and Clinical Neuroscience

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01-03-2012 | Original Paper

Descriptive analyses of the aripiprazole arm in the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

Authors: Rosario de Arce Cordón, Evelin Eding, Joao Marques-Teixeira, Vihra Milanova, Elmars Rancans, Andreas Schreiner

Published in: European Archives of Psychiatry and Clinical Neuroscience | Issue 2/2012

Abstract

A recent randomized, open-label, relapse prevention trial (ConstaTRE) compared outcomes with risperidone long-acting injectable (RLAI) versus the oral atypical antipsychotic quetiapine. This study also included a small descriptive arm in which patients could also be randomized to aripiprazole. Results of this exploratory analysis are described here. Clinically stable adults with schizophrenia or schizoaffective disorder previously treated with oral risperidone, olanzapine, or an oral conventional antipsychotic were randomized to RLAI or aripiprazole. Efficacy and tolerability were monitored for up to 24 months. A total of 45 patients were treated with aripiprazole (10–30 mg/day) and 329 patients with RLAI (25–50 mg i.m. every 2 weeks). Relapse occurred in 27.3% (95% CI: 15.0–42.8%) of aripiprazole-treated and 16.5% (95% CI: 12.7–21.0%) of RLAI-treated patients. Kaplan–Meier estimates of mean (standard error) relapse-free period were 313.7 (20.4) days for aripiprazole and 607.1 (11.4) days for RLAI patients. Remission was achieved by 34.1% (95% CI: 20.5–49.9%) of aripiprazole and 51.1% (95% CI: 45.5–56.6%) of RLAI patients. Clinical global impression–change was improved (“minimally improved” to “very much improved”) in 26.4% with RLAI and 15.9% with aripiprazole patients. Tolerability was generally good for both treatment groups. Weight gain (7.0% with RLAI vs. 4.4% with aripiprazole), extrapyramidal adverse events (AEs) (10.3% vs. 4.4%), and potentially prolactin-related AEs (4.6% vs. 0%) were more common with RLAI treatment, and gastrointestinal disorders were more common in aripiprazole-treated patients (22.2% vs. 6.1%). Time-to-relapse in stable patients with schizophrenia or schizoaffective disorder was numerically longer in RLAI-treated patients than in aripiprazole-treated patients although not statistically significant. Both treatments were generally well tolerated.

Schooler NR (2006) Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry 67(suppl 5):19–23PubMed

Altamura AC, Bobo WV, Meltzer HY (2007) Factors affecting outcome in schizophrenia and their relevance for psychopharmacological treatment. Int Clin Psychopharmacol 22:249–267PubMedCrossRef

Rosa MA, Marcolin MA, Elkis H (2005) Evaluation of the factors interfering with drug treatment compliance among Brazilian patients with schizophrenia. Rev Bras Psiquiatr 27:178–184PubMedCrossRef

Leucht S, Heres S (2006) Epidemiology, clinical consequences, and psychosocial treatment of nonadherence in schizophrenia. J Clin Psychiatry 67(suppl 5):3–8PubMed

Cassano GB, Fagiolini A, Lattanzi L, Monteleone P, Niolu C, Sacchetti E, Siracusano A, Vita A (2007) Aripiprazole in the treatment of schizophrenia: a consensus report produced by schizophrenia experts in Italy. Clin Drug Investig 27:1–13PubMedCrossRef

Limosin F, Azorin JM, Krebs MO, Millet B, Glikman J, Camus V, Crocq MA, Costentin J, Daléry J (2008) Present data and treatment schedule of aripiprazole in the treatment of schizophrenia. Encephale 34:82–92PubMedCrossRef

Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM (2009) Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 373:31–41PubMedCrossRef

Dolder CR, Lacro JP, Dunn LB, Jeste DV (2002) Antipsychotic medication adherence: is there a difference between typical and atypical agents? Am J Psychiatry 159:103–108PubMedCrossRef

Kane JM (2007) Treatment adherence and long-term outcomes. CNS Spectr 12(suppl 17):21–26PubMed

10.

Linden M, Godemann F (2007) The differentiation between “lack of insight” and “dysfunctional health beliefs” in schizophrenia. Psychopathology 40:236–241PubMedCrossRef

11.

Löffler W, Kilian R, Toumi M, Angermeyer MC (2003) Schizophrenic patients’ subjective reasons for compliance and noncompliance with neuroleptic treatment. Pharmacopsychiatry 36:105–112PubMedCrossRef

12.

Yamada K, Watanabe K, Nemoto N, Fujita H, Chikaraishi C, Yamauchi K, Yagi G, Asai M, Kanba S (2006) Prediction of medication noncompliance in outpatients with schizophrenia: 2-year follow-up study. Psychiatry Res 141:61–69PubMedCrossRef

13.

Kane JM (2006) Review of treatments that can ameliorate nonadherence in patients with schizophrenia. J Clin Psychiatry 67(suppl 5):9–14PubMed

14.

Schooler NR (2003) Relapse and rehospitalization: comparing oral and depot antipsychotics. J Clin Psychiatry 64(suppl 16):14–17PubMed

15.

Lasser RA, Bossie CA, Gharabawi GM, Kane JM (2005) Remission in schizophrenia: Results from a 1-year study of long-acting risperidone injection. Schizophr Res 77:215–227PubMedCrossRef

16.

Gaebel W, Schreiner A, Bergmans P, de Arce R, Rouillon F, Cordes J, Eriksson L, Smeraldi E (2010) Relapse prevention in schizophrenia and schizoaffective disorder with risperidone long-acting injectable versus quetiapine: results of a long-term, open-label, randomized clinical trial. Neuropsychopharmacology 35:2367–2377PubMedCrossRef

17.

American Psychiatric Association (1994) Diagnostic and statistical manual of mental disorders, 4th edn. American Psychiatric Association, Washington, DC

18.

Csernansky JG, Mahmoud R, Brenner R, Risperidone-USA-79 Study Group (2002) A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. N Engl J Med 346:16–22PubMedCrossRef

19.

Marder SR, Davis JM, Chouinard G (1997) The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry 58:538–546PubMedCrossRef

20.

Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, Marder SR, Weinberger DR (2005) Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry 162:441–449PubMedCrossRef

21.

Kissling W, Heres S, Lloyd K, Sacchetti E, Bouhours P, Medori R, Llorca PM (2005) Direct transition to long-acting risperidone—analysis of long-term efficacy. J Psychopharmacol 19(suppl):15–21PubMedCrossRef

22.

Macfadden W, Ma YW, Thomas Haskins J, Bossie CA, Alphs L (2010) A prospective study comparing the long-term effectiveness of injectable risperidone long-acting therapy and oral aripiprazole in patients with schizophrenia. Psychiatry (Edgmont) 7(11):23–31

23.

Ware J Jr, Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233PubMedCrossRef

24.

Martin CR, Allan R (2007) Factor structure of the Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4). Psychol Health Med 12:126–134PubMedCrossRef

25.

Chouinard G, Ross-Chouinard A, Annable L, Jones BD (1980) Extrapyramidal Symptom Rating Scale. Can J Neurol Sci 7:233

26.

Gharabawi GM, Gearhart NC, Lasser RA, Mahmoud RA, Zhu Y, Mannaert E, Naessens I, Bossie CA, Kujawa M, Simpson GM (2007) Maintenance therapy with once-monthly administration of long-acting injectable risperidone in patients with schizophrenia or schizoaffective disorder: a pilot study of an extended dosing interval. Ann Gen Psychiatry 6:3PubMedCrossRef

27.

Moeller KE, Shireman TI, Liskow BI (2006) Relapse rates in patients with schizophrenia receiving aripiprazole in comparison with other atypical antipsychotics. J Clin Psychiatry 67:1942–1947PubMedCrossRef

28.

Pigott TA, Carson WH, Saha AR, Torbeyns AF, Stock EG, Ingenito GG, Aripiprazole Study Group (2003) Aripirazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study. J Clin Psychiatry 64:1048–1056PubMedCrossRef

29.

Bai YM, Chen TT, Wu B (2006) A comparative efficacy and safety study of long-acting risperidone injection and risperidone oral tablets among hospitalized patients: 12-week randomized, single-blind study. Pharmacopsychiatry 39:135–141PubMedCrossRef

30.

Komossa K, Rummel-Kluge C, Schmid F et al (2010) Quetiapine versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev CD006625

31.

Komossa K, Rummel-Kluge C, Schmid F et al (2009) Aripiprazole versus other atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev CD006569

Title: Descriptive analyses of the aripiprazole arm in the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)
Authors: Rosario de Arce Cordón
Evelin Eding
Joao Marques-Teixeira
Vihra Milanova
Elmars Rancans
Andreas Schreiner
Publication date: 01-03-2012
Publisher: Springer-Verlag
Published in: European Archives of Psychiatry and Clinical Neuroscience / Issue 2/2012
Print ISSN: 0940-1334
Electronic ISSN: 1433-8491
DOI: https://doi.org/10.1007/s00406-011-0220-8

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Descriptive analyses of the aripiprazole arm in the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE)

Abstract

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

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