Skip to main content
SpringerLink
Log in

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

  • Original Paper
  • Published:
European Archives of Psychiatry and Clinical Neuroscience Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

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

    PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    PubMed  Google Scholar 

  5. 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 27:1–13

    Article  PubMed  CAS  Google Scholar 

  6. 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 34:82–92

    Article  PubMed  CAS  Google Scholar 

  7. 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 373:31–41

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

  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 141:61–69

    Article  PubMed  Google Scholar 

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

    PubMed  CAS  Google Scholar 

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

    PubMed  Google Scholar 

  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 77:215–227

    Article  PubMed  Google Scholar 

  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 35:2367–2377

    Article  PubMed  CAS  Google Scholar 

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

    Google Scholar 

  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 346:16–22

    Article  PubMed  CAS  Google Scholar 

  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 58:538–546

    Article  PubMed  CAS  Google Scholar 

  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 162:441–449

    Article  PubMed  Google Scholar 

  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):15–21

    Article  PubMed  CAS  Google Scholar 

  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

    Google Scholar 

  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 34:220–233

    Article  PubMed  Google Scholar 

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

    Article  PubMed  Google Scholar 

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

    Google Scholar 

  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 6:3

    Article  PubMed  Google Scholar 

  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 67:1942–1947

    Article  PubMed  CAS  Google Scholar 

  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 64:1048–1056

    Article  PubMed  CAS  Google Scholar 

  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 39:135–141

    Article  PubMed  CAS  Google Scholar 

  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

Download references

Acknowledgments

The study, editorial and writing support were sponsored by Janssen Pharmaceutical Companies of Johnson & Johnson in EMEA. The authors would like to acknowledge Dr Rossella Medori for trial design and medical conduct supervision. Dr Medori was European Medical Director at Janssen–Cilag during study conduct and analysis. Paul Bergmans from Janssen–Cilag BV, Netherlands, is also acknowledged for providing statistical analyses. Editorial and writing support was provided by Remon van den Broek and team from Excerpta Medica.

Conflict of interest

Dr De Arce has received research grants, and served as consultant, advisor, or speaker for the following companies: AstraZeneca, Bristol–Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen–Cilag, Novartis, Bristol, Pfizer Inc, sanofi-aventis, and UCB Pharma. Dr Eding declares to have no conflict of interest. Dr Marques–Teixeira declares to have no conflict of interest. Dr Milanova declares to have no conflict of interest. Dr Rancans has received speaker fees from Gedeon Richter, Grindeks, sanofi-aventis, and Servier, consultancy fees from Gedeon Richter; and investigator fees from Janssen–Cilag. Dr Schreiner is a full employee of Janssen–Cilag GmbH, Germany.

Author information

Authors and Affiliations

  1. Servicio de Psiquiatría, Clínica Puerta de Hierro, Hospital Universitario Puerta de Hierro, Manuel de Falla 1, Majadahonda, 28222, Madrid, Spain

    Rosario de Arce Cordón

  2. Psychiatry Department, North Estonian Regional Hospital, Paldiski Maantee 52, 10614, Tallinn, Estonia

    Evelin Eding

  3. Mental Health and Psychiatric Research Unit, Psychiatric Hospital Conde de Ferreira, Porto University, Campo 24 de Agosto, 129 S 601, 4300 504, Porto, Portugal

    Joao Marques-Teixeira

  4. Department of Psychiatry, Alexander University Hospital, Georgi Sofiisky str 1, 1431, Sofia, Bulgaria

    Vihra Milanova

  5. Department of Psychiatry, Riga Stradins University, Tvaika str 2, Riga, LV, 1005, Latvia

    Elmars Rancans

  6. Medical Affairs EMEA, Janssen-Cilag GmbH, Johnson & Johnson Platz 1, 41470, Neuss, Germany

    Andreas Schreiner

Authors
  1. Rosario de Arce Cordón
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Evelin Eding
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Joao Marques-Teixeira
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Vihra Milanova
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Elmars Rancans
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Andreas Schreiner
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Rosario de Arce Cordón.

Rights and permissions

Reprints and permissions

About this article

Cite this article

de Arce Cordón, R., Eding, E., Marques-Teixeira, J. et al. Descriptive analyses of the aripiprazole arm in the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE). Eur Arch Psychiatry Clin Neurosci 262, 139–149 (2012). https://doi.org/10.1007/s00406-011-0220-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00406-011-0220-8

Keywords

Search

Navigation