51. Multidimensional Assessment of Functional Outcomes in Schizophrenia: Results From QUALIFY, a Head-to-Head Trial of Aripiprazole Once-Monthly and Paliperidone Palmitate
- Author
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Potkin, Steven G, Loze, Jean-Yves, Forray, Carlos, Baker, Ross A, Sapin, Christophe, Peters-Strickland, Timothy, Beillat, Maud, Nylander, Anna-Greta, Hertel, Peter, Schmidt, Simon Nitschky, Eramo, Anna, Hansen, Karina, and Naber, Dieter
- Subjects
Biological Psychology ,Pharmacology and Pharmaceutical Sciences ,Biomedical and Clinical Sciences ,Psychology ,Brain Disorders ,Mental Health ,Clinical Trials and Supportive Activities ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Adult ,Antipsychotic Agents ,Aripiprazole ,Employment ,Female ,Humans ,Male ,Paliperidone Palmitate ,Patient Satisfaction ,Psychiatric Status Rating Scales ,Quality of Life ,Schizophrenia ,Severity of Illness Index ,Single-Blind Method ,Surveys and Questionnaires ,Treatment Outcome ,aripiprazole once-monthly ,paliperidone palmitate ,quality of life ,functioning ,schizophrenia ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Psychiatry ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundQUALIFY was a 28-week, randomized, open-label, head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with aripiprazole once-monthly 400 mg vs paliperidone palmitate.MethodsSecondary effectiveness assessments included physician-rated readiness for work using the Work Readiness Questionnaire, the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales, and quality of life with the rater-blinded Heinrichs-Carpenter Quality of Life Scale. Patients assessed their treatment satisfaction and quality of life with Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life questionnaires.ResultsOdds of being ready for work at week 28 were significantly higher with aripiprazole once-monthly 400 mg vs paliperidone palmitate (adjusted odds ratio, 2.67; 95% CI, 1.39-5.14; P=.003). Aripiprazole once-monthly 400 mg produced numerically or significantly greater improvements from baseline vs paliperidone palmitate in all Quality of Life Scale items. With aripiprazole once-monthly 400 mg vs paliperidone palmitate at week 28, there were significantly more Clinical Global Impression-Severity and Clinical Global Impression-Improvement responders (adjusted odds ratio, 2.26; P=.010, and 2.51; P=.0032) and significantly better Clinical Global Impression-Improvement scores (least squares mean treatment difference, -0.326; 95% CI, -0.60 to -0.05; P=.020). Numerically larger improvements with aripiprazole once-monthly 400 mg vs paliperidone palmitate were observed for patient-rated scales Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life. Partial correlations were strongest among clinician-rated and among patient-rated scales but poorest between clinician and patient-rated scales.ConclusionsConsistently greater improvements were observed with aripiprazole once-monthly 400 mg vs paliperidone palmitate across all measures. Partial correlations between scales demonstrate the multidimensionality of various measures of improvement. More patients on aripiprazole once-monthly 400 mg were deemed ready to work by the study end.Trial registryNational Institutes of Health registry, NCT01795547, https://clinicaltrials.gov/ct2/results?id=NCT01795547).
- Published
- 2017