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Psych Congress  

Assessing the Effectiveness of Aripiprazole Once-monthly vs. Paliperidone Palmitate for the Long-term Treatment of Schizophrenia

Authors  
Ross Baker, PhD, MBA. Karina Hansen, MSc, PhD. Timothy Peters-Strickland, MD. Carlos Forray, MD. Anna G. Nylander, PhD. Maud Beillat, MSc. Christophe Sapin, MSc (stat) MSc (econ). Joan Zhao, PhD. Peter Hertel, PhD. Jean-Yves Loze, MD, MSc.
Sponsor  
Otsuka Pharmaceutical Development and Commercialization, Inc. and H. Lundbeck A/S

OBJECTIVES: The relative benefits of available antipsychotics in the long-term treatment of schizophrenia are mostly documented by indirect comparisons in the literature, and are often subject to controversy.. Health-related quality-of-life is well established effectiveness endpoint. This poster presents the overall study design of QUALIFY, a direct comparative study between aripiprazole once-monthly formulation and paliperidone palmitate, a long-acting formulation commonly used in the treatment of schizophrenia. 
METHODS: The QUALIFY study is a 28-week, multi-national, randomized, open-label, rater-blinded, parallel-group, comparative effectiveness study comparing aripiprazole once-monthly with paliperidone palmitate on health-related quality of life, as measured by the Heinrichs–Carpenter Quality of Life Scale (QLS), in a close to real-life setting. Eligible patients aged between 18–60 years, with a current diagnosis of schizophrenia (DSM-IV-TR criteria)requiring chronic antipsychotic treatment are being recruited. Patients are being stratified according to age (≤35 and >35 years), randomized, and converted from other antipsychotics to oral aripiprazole (10–30 mg/day) or paliperidone (3–12 mg/day), followed by a 6-month course of treatment with either aripiprazole once-monthly or paliperidone palmitate long-acting injectable formulations. The primary effectiveness endpoint is the QLS; additional assessments will include (among others) the Investigator’s Assessment Questionnaire, Clinical Global Impressions scales, and the Readiness to Work Questionnaire. Pharmaco-economic and safety assessments will also be performed. 
CONCLUSIONS: Assessment of patient health-related quality of life, as well as other patient-relevant outcomes, allows for a more thorough assessment of comparative treatment effectiveness than traditional assessments of relapse or remission, and is representative of an everyday clinical practice setting.  

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