Mirtazapine add-on therapy in the treatment of schizophrenia with atypical antipsychotics: a double-blind, randomised, placebo-controlled clinical trial.
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.
Berk
Michael
M
Department of Clinical and Biomedical Sciences: Barwon Health, The University of Melbourne, Geelong, Australia.
Gama
Clarissa S
CS
Sundram
Suresh
S
Hustig
Harry
H
Koopowitz
Les
L
D'Souza
Russell
R
Malloy
Hamish
H
Rowland
Cate
C
Monkhouse
Alison
A
Monkhouse
Andrew
A
Bole
Fiona
F
Sathiyamoorthy
Sumathy
S
Piskulic
Danijela
D
Dodd
Seetal
S