University of Melbourne, Department of Psychiatry, Austin Health, Heidelberg, VIC, Australia.
University of Melbourne, Department of Psychiatry, Austin Health, Heidelberg, VIC, Australia; University of Melbourne, Department of Psychiatry, The Melbourne Clinic, Richmond, VIC, Australia.
Psychiatry Res. 2023 Sep;327:115398. doi: 10.1016/j.psychres.2023.115398. Epub 2023 Jul 30.
PTSD may involve oxidative stress, and N-acetylcysteine (NAC) may reduce the impact of oxidative stress in the brain. This study aims to investigate the efficacy of adjuvant NAC in people with treatment-resistant PTSD.
A multicentre, randomised, double-blind, placebo-controlled trial for adults with PTSD unresponsive to first-line treatment. The intervention was either oral NAC 2.7 g/day or placebo for 12 weeks. The primary outcome was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 12 weeks compared with baseline. Secondary outcomes included depression and substance craving. Follow-up measures were obtained at 16 and 64-weeks.
133 patients were assessed, with 105 randomised; 81 participants completed the 12-week trial, 79 completed week-16 follow-up, and 21 completed week-64 follow-up. There were no significant differences between those taking NAC and those taking placebo in CAPS-5 scores at week 12, nor in secondary outcomes. Significant between-group differences were observed at week 64 in craving duration (Cohen's d = 1.61) and craving resistance (Cohen's d = 1.03), both in favour of NAC.
This was the first multicentre, double-blind, randomised, placebo-controlled trial of adjunctive NAC for treatment-resistant PTSD. No benefit of NAC was observed in this group beyond that provided by placebo at end of the trial.
ACTRN12618001784202, retrospectively registered 31/10/2018, URL: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376004.
创伤后应激障碍（PTSD）可能涉及氧化应激，而 N-乙酰半胱氨酸（NAC）可能减轻大脑中的氧化应激影响。本研究旨在探究辅助性 NAC 对治疗抵抗性 PTSD 患者的疗效。
这是一项针对对一线治疗无反应的 PTSD 成年患者的多中心、随机、双盲、安慰剂对照试验。干预措施为口服 NAC 2.7g/天或安慰剂，疗程为 12 周。主要结局为与基线相比，12 周时的 DSM-5 临床医生管理 PTSD 量表（CAPS-5）变化。次要结局包括抑郁和物质渴求。随访测量在 16 周和 64 周时进行。
共评估了 133 名患者，其中 105 名被随机分组；81 名参与者完成了 12 周试验，79 名参与者完成了 16 周随访，21 名参与者完成了 64 周随访。NAC 组和安慰剂组在 12 周时 CAPS-5 评分以及次要结局方面均无显著差异。在 64 周时，两组间的渴求持续时间（Cohen's d=1.61）和渴求抵抗（Cohen's d=1.03）存在显著差异，均有利于 NAC。
这是首例针对治疗抵抗性 PTSD 的辅助性 NAC 的多中心、双盲、随机、安慰剂对照试验。在试验结束时，NAC 并未观察到比安慰剂更能改善该组患者的获益。
ACTRN12618001784202，于 2018 年 10 月 31 日回溯注册，网址：http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376004。
