title: Aripiprazole Once-Monthly in the Treatment of Acute Psychotic Episodes in Schizophrenia: Post Hoc Analysis of Positive and Negative Syndrome Scale Marder Factor Scores.
abstract: BACKGROUND
  Long-acting injectable antipsychotics are treatment options for acute and long-term treatment of patients with schizophrenia. In a previously published 12-week randomized, double-blind, placebo-controlled clinical trial of patients with schizophrenia experiencing an acute psychotic episode, aripiprazole once-monthly 400 mg (AOM 400) produced significantly greater improvement than placebo on the primary endpoint, Positive and Negative Syndrome Scale (PANSS) total score at week 10.
  
  
  METHODS
  To examine the efficacy of AOM 400 across a broader representation of schizophrenia symptoms, including agitation, a post hoc analysis of this trial was carried out to assess the change in PANSS Marder factor domains (positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression) and the PANSS excited component (equivalent to Marder factor domain uncontrolled hostility/excitement plus the tension item) by comparing differences in change from baseline between AOM 400 and placebo using a mixed model for repeated measures.
  
  
  RESULTS
  The differences between treatment and placebo for all factors were statistically significant, with improvements seen as early as week 1 or 2, and maintained through week 12. Thus, AOM 400, supplemented with oral aripiprazole in the first 2 weeks, showed significantly greater efficacy versus placebo in acutely ill patients with schizophrenia in all 5 Marder illness domains, as well as in agitation as conceptualized by the PANSS excited component score.
  
  
  CONCLUSIONS
  These findings indicate that AOM 400 is efficacious across the spectrum of schizophrenia symptoms in acutely ill patients, with implications for both short-term and, by extension, long-term patient outcomes.
authors.affiliation: From the Departments of *Psychiatry and †Neurology, Hotchkiss Brain Institute, University of Calgary, Calgary, Canada; ‡Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ; §Otsuka Canada Pharmaceutical, Inc, Quebec, Canada; ∥H. Lundbeck A/S, Copenhagen-Valby, Denmark; ¶Lundbeck LLC, Deerfield, IL; #Otsuka Pharmaceutical Development & Commercialization, Inc, Rockville, MD; **The Zucker Hillside Hospital, Glen Oaks and ††Hofstra Northwell School of Medicine, Hempstead, NY.
authors.forename: Zahinoor
authors.initials: Z
authors.lastname: Ismail
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
authors.forename: Maia
authors.initials: M
authors.lastname: Miguelez
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.forename: Peter
authors.initials: P
authors.lastname: Hertel
authors.forename: Anna
authors.initials: A
authors.lastname: Eramo
authors.forename: Na
authors.initials: N
authors.lastname: Jin
authors.forename: Pamela
authors.initials: P
authors.lastname: Perry
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D000068180:Aripiprazole / Q000008:administration & dosage* / Q000494:pharmacology*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D006801:Humans; D017063:Outcome Assessment, Health Care; D011618:Psychotic Disorders / Q000188:drug therapy*; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000068180:Aripiprazole