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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 BMC+Psychiatry
2016 ; 16
(1
): 320
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N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind
randomised placebo controlled trial targeting negative symptoms
#MMPMID27629871
Rossell SL
; Francis PS
; Galletly C
; Harris A
; Siskind D
; Berk M
; Bozaoglu K
; Dark F
; Dean O
; Liu D
; Meyer D
; Neill E
; Phillipou A
; Sarris J
; Castle DJ
BMC Psychiatry
2016[Sep]; 16
(1
): 320
PMID27629871
show ga
BACKGROUND: Clozapine is an effective treatment for a proportion of people with
schizophrenia (SZ) who are resistant to the beneficial effects of other
antipsychotic drugs. However, anything from 40-60 % of people on clozapine
experience residual symptoms even on adequate doses of the medication, and thus
could be considered 'clozapine resistant'. Agents that could work alongside
clozapine to improve efficacy whilst not increasing the adverse effect burden are
both desired and necessary to improve the lives of individuals with
clozapine-resistant SZ. N-Acetylcysteine (NAC) is one such possible agent.
Previous research from our research group provided promising pilot data
suggesting the efficacy of NAC in this patient population. The aim of the study
reported here is to expand this work by conducting a large scale clinical trial
of NAC in the treatment of clozapine-resistant SZ. METHODS: This study is an
investigator initiated, multi-site, randomised, placebo-controlled trial. It aims
to include 168 patients with clozapine-resistant SZ, divided into an intervention
group (NAC) and a control group (placebo). Participants in the intervention group
will receive 2 g daily of NAC. The primary outcome measures will be the negative
symptom scores of the Positive and Negative Syndrome Scale (PANSS). Secondary
outcome measures will include: changes in quality of life (QoL) as measured by
the Lancashire Quality of Life Profile (LQoLP) and cognitive functioning as
measured by the total score on the MATRICS. Additionally we will examine
peripheral and cortical glutathione (GSH) concentrations as process outcomes.
DISCUSSION: This large scale clinical trial will investigate the efficacy of NAC
as an adjunctive medication to clozapine. This trial, if successful, will
establish a cheap, safe and easy-to-use agent (NAC) as a 'go to' adjunct in
patients that are only partly responsive to clozapine. TRIAL REGISTRATION:
Australian and New Zealand Clinical Trials Registration Number: Current
Randomised Controlled Trial ACTRN12615001273572 . The date of registration 23
November 2015.