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N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms

Rossell, Susan L., Francis, Paul S., Galletly, Cherrie, Harris, Anthony, Siskind, Dan, Berk, Michael, Bozaoglu, Kiymet, Dark, Frances, Dean, Olivia, Liu, Dennis, Meyer, Denny, Neill, Erica, Phillipou, Andrea, Sarris, Jerome and Castle, David J. 2016, N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms, BMC psychiatry, vol. 16, no. 1, pp. 1-9, doi: 10.1186/s12888-016-1030-3.

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Title N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms
Author(s) Rossell, Susan L.
Francis, Paul S.ORCID iD for Francis, Paul S. orcid.org/0000-0003-4165-6922
Galletly, Cherrie
Harris, Anthony
Siskind, Dan
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Bozaoglu, Kiymet
Dark, Frances
Dean, OliviaORCID iD for Dean, Olivia orcid.org/0000-0002-2776-3935
Liu, Dennis
Meyer, Denny
Neill, Erica
Phillipou, Andrea
Sarris, Jerome
Castle, David J.
Journal name BMC psychiatry
Volume number 16
Issue number 1
Start page 1
End page 9
Total pages 9
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2016-09
ISSN 1471-244X
Keyword(s) Biomarkers
Clozapine
Cognition
N-Acetylcysteine
Negative Symptoms
Schizophrenia
Science & Technology
Life Sciences & Biomedicine
Psychiatry
Summary 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.
Language eng
DOI 10.1186/s12888-016-1030-3
Field of Research 110199 Medical Biochemistry and Metabolomics not elsewhere classified
110302 Clinical Chemistry (Diagnostics)
1103 Clinical Sciences
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Grant ID NHMRC APP1098442
Copyright notice ©2016, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30086396

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.