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, doi: 10.1186/1741-7015-10-91. Attached Files Name Description MIMEType Size Downloads dodd-maintenance-2012.pdf Published version application/pdf 434.94KB 339 Title Maintenance N-acetyl cysteine treatment for bipolar disorder : a double-blind randomised placebo controlled trial Author(s) Berk, Michael orcid.org/0000-0002-5554-6946 Dean, Olivia M. orcid.org/0000-0002-2776-3935 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 orcid.org/0000-0002-7918-4636 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 DOI 10.1186/1741-7015-10-91 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. Free to Read? 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