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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: [email protected])
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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.

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