title: Effects of aripiprazole once-monthly on domains of personal and social performance: results from 2 multicenter, randomized, double-blind studies.
abstract: OBJECTIVE
  To assess the effects of maintenance therapy with aripiprazole once-monthly 400mg on personal and social functioning.
  
  
  METHODS
  Data were analyzed from 2 randomized, double-blind trials of patients with schizophrenia requiring chronic antipsychotic treatment. One study was a 52-week trial of aripiprazole once-monthly 400mg versus placebo; the other was a 38-week trial of aripiprazole once-monthly 400mg, oral aripiprazole (10-30 mg daily), and aripiprazole once-monthly 50mg (subtherapeutic dose to test assay sensitivity). Functioning was assessed using the Personal and Social Performance (PSP) scale, comprising 4 domain subscales.
  
  
  RESULTS
  In the 52-week study, 403 patients stabilized on aripiprazole once-monthly 400mg were randomized to receive aripiprazole once-monthly 400mg (n=269) or placebo (n=134). In the 38-week study, 662 patients stabilized on oral aripiprazole were randomized to receive aripiprazole once-monthly 400mg (n=265), oral aripiprazole (n=266), or aripiprazole once-monthly 50mg (subtherapeutic dose; n=131). In the 52-week study, mean changes from baseline were significantly worsened with placebo compared with aripiprazole once-monthly 400mg for PSP total score (P<0.001) and domain scores for Personal and Social Relationships (P<0.001), Self-Care (P<0.01), and Disturbing and Aggressive Behavior (P<0.0001). In the 38-week study, mean changes from baseline were significantly worsened with aripiprazole once-monthly 50mg compared with aripiprazole once-monthly 400mg for PSP total score (P<0.05) and the Personal and Social Relationships domain score (P<0.05).
  
  
  CONCLUSIONS
  Patient functioning, assessed using the PSP scale, was maintained in stabilized patients treated with aripiprazole once-monthly in 2 pivotal relapse studies.
authors.affiliation: Department of Psychiatry and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria. Electronic address: wolfgang.fleischhacker@i-med.ac.at.
authors.forename: W Wolfgang
authors.initials: WW
authors.lastname: Fleischhacker
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: Lundbeck LLC, Deerfield, IL, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Lan-Feng
authors.initials: LF
authors.lastname: Tsai
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Perry
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Johnson
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.affiliation: The Zucker Hillside Hospital, Glen Oaks, NY, USA; Hofstra North Shore-LIJ School of Medicine, Hempstead, NY, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000068180:Aripiprazole; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000494:pharmacology*; D015363:Quinolones / Q000008:administration & dosage / Q000494:pharmacology*; D012559:Schizophrenia / Q000188:drug therapy*; D012648:Self Care; D012919:Social Behavior; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole
keywords: Antipsychotics; Aripiprazole once-monthly; Long-acting injectable; Patient function; Psychosocial function; Schizophrenia