Maintenance N-acetyl cysteine treatment for bipolar disorder: a double-blind randomized placebo controlled trial.
Maintenance N-acetyl cysteine treatment for bipolar disorder: a double-blind randomized placebo controlled trial.
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DOI：
10.1186/1741-7015-10-91
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发表时间：
2012-08-14
期刊：
影响因子：
9.3
通讯作者：
Malhi GS
中科院分区：
文献类型：
--
作者：
Berk M;Dean OM;Cotton SM;Gama CS;Kapczinski F;Fernandes B;Kohlmann K;Jeavons S;Hewitt K;Moss K;Allwang C;Schapkaitz I;Cobb H;Bush AI;Dodd S;Malhi GS
n -乙酰半胱氨酸（NAC）是一种谷胱甘肽前体，在安慰剂对照试验中已被证明具有抗抑郁功效。目前的研究旨在调查NAC在双相情感障碍开放标签治疗8周后的维持效果。在一项双盲随机安慰剂对照试验中，研究了2g /d NAC作为双相情感障碍辅助维持治疗的疗效。受试者（n = 149）在试验开始时的Montgomery Asberg抑郁评分≥12，在接受开放标签NAC治疗8周后，除常规治疗外，随机分为辅助NAC组或安慰剂组。参与者（主要是门诊病人）是通过公共和私人服务以及报纸广告招募的。情绪发作的干预时间是研究的主要终点，情绪症状、功能和生活质量的变化是次要终点。在为期八周的开放标签NAC治疗阶段，症状显著减少。在随后的双盲阶段，结果测量的进一步变化很小，得分仍然很低。因此，从这个低平台期开始，组间在复发、临床功能或生活质量测量方面没有出现差异。在试验的维持阶段，两组之间在复发或症状结局方面没有显著差异；然而，这些发现可能会受到局限性的影响。该试验已在澳大利亚新西兰临床试验登记处注册（ACTRN12607000074493）。
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. 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. 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. 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. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).
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影响因子：
--
作者：
Gueorguieva, R;Krystal, JH
通讯作者：
Krystal, JH
影响因子：
2.5
作者：
Dean, Olivia M.;van den Buuse, Maarten;Bush, Ashley I.
通讯作者：
Bush, Ashley I.
影响因子：
6.1
作者：
Efrati, S;Averbukh, M;Averbukh, Z
通讯作者：
Averbukh, Z
影响因子：
10.6
作者：
Grant, Jon E.;Kim, Suck Won;Odlaug, Brian L.
通讯作者：
Odlaug, Brian L.
DOI：
10.1006/bbrc.1995.1980
发表时间：
1995-07-17
影响因子：
3.1
作者：
DAS, I;KHAN, NS;HIRSCH, SR
通讯作者：
HIRSCH, SR