title: Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial.
abstract: OBJECTIVE
  The efficacy, safety, and tolerability of brexpiprazole and placebo were compared in adults with acute schizophrenia.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled study. Patients with schizophrenia experiencing an acute exacerbation were randomly assigned to daily brexpiprazole at a dosage of 0.25, 2, or 4 mg or placebo (1:2:2:2) for 6 weeks. Outcomes included change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score (primary endpoint measure), Clinical Global Impressions Scale (CGI) severity score (key secondary endpoint measure), and other efficacy and tolerability measures.
  
  
  RESULTS
  The baseline overall mean PANSS total score was 95.2, and the CGI severity score was 4.9. Study completion rates were 62.2%, 68.1%, and 67.2% for patients in the 0.25-, 2-, and 4-mg brexpiprazole groups, respectively, versus 59.2% in the placebo group. At week 6, compared with placebo, brexpiprazole dosages of 2 and 4 mg produced statistically significantly greater reductions in PANSS total score (treatment differences: -8.72 and -7.64, respectively) and CGI severity score (treatment differences: -0.33 and -0.38). The most common treatment-emergent adverse event for brexpiprazole was akathisia (2 mg: 4.4%; 4 mg: 7.2%; placebo: 2.2%). Weight gain with brexpiprazole was moderate (1.45 and 1.28 kg for 2 and 4 mg, respectively, versus 0.42 kg for placebo at week 6). There were no clinically or statistically significant changes from baseline in lipid and glucose levels and extrapyramidal symptom ratings.
  
  
  CONCLUSIONS
  Brexpiprazole at dosages of 2 and 4 mg/day demonstrated statistically significant efficacy compared with placebo and good tolerability for patients with an acute schizophrenia exacerbation.
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Skuban
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: John
authors.initials: J
authors.lastname: Ouyang
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Mary
authors.initials: M
authors.lastname: Hobart
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Pfister
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Margaretta
authors.initials: M
authors.lastname: Nyilas
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
authors.affiliation: From the Zucker Hillside Hospital, Glen Oaks, N.Y.; Otsuka Pharmaceutical Development & Commercialization, Princeton, N.J.; and H. Lundbeck A/S, Valby, Copenhagen, Denmark.
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
mesh_terms: D000208:Acute Disease; D000328:Adult; D017109:Akathisia, Drug-Induced / Q000209:etiology; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D001786:Blood Glucose; D008055:Lipids; D015363:Quinolones; D013876:Thiophenes; C000591922:brexpiprazole