title: Mirtazapine add-on therapy in the treatment of schizophrenia with atypical antipsychotics: a double-blind, randomised, placebo-controlled clinical trial.
abstract: OBJECTIVE
  Schizophrenia is a multifaceted illness with positive, negative and cognitive symptom domains. Standard treatments often focus on positive symptoms and may not adequately relieve other symptoms. Previous studies have suggested a role for mirtazapine in schizophrenia, particularly in negative symptoms. This study investigates the efficacy of adding mirtazapine to treatment as usual to alleviate the negative symptoms of schizophrenia.
  
  
  METHODS
  In a 6 week, double-blind clinical trial, participants with a diagnosis of schizophrenia and currently being treated with atypical antipsychotic medication were randomised to adjunctive treatment with mirtazapine (30 mg/day) or placebo. The primary outcome measure was improvement in the Positive and Negative Syndrome Scale (PANSS). Measures of cognition, collected at baseline and week 6 only, were analysed using an Analysis of Covariance (ANCOVA) model. All other outcome measures were analysed using a linear mixed model.
  
  
  RESULTS
  Forty participants were recruited to the study with equal numbers randomised to each treatment arm. There was no significant difference between mirtazapine and placebo treated participants for improvement in PANSS scores or any of the secondary outcome measures at any stage during the 6-week trial.
  
  
  CONCLUSIONS
  This trial does not confirm previous research supporting the use of mirtazapine adjunctive to atypical antipsychotic treatment for schizophrenia.
authors.affiliation: Department of Clinical and Biomedical Sciences: Barwon Health, The University of Melbourne, Geelong, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.forename: Clarissa S
authors.initials: CS
authors.lastname: Gama
authors.forename: Suresh
authors.initials: S
authors.lastname: Sundram
authors.forename: Harry
authors.initials: H
authors.lastname: Hustig
authors.forename: Les
authors.initials: L
authors.lastname: Koopowitz
authors.forename: Russell
authors.initials: R
authors.lastname: D'Souza
authors.forename: Hamish
authors.initials: H
authors.lastname: Malloy
authors.forename: Cate
authors.initials: C
authors.lastname: Rowland
authors.forename: Alison
authors.initials: A
authors.lastname: Monkhouse
authors.forename: Andrew
authors.initials: A
authors.lastname: Monkhouse
authors.forename: Fiona
authors.initials: F
authors.lastname: Bole
authors.forename: Sumathy
authors.initials: S
authors.lastname: Sathiyamoorthy
authors.forename: Danijela
authors.initials: D
authors.lastname: Piskulic
authors.forename: Seetal
authors.initials: S
authors.lastname: Dodd