N-Acetylcysteine (NAC) in Schizophrenia Resistant to Clozapine: A Double-Blind, Randomized, Placebo-Controlled Trial Targeting Negative Symptoms,Schizophrenia Bulletin

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N-Acetylcysteine (NAC) in Schizophrenia Resistant to Clozapine: A Double-Blind, Randomized, Placebo-Controlled Trial Targeting Negative Symptoms
Schizophrenia Bulletin ( IF 6.6 ) Pub Date : 2022-07-20 , DOI: 10.1093/schbul/sbac065
Erica Neill _{1,

2,

3} , Susan L Rossell _{1,

2} , Caitlin Yolland _{1,

2} , Denny Meyer ₁ , Cherrie Galletly _{4,

5,

6} , Anthony Harris _{7,

8} , Dan Siskind _{9,

10} , Michael Berk _{11,

12,

13} , Kiymet Bozaoglu _{14,

15} , Frances Dark _{9,

10} , Olivia M Dean _{11,

12} , Paul S Francis ₁₆ , Dennis Liu _{4,

6} , Andrea Phillipou ₁ , Jerome Sarris _{12,

17,

18} , David J Castle _{1,

2,

3}

Affiliation

Centre for Mental Health, Faculty of Health, Arts & Design, Swinburne University of Technology, Melbourne, Australia.
Department of Mental Health, St Vincent's Hospital, Melbourne, Australia.
Department of Psychiatry, University of Melbourne, Melbourne, Australia.
Department of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.
Ramsay Health Care (SA) Mental Health, Adelaide, Australia.
Northern Adelaide Local Health Network, Adelaide, Australia.
Specialty of Psychiatry, Sydney Medical School, University of Sydney, Sydney, Australia.
Westmead Institute for Medical Research, Westmead, NSW 2145, Australia.
Metro South Addiction and Mental Health Service, Brisbane, Australia.
UQ School of Clinical Medicine, Brisbane, Australia.
Deakin University, IMPACT-the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, Melbourne, Australia.
Florey Institute for Neuroscience and Mental Health and the Department of Psychiatry, The University of Melbourne, Melbourne, Australia.
Department of Paediatrics, The University of Melbourne, Melbourne, Australia.
Bruce Lefroy Centre for Genetic Health Research, Murdoch Children's Research Institute, Melbourne, Australia.
School of Life and Environmental Sciences, Faculty of Science, Engineering and Built Environment, Deakin University, Waurn Ponds, VIC, Australia.
NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia.
Professional Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.

Background and Hypothesis Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, yet a significant proportion of individuals on clozapine continue to experience disabling symptoms, despite being treated with an adequate dose. There is a need for adjunct treatments to augment clozapine, notably for negative and cognitive symptoms. One such potential agent is the glutathione precursor N-acetylcysteine (NAC). Study Design A randomized double-blind, multi-center, placebo-controlled trial for clozapine patients with enduring psychotic symptoms (n = 84) was undertaken to investigate the efficacy of adjunctive NAC (2 g daily) for negative symptoms, cognition and quality of life (QoL). Efficacy was assessed at 8, 24, and 52 weeks. Study Results NAC did not significantly improve negative symptoms (P = .62), overall cognition (P = .71) or quality of life (Manchester quality of life: P = .11; Assessment of quality of life: P = .57) at any time point over a 1-year period of treatment. There were no differences in reported side effects between the groups (P = .26). Conclusions NAC did not significantly improve schizophrenia symptoms, cognition, or quality of life in treatment-resistant patients taking clozapine. This trial was registered with “Australian and New Zealand Clinical Trials” on the 30 May, 2016 (Registration Number: ACTRN12615001273572).

中文翻译：

N-乙酰半胱氨酸 (NAC) 治疗对氯氮平耐药的精神分裂症：针对阴性症状的双盲、随机、安慰剂对照试验

背景和假设氯氮平是治疗难治性精神分裂症最有效的抗精神病药物，但尽管接受了足够剂量的治疗，仍有很大一部分服用氯氮平的个体继续出现致残症状。需要辅助治疗来增强氯氮平，特别是针对阴性和认知症状。一种这样的潜在药物是谷胱甘肽前体 N-乙酰半胱氨酸 (NAC)。研究设计一项针对具有持久精神病症状的氯氮平患者 (n = 84) 进行的随机双盲、多中心、安慰剂对照试验，旨在研究辅助 NAC（每天 2 克）对阴性症状、认知和治疗质量的疗效。生活（生活质量）。在第 8、24 和 52 周评估疗效。研究结果 NAC 没有显着改善阴性症状 (P = .62)，在一年治疗期间的任何时间点，整体认知 (P = .71) 或生活质量（曼彻斯特生活质量：P = .11；生活质量评估：P = .57）。组间报告的副作用没有差异 (P = .26)。结论 NAC 并未显着改善服用氯氮平的治疗耐药患者的精神分裂症症状、认知或生活质量。本试验于2016年5月30日在“澳大利亚和新西兰临床试验”注册（注册号：ACTRN12615001273572）。服用氯氮平的难治性患者的认知或生活质量。本试验于2016年5月30日在“澳大利亚和新西兰临床试验”注册（注册号：ACTRN12615001273572）。服用氯氮平的难治性患者的认知或生活质量。本试验于2016年5月30日在“澳大利亚和新西兰临床试验”注册（注册号：ACTRN12615001273572）。

更新日期：2022-07-20

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