Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

BMC Medicine

Gin S Malhi⁴  Seetal Dodd⁶  Ashley I Bush¹  Heidi Cobb⁴  Ian Schapkaitz¹  Christine Allwang⁴  Kirsteen Moss⁴  Karen Hewitt¹  Susan Jeavons¹  Kristy Kohlmann¹  Brisa Fernandes²  Flavio Kapczinski⁵  Clarissa S Gama⁵  Sue M Cotton³  Olivia M Dean⁶  Michael Berk⁶ 

[1] Mental Health Research Institute, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, 3052, Parkville, Australia;Laboratory of Calcium Binding Proteins in the Central Nervous System, Department of Biochemistry, Federal University of Rio Grande do Sul - UFRGS -, Porto Alegre, 90035-000, Brazil;Centre of Youth Mental Health, University of Melbourne, 35 Poplar Rd, Parkville, 3052, Australia;Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, 2006, Australia;Laboratory of Molecular Psychiatry, INCT for Translational Medicine, CNPq. Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, 90010-000, Brazil;University of Melbourne, Department of Psychiatry, Level 1 North, Main Block, Royal Melbourne Hospital, Parkville, 3052, Australia

关键词: oxidative;    mania;    maintenance;    bipolar disorder;    depression;    N-acetyl cysteine;   

Others  :  857371
DOI  :  10.1186/1741-7015-10-91

 received in 2012-05-07, accepted in 2012-08-14,  发布年份 2012

【 摘 要 】

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 ≥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).

【 授权许可】

   
2012 Berk et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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