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

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 Open Access Collection

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