Journal article

N-acetyl cysteine as a glutathione precursor for schizophrenia - A double-blind, randomized, placebo-controlled trial

Michael Berk, David Copolov, Olivia Dean, Kristy Lu, Sue Jeavons, Ian Schapkaitz, Murray Anderson-Hunt, Fiona Judd, Fiona Katz, Paul Katz, Sean Ording-Jespersen, John Little, Philippe Conus, Michel Cuenod, Kim Q Do, Ashley I Bush



BACKGROUND: Brain glutathione levels are decreased in schizophrenia, a disorder that often is chronic and refractory to treatment. N-acetyl cysteine (NAC) increases brain glutathione in rodents. This study was conducted to evaluate the safety and effectiveness of oral NAC (1 g orally twice daily [b.i.d.]) as an add-on to maintenance medication for the treatment of chronic schizophrenia over a 24-week period. METHODS: A randomized, multicenter, double-blind, placebo-controlled study. The primary readout was change from baseline on the Positive and Negative Symptoms Scale (PANSS) and its components. Secondary readouts included the Clinical Global Impression (CGI) Severity and Improvement scale..

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Funding Acknowledgements

This study was supported by a grant from the Stanley Medical Research Institue. AIB is supported by the Australian Research Council Federation Fellowship, The Woods Family Foundation. and the National Health and Medical Research Council of Australia supported OD. The Loterie Romande supported the Lausanne-Switzerland Center (grant to KQD).Trial registration: Australian Clinical Trials Registry, Protocol 12605000363684, thank Erihana Ryan, Warrick? Brewer, Patricia Deppen. Alexandra Solida, and Pierre Bovel for their assistance with this Project.Dr Berk has received grant or research support from the Stanley Medical Research Foundation. The MBF Foundation. National Health and Medical Research Council of Australia. Beyond Blue. Geelong, Medical Research Foundation, Bristol Squibb, Eli Lilly, Glaxo SmithKline, Organon, Novartis. Mayne Pharma, and Servier, is a consultant to Astra Zeneca. Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Janssen Cilag. Lundbeck, and Pfizer, and has been a speaker for Eli Lilly, Glaxo SmithKline, Janssen Cilag, Lundbeck? Organon, Pfizer. Sanofi Synthelabo. Solvay, and Wyeth. Dr. Bush is a shareholder and consultant for Prana Biotechnology Ltd and a shareholder of Cogstate Ltd. All other authors reported no biomedical financial interests or potential conflicts of interest.