title: Multidimensional Assessment of Functional Outcomes in Schizophrenia: Results From QUALIFY, a Head-to-Head Trial of Aripiprazole Once-Monthly and Paliperidone Palmitate.
abstract: QUALIFY 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.
  
  
  
  Secondary 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.
  
  
  
  Odds 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.
  
  
  
  Consistently 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.
  
  
  
  National Institutes of Health registry, NCT01795547, https://clinicaltrials.gov/ct2/results?id=NCT01795547).
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Potkin
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Loze
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Carlos
authors.initials: C
authors.lastname: Forray
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Christophe
authors.initials: C
authors.lastname: Sapin
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Maud
authors.initials: M
authors.lastname: Beillat
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Anna-Greta
authors.initials: AG
authors.lastname: Nylander
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Hertel
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Simon
authors.initials: S
authors.lastname: Nitschky Schmidt
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Karina
authors.initials: K
authors.lastname: Hansen
authors.affiliation: University of California, Irvine, CA; Otsuka Pharmaceutical Europe, Wexham, UK; Lundbeck LLC, Paramus, NJ; Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ; Lundbeck SAS, Issy-les-Moulineaux, France; H. Lundbeck A/S, Valby, Denmark; Lundbeck LLC, Deerfield, IL; University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole / Q000009:adverse effects / Q000627:therapeutic use*; D004651:Employment; D005260:Female; D006801:Humans; D008297:Male; D000068882:Paliperidone Palmitate / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012559:Schizophrenia / Q000188:drug therapy*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole; D000068882:Paliperidone Palmitate
keywords: aripiprazole once-monthly; functioning; paliperidone palmitate; quality of life; schizophrenia