title: Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate aripiprazole once-monthly (AOM), a long-acting injectable suspension of aripiprazole, as acute treatment in patients with schizophrenia (DSM-IV-TR).
  
  
  METHODS
  Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo (October 2012-August 2013). The primary efficacy outcome was change from baseline to endpoint (week 10) in Positive and Negative Syndrome Scale (PANSS) total score. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale (PSP) scores. The study took place from October 2012 through August 2013.
  
  
  RESULTS
  Patients (N = 340; 79% male, 66% black) were randomized to AOM (n = 168) or placebo (n = 172). Least squares (LS) mean change from baseline to endpoint (week 10) favored AOM versus placebo in PANSS total (treatment difference, -15.1 [95% CI, -19.4 to -10.8]; P < .0001) and CGI-S (treatment difference, -0.8 [95% CI, -1.1 to -0.6]; P < .0001) scores, as it did at all other timepoints through 12 weeks (all P ≤ .0005). LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo (P < .0001). Common (> 10%) treatment-emergent adverse events (AOM vs. placebo) were increased weight (16.8% vs 7.0%), headache (14.4% vs. 16.3%), and akathisia (11.4% vs 3.5%).
  
  
  CONCLUSIONS
  Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia, with acceptable safety and tolerability. These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01663532.
authors.affiliation: The Zucker Hillside Hospital, 75-59 263rd St, Kaufmann Bldg, Ste 103, Glen Oaks, NY 11004-1100 jkane2@nshs.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
authors.forename: Timothy
authors.initials: T
authors.lastname: Peters-Strickland
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 P
authors.initials: PP
authors.lastname: Perry
authors.forename: Michelle
authors.initials: M
authors.lastname: Gara
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D000068180:Aripiprazole; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D010919:Placebos; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D010879:Piperazines; D010919:Placebos; D015363:Quinolones; D000068180:Aripiprazole