title: Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia.
abstract: OBJECTIVE
  To directly compare aripiprazole once-monthly 400mg (AOM 400) and paliperidone palmitate once-monthly (PP) on the Heinrichs-Carpenter Quality-of-Life Scale (QLS), a validated health-related quality of life and functioning measure in schizophrenia.
  
  
  METHODS
  This 28-week, randomized, non-inferiority, open-label, rater-blinded, head-to-head study (QUALIFY) of AOM 400 and PP in adult patients (18-60 years) comprised oral conversion, initiation of AOM 400 or PP treatment, and continuation with intramuscular injections every 4weeks. The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements.
  
  
  RESULTS
  Of 295 randomized patients, 100/148 (67.6%) of AOM 400 and 83/147 (56.5%) of PP patients completed 28weeks of treatment. A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score (4.67 [95%CI: 0.32;9.02], p=0.036) confirmed non-inferiority and established superiority of AOM 400 vs PP. There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator's Assessment Questionnaire for AOM 400 vs PP, and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years. Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400, and adverse events were the most frequent reason for discontinuation (27/137 [19.7%] for PP and 16/144 [11.1%] for AOM 400). All-cause discontinuation was numerically lower with AOM 400.
  
  
  CONCLUSIONS
  Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate. ClinicalTrials.gov identifier:NCT01795547.
authors.affiliation: Department for Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Naber
authors.affiliation: Lundbeck SAS, Quai du Président Roosevelt 37-45, 92445 Issy-les-Moulineaux, France.
authors.forename: Karina
authors.initials: K
authors.lastname: Hansen
authors.affiliation: Lundbeck Research US, 215 College Rd, Paramus, NJ 07652, United States.
authors.forename: Carlos
authors.initials: C
authors.lastname: Forray
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, United States.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: Lundbeck SAS, Quai du Président Roosevelt 37-45, 92445 Issy-les-Moulineaux, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Sapin
authors.affiliation: Lundbeck SAS, Quai du Président Roosevelt 37-45, 92445 Issy-les-Moulineaux, France.
authors.forename: Maud
authors.initials: M
authors.lastname: Beillat
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, United States.
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.affiliation: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
authors.forename: Anna-Greta
authors.initials: AG
authors.lastname: Nylander
authors.affiliation: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Hertel
authors.affiliation: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
authors.forename: Henrik Steen
authors.initials: HS
authors.lastname: Andersen
authors.affiliation: Lundbeck LLC, 4 Parkway North, Deerfield, IL 60015, United States.
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.affiliation: Otsuka Pharmaceutical Europe Ltd, Gallions Wexham Springs, Framewood Road, Wexham SL3 6PJ, United Kingdom.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Loze
authors.affiliation: Department of Psychiatry and Human Behavior, University of California, Irvine, 5251 California Ave, Irvine, CA 92617, United States.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Potkin
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068180:Aripiprazole / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D000068882:Paliperidone Palmitate / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012559:Schizophrenia / Q000188:drug therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole; D000068882:Paliperidone Palmitate
keywords: Antipsychotic treatment; Aripiprazole; Clinical trial; Functioning; Long-acting injectable; QLS