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Maintenance N-acetyl cysteine treatment for bipolar disorder : a double-blind randomised placebo controlled trial

Berk, Michael, Dean, Olivia M., Cotton, Sue M., Gama, Clarissa S., Kapczinski, Flavio, Fernandes, Brisa, Kohlmann, Kristy, Jeavons, Susan, Hewitt, Karen, Moss, Kirsteen, Allwang, Christine, Schapkaitz, Ian, Cobb, Heidi, Bush, Ashley I., Dodd, Seetal and Malhi, Gin S. 2012, Maintenance N-acetyl cysteine treatment for bipolar disorder : a double-blind randomised placebo controlled trial, BMC medicine, vol. 10, no. 91, pp. 1-11.

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Title Maintenance N-acetyl cysteine treatment for bipolar disorder : a double-blind randomised placebo controlled trial
Author(s) Berk, Michael
Dean, Olivia M.
Cotton, Sue M.
Gama, Clarissa S.
Kapczinski, Flavio
Fernandes, Brisa
Kohlmann, Kristy
Jeavons, Susan
Hewitt, Karen
Moss, Kirsteen
Allwang, Christine
Schapkaitz, Ian
Cobb, Heidi
Bush, Ashley I.
Dodd, Seetal
Malhi, Gin S.
Journal name BMC medicine
Volume number 10
Issue number 91
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, England
Publication date 2012
ISSN 1741-7015
Keyword(s) N-acetyl cysteine
depression
bipolar disorder
maintenance
mania
oxidative
Summary Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder.

Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of [greater than or equal to]12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes.

Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures.

Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).
Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Language eng
Field of Research 119999 Medical and Health Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, Berk et al.
Persistent URL http://hdl.handle.net/10536/DRO/DU:30047451

Document type: Journal Article
Collections: School of Medicine
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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.