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Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics

Published online by Cambridge University Press:  17 August 2016

Timothy Peters-Strickland ,
Cathy Zhao ,
Pamela P. Perry ,
Anna Eramo ,
Phyllis M. Salzman ,
Robert D. McQuade ,
Brian R. Johnson  and
Raymond Sanchez
Timothy Peters-Strickland*
Affiliation:
Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Cathy Zhao
Affiliation:
Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Pamela P. Perry
Affiliation:
Clinical Management and Corporate Projects, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Anna Eramo
Affiliation:
Medical Affairs & Phase IV Clinical Affairs, Lundbeck LLC, Deerfield, IL, USA
Phyllis M. Salzman
Affiliation:
Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Robert D. McQuade
Affiliation:
Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Brian R. Johnson
Affiliation:
Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
Raymond Sanchez
Affiliation:
Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA
*
*Address for correspondence: Timothy Peters-Strickland, Senior Director, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, USA. (Email: tim.peters-strickland@otsuka-us.com)
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Abstract

Objective

To assess the effects of aripiprazole once-monthly 400 mg (AOM 400) on clinical symptoms and global improvement in schizophrenia after switching from an oral antipsychotic.

Methods

In a multicenter, open-label, mirror-image, naturalistic study in patients with schizophrenia (>1 year, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR] criteria), changes in efficacy measures were assessed during prospective treatment (6 months) with AOM 400 after switching from standard-of-care oral antipsychotics. During prospective treatment, patients were cross-titrated to oral aripiprazole monotherapy (1–4) weeks followed by open-label AOM 400 (24 weeks). Mean change from baseline of the open-label AOM 400 phase in Positive and Negative Syndrome Scale (PANSS) scores (total, positive and negative subscales) and Clinical Global Impression–Severity (CGI-S) scores; mean CGI–Improvement (CGI-I) score; and proportion of responders (≥30% decrease from baseline in PANSS total score or CGI-I score of 1 [very much improved] or 2 [much improved]) were assessed.

Results

PANSS and CGI-S scores improved from baseline (P<0.0001) and CGI-I demonstrated improvement at all time points. By the end of the study, 49.0% of patients were PANSS or CGI-I responders.

Conclusions

In a community setting, patients with schizophrenia who were stabilized at baseline and switched to AOM 400 from oral antipsychotics showed clear improvements in clinical symptoms.

Keywords

Antipsychotic agentaripiprazole once-monthlylong-acting injectablenaturalistic studyschizophrenia
Type
Original Research
Information
CNS Spectrums , Volume 21 , Issue 6 , December 2016 , pp. 460 - 465
Copyright
© Cambridge University Press 2016 

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Footnotes

Editorial support for the preparation of this manuscript was provided by Amy Roth Shaberman, PhD, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company, with funding from Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S. Anna Duca, RN, BSN, was involved in coordinating the trial and the development of earlier drafts of this manuscript. The authors are entirely responsible for the scientific content of the paper.

Trial registry: ClinicalTrials.gov NCT01432444 http://clinicaltrials.gov/show/NCT01432444.

References

1. Caseiro, O, Perez-Iglesias, R, Mata, I, et al. Predicting relapse after a first episode of non-affective psychosis: a three-year follow-up study. J Psychiatr Res. 2012; 46(8): 1099–1105.CrossRefGoogle ScholarPubMed
2. Hasan, A, Falkai, P, Wobrock, T, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. World J Biol Psychiatry. 2013; 14(1): 2–44.CrossRefGoogle ScholarPubMed
3. Kreyenbuhl, J, Buchanan, RW, Dickerson, FB, Dixon, LB, Schizophrenia Patient Outcomes Research Team. The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2009. Schizophr Bull. 2010; 36(1): 94–103.CrossRefGoogle ScholarPubMed
4. Velligan, DI, Weiden, PJ, Sajatovic, M, et al. The expert consensus guideline series: adherence problems in patients with serious and persistent mental illness. J Clin Psychiatry. 2009; 70(Suppl 4): 1–46; quiz 47–48.Google ScholarPubMed
5. Dibonaventura, M, Gabriel, S, Dupclay, L, Gupta, S, Kim, E. A patient perspective of the impact of medication side effects on adherence: results of a cross-sectional nationwide survey of patients with schizophrenia. BMC Psychiatry. 2012; 12: 20.CrossRefGoogle ScholarPubMed
6. Ascher-Svanum, H, Faries, DE, Zhu, B, et al. Medication adherence and long-term functional outcomes in the treatment of schizophrenia in usual care. J Clin Psychiatry. 2006; 67(3): 453–460.CrossRefGoogle ScholarPubMed
7. Weiden, PJ, Kozma, C, Grogg, A, Locklear, J. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004; 55(8): 886–891.CrossRefGoogle ScholarPubMed
8. Haddad, PM, Brain, C, Scott, J. Nonadherence with antipsychotic medication in schizophrenia: challenges and management strategies. Patient Relat Outcome Meas. 2014; 5: 43–62.CrossRefGoogle ScholarPubMed
9. Asseburg, C, Willis, M, Lothgren, M, et al. Hospitalisation utilisation and costs in schizophrenia patients in Finland before and after initiation of risperidone long-acting injection. Schizophr Res Treat. 2012; 2012: 791468.Google ScholarPubMed
10. Kane, JM, Zhao, C, Johnson, BR, et al. Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis. J Med Econ. 2015; 18(2): 145–154.CrossRefGoogle ScholarPubMed
11. Kishimoto, T, Nitta, M, Borenstein, M, Kane, JM, Correll, CU. Long-acting injectable versus oral antipsychotics in schizophrenia: a systematic review and meta-analysis of mirror-image studies. J Clin Psychiatry. 2013; 74(10): 957–965.CrossRefGoogle ScholarPubMed
12. Taylor, D, Olofinjana, O. Long-acting paliperidone palmitate—interim results of an observational study of its effect on hospitalization. Int Clin Psychopharmacol. 2014; 29(4): 229–234.CrossRefGoogle ScholarPubMed
13. Kane, J, Sanchez, R, Perry, P, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012; 73(5): 617–624.CrossRefGoogle ScholarPubMed
14. Fleischhacker, WW, Sanchez, R, Perry, PP, et al. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014; 205(2): 135–144.CrossRefGoogle ScholarPubMed
15. Kane, JM, Peters-Strickland, T, Baker, RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014; 75(11): 1254–1260.CrossRefGoogle ScholarPubMed
16. Singal, AG, Higgins, PD, Waljee, AK. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol. 2014; 5: e45.CrossRefGoogle ScholarPubMed
17. Kishimoto, T, Robenzadeh, A, Leucht, C, et al. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2014; 40(1): 192–213.CrossRefGoogle ScholarPubMed
18. Kane, JM, Sanchez, R, Zhao, J, et al. Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia. J Med Econ. 2013; 16(7): 917–925.CrossRefGoogle ScholarPubMed
19. Kay, SR, Fiszbein, A, Opler, LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987; 13(2): 261–276.CrossRefGoogle ScholarPubMed
20. Guy, W. Clinical Global Impression Scale (CGI). In. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs; 1976: 217–222.Google Scholar
21. Guy, W. ECDEU Assessment Manual for Psychopharmacology—Revised. Rockville, MD: U.S. Department of Health Services; 1976.Google Scholar
22. Rosa, F, Schreiner, A, Thomas, P, Sherif, T. Switching patients with stable schizophrenia or schizoaffective disorder from olanzapine to risperidone long-acting injectable. Clin Drug Investig. 2012; 32(4): 267–279.CrossRefGoogle ScholarPubMed