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

BMC Medicine

Research Article

Olivia M Dean¹  Michael Berk²  Seetal Dodd³  Heidi Cobb⁴  Kirsteen Moss⁵  Christine Allwang⁶  Gin S Malhi⁷  Clarissa S Gama⁸  Flavio Kapczinski⁸  Karen Hewitt⁹  Ashley I Bush⁹  Susan Jeavons⁹  Kristy Kohlmann⁹  Ian Schapkaitz⁹  Sue M Cotton^1,10  Brisa Fernandes^1,11 

[1] Deakin University, School of Medicine, Barwon Health, P.O. Box 291, 3220, Geelong, Australia;Mental Health Research Institute, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, 3052, Parkville, Australia;University of Melbourne, Department of Psychiatry, Level 1 North, Main Block, Royal Melbourne Hospital, 3052, Parkville, Australia;Deakin University, School of Medicine, Barwon Health, P.O. Box 291, 3220, Geelong, Australia;Orygen Youth Health Research Centre, 35 Poplar Rd, 3052, Parkville, Australia;Centre of Youth Mental Health, University of Melbourne, 35 Poplar Rd, 3052, Parkville, Australia;Mental Health Research Institute, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, 3052, Parkville, Australia;University of Melbourne, Department of Psychiatry, Level 1 North, Main Block, Royal Melbourne Hospital, 3052, Parkville, Australia;Deakin University, School of Medicine, Barwon Health, P.O. Box 291, 3220, Geelong, Australia;University of Melbourne, Department of Psychiatry, Level 1 North, Main Block, Royal Melbourne Hospital, 3052, Parkville, Australia;Discipline of Psychiatry, Sydney Medical School, University of Sydney, 2006, Sydney, Australia;Discipline of Psychiatry, Sydney Medical School, University of Sydney, 2006, Sydney, Australia;CADE Clinic, Department of Psychiatry, Level 5 Building 36 Royal North Shore Hospital, 2065, St. Leonards, Australia;Discipline of Psychiatry, Sydney Medical School, University of Sydney, 2006, Sydney, Australia;CADE Clinic, Department of Psychiatry, Level 5 Building 36 Royal North Shore Hospital, 2065, St. Leonards, Australia;Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar der TU, München, Ismaninger Str. 22, 81675, Münich, Germany;Laboratory of Calcium Binding Proteins in the Central Nervous System, Department of Biochemistry, Federal University of Rio Grande do Sul - UFRGS -, 90035-000, Porto Alegre, Brazil;Discipline of Psychiatry, Sydney Medical School, University of Sydney, 2006, Sydney, Australia;Laboratory of Molecular Psychiatry, INCT for Translational Medicine, CNPq. Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, 90010-000, Porto Alegre, Brazil;Mental Health Research Institute, University of Melbourne, Kenneth Myer Building, 30 Royal Parade, 3052, Parkville, Australia;Orygen Youth Health Research Centre, 35 Poplar Rd, 3052, Parkville, Australia;Centre of Youth Mental Health, University of Melbourne, 35 Poplar Rd, 3052, Parkville, Australia;Post-graduate Program in Biological Sciences: Biochemistry, Federal University of Rio Grande do Sul - UFRGS -, 90035-000, Porto Alegre, Brazil;Laboratory of Calcium Binding Proteins in the Central Nervous System, Department of Biochemistry, Federal University of Rio Grande do Sul - UFRGS -, 90035-000, Porto Alegre, Brazil;

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

DOI  :  10.1186/1741-7015-10-91

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

来源: Springer

【 摘 要 】

BackgroundN-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.MethodThe 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.ResultsThere 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.ConclusionsThere 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 RegistrationThe trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).

【 授权许可】

CC BY   
© Berk et al; licensee BioMed Central Ltd. 2012