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      Relationship between response to aripiprazole once-monthly and paliperidone palmitate on work readiness and functioning in schizophrenia: A post-hoc analysis of the QUALIFY study

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          Abstract

          Schizophrenia is a chronic disease with negative impact on patients’ employment status and quality of life. This post-hoc analysis uses data from the QUALIFY study to elucidate the relationship between work readiness and health-related quality of life and functioning. QUALIFY was a 28-week, randomized study (NCT01795547) comparing the treatment effectiveness of aripiprazole once-monthly 400 mg and paliperidone palmitate once-monthly using the Heinrichs-Carpenter Quality-of-Life Scale as the primary endpoint. Also, patients’ capacity to work and work readiness (Yes/No) was assessed with the Work Readiness Questionnaire. We categorized patients, irrespective of treatment, by work readiness at baseline and week 28: No to Yes (n = 41), Yes to Yes (n = 49), or No at week 28 (n = 118). Quality-of-Life Scale total, domains, and item scores were assessed with a mixed model of repeated measures. Patients who shifted from No to Yes in work readiness showed robust improvements on Quality-of-Life Scale total scores, significantly greater than patients not ready to work at week 28 (least squares mean difference: 11.6±2.6, p<0.0001). Scores on Quality-of-Life Scale instrumental role domain and items therein–occupational role, work functioning, work levels, work satisfaction–significantly improved in patients shifting from No to Yes in work readiness (vs patients No at Week 28). Quality-of-Life Scale total scores also significantly predicted work readiness at week 28. Overall, these results highlight a strong association between improvements in health-related quality of life and work readiness, and suggest that increasing patients’ capacity to work is an achievable and meaningful goal in the treatment of impaired functioning in schizophrenia.

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          Most cited references 16

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            The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome.

            There is growing interest in deficit symptoms in studies of the course and treatment response of schizophrenia. However, existing clinical assessment instruments focus primarily on productive symptoms. The authors describe the Quality of Life Scale (QLS), a 21-item scale based on a semistructured interview designed to assess deficit symptoms and thereby fill an important gap in the range of instruments now available. Data regarding reliability and training in the use of the QLS are presented. A factor analysis of the items yields results compatible with the conceptual model on which the scale is based. The factor analysis was also performed separately by sex and was fundamentally similar for men and women.
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              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.

              Abstract These updated guidelines are based on a first edition of the World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia published in 2006. For this 2012 revision, all available publications pertaining to the biological treatment of schizophrenia were reviewed systematically to allow for an evidence-based update. These guidelines provide evidence-based practice recommendations that are clinically and scientifically meaningful. They are intended to be used by all physicians diagnosing and treating people suffering from schizophrenia. Based on the first version of these guidelines, a systematic review of the MEDLINE/PUBMED database and the Cochrane Library, in addition to data extraction from national treatment guidelines, has been performed for this update. The identified literature was evaluated with respect to the strength of evidence for its efficacy and then categorised into six levels of evidence (A-F) and five levels of recommendation (1-5) ( Bandelow et al. 2008a ,b, World J Biol Psychiatry 9:242, see Table 1 ). This second part of the updated guidelines covers long-term treatment as well as the management of relevant side effects. These guidelines are primarily concerned with the biological treatment (including antipsychotic medication and other pharmacological treatment options) of adults suffering from schizophrenia.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                24 August 2017
                2017
                : 12
                : 8
                Affiliations
                [1 ] Department of Psychiatry and Human Behavior, University of California, Irvine, California, United States of America
                [2 ] Otsuka Pharmaceutical Europe Limited., Wexham, United Kingdom
                [3 ] Lundbeck LLC, Paramus, New Jersey, United States of America
                [4 ] Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, United States of America
                [5 ] Lundbeck SAS, Issy-les-Moulineaux, France
                [6 ] H. Lundbeck A/S, Valby, Denmark
                [7 ] Lundbeck LLC, Deerfield, Illinois, United States of America
                [8 ] Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
                University of California San Francisco School of Medicine, UNITED STATES
                Author notes

                Competing Interests: The authors declare the following conflicts of interest: Potkin SG has received grant support, funding, or honoraria or served as a consultant for the following companies that conducted scientific or medical research and/or marketed medications related to psychiatric and neurodegenerative disorders: Alkermes, Amgen, Baylor University, Eisai, Eli Lilly and Company, Forest, FORUM Pharmaceuticals, Lundbeck, Merck & Co., Inc., NIH, Novartis, Otsuka, Roche/Genentech, Sunovion Pharmaceuticals Inc., Takeda Pharmaceutical Company Ltd., Toyama, University of Southern California, UCSD, UCSF and Vanda Pharmaceuticals. Naber D: Advisory boards for Janssen/Cilag, Eli Lilly, Lundbeck, Otsuka and Servier; speaker honoraria from Astra Zeneca, Janssen/Cilag, Eli Lilly, Lundbeck and Otsuka. Loze JY: full-time employee of Otsuka Pharmaceutical Europe Ltd. Forray C, Sapin C, Beillat M, Nylander AG, Hertel P, Schmidt SN, Ettrup A, Eramo A, Hansen K: full-time employees of Lundbeck. Baker RA, Peters-Strickland T: full-time employees of Otsuka Pharmaceutical Development & Commercialization, Inc. Authors' employment by study sponsors does not alter our adherence to PLOS ONE policies on sharing data and materials.

                • Conceptualization: SGP JYL CF RAB CS TP-S MB AGN PH SNS A. Ettrup A. Eramo KH DN.

                • Data curation: SNS.

                • Formal analysis: SNS.

                • Funding acquisition: TP-S AGN.

                • Investigation: A. Ettrup SNS.

                • Methodology: A. Ettrup SNS.

                • Project administration: A. Ettrup SNS.

                • Resources: SNS.

                • Software: SNS.

                • Supervision: TP-S AGN.

                • Validation: SNS.

                • Visualization: A. Ettrup.

                • Writing – original draft: A. Ettrup.

                • Writing – review & editing: SGP JYL CF RAB CS TP-S MB AGN PH SNS A. Ettrup A. Eramo KH DN.

                Article
                PONE-D-16-47464
                10.1371/journal.pone.0183475
                5570322
                28837593
                © 2017 Potkin et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 3, Tables: 2, Pages: 12
                Product
                Funding
                Funded by: H. Lundbeck A/S
                Funded by: Otsuka Pharmaceutical Development and Commercialization, Inc.
                This work was supported by H. Lundbeck A/S and Otsuka Pharmaceutical Development & Commercialization, Inc. Authors Forray C, Sapin C, Beillat M, Nylander AG, Hertel P, Schmidt SN, Ettrup A, Eramo A, and Hansen K are employed by H. Lundbeck A/S; authors Baker RA and Peters-Strickland T are employed by Otsuka Pharmaceutical Development & Commercialization, Inc.; and author Loze JY is employed by Otsuka Pharmaceutical Europe Ltd. The specific roles of these authors are articulated in the 'author contributions' section. The funders provided support in the form of salaries for these authors, and were involved in the study design, data collection and analysis, the decision to publish, and preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Schizophrenia
                Medicine and Health Sciences
                Health Care
                Patients
                Medicine and Health Sciences
                Health Care
                Quality of Life
                Medicine and Health Sciences
                Public and Occupational Health
                Behavioral and Social Aspects of Health
                Biology and Life Sciences
                Psychology
                Psychometrics
                Social Sciences
                Psychology
                Psychometrics
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Antipsychotics
                Biology and Life Sciences
                Behavior
                Motivation
                Biology and Life Sciences
                Neuroscience
                Cognitive Science
                Cognitive Psychology
                Motivation
                Biology and Life Sciences
                Psychology
                Cognitive Psychology
                Motivation
                Social Sciences
                Psychology
                Cognitive Psychology
                Motivation
                Medicine and Health Sciences
                Pharmaceutics
                Drug Therapy
                Custom metadata
                Otsuka and Lundbeck are committed to sharing data in accordance with the EFPIA/PhRMA principles for responsible sharing of clinical trial data guidelines and as required by applicable legislation. Legitimate research requests will be considered. Research proposals requesting patient-level data are reviewed by an Independent Review Panel at WIRB Copernicus Group ( https://drc.irbnet.org/release/images/WCG-DRC-Bio.pdf). For inquiries on availability of data of interest, researchers should contact Otsuka ( DT-inquiry@ 123456otsuka.jp ). Please visit https://clinical-trials.otsuka.com/For-Researchers.aspx for further details. Data may be made available following review of a research proposal by the Independent Review Panel at WIRB Copernicus Group for researchers who meet the criteria for access to confidential data.

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