Centre for Youth Mental Health - Research Publications

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Author: Berk, Michael × Author: Castle, David × Start date: 2018 × Type: Journal Article ×

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    N-Acetylcysteine (NAC) in Schizophrenia Resistant to Clozapine: A Double-Blind, Randomized, Placebo-Controlled Trial Targeting Negative Symptoms
    Neill, E ; Rossell, SL ; Yolland, C ; Meyer, D ; Galletly, C ; Harris, A ; Siskind, D ; Berk, M ; Bozaoglu, K ; Dark, F ; Dean, OM ; Francis, PS ; Liu, D ; Phillipou, A ; Sarris, J ; Castle, DJ (OXFORD UNIV PRESS, 2022-11-18)
    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).
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    The SMILES trial: an important first step
    Jacka, FN ; O'Neil, A ; Itsiopoulos, C ; Opie, R ; Cotton, S ; Mohebbi, M ; Castle, D ; Dash, S ; Mihalopoulos, C ; Chatterton, ML ; Brazionis, L ; Dean, OM ; Hodge, A ; Berk, M (BMC, 2018-12-28)
    The SMILES trial was the first intervention study to test dietary improvement as a treatment strategy for depression. Molendijk et al. propose that expectation bias and difficulties with blinding might account for the large effect size. While we acknowledge the issue of expectation bias in lifestyle intervention trials and indeed discuss this as a key limitation in our paper, we observed a strong correlation between dietary change and change in depression scores, which we argue is consistent with a causal effect and we believe unlikely to be an artefact of inadequate blinding. Since its publication, our results have been largely replicated and our recent economic evaluation of SMILES suggests that the benefits of our approach extend beyond depression. We argue that the SMILES trial should be considered an important, albeit preliminary, first step in the field of nutritional psychiatry research.