Effect of Sodium Benzoate vs Placebo Among Individuals With Early Psychosis: A Randomized Clinical Trial | Psychiatry | JAMA Network Open | JAMA Network
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    Original Investigation
    Psychiatry
    November 10, 2020

    Effect of Sodium Benzoate vs Placebo Among Individuals With Early Psychosis: A Randomized Clinical Trial

    Author Affiliations
    • 1Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia
    • 2QIMR Berghofer Medical Research Institute, Herston, Australia
    • 3Metro North Mental Health Service, Herston, Australia
    • 4Queensland Brain Institute, University of Queensland, St Lucia, Australia
    • 5Emotional Health Unit, Mater Hospital, South Brisbane, Australia
    • 6Metro South Mental Health, MacGregor, Australia
    • 7Metro North Mental Health, Royal Brisbane and Women’s Hospital, Herston, Australia
    • 8West Moreton Mental Health Service, Ipswich, Australia
    • 9Metro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, Australia
    • 10School of Medicine, Logan Hospital, Griffith University, Meadowbrook, Australia
    • 11Child and Youth Mental Health Service, Metro South Mental Health, Logan Hospital, Meadowbrook, Australia
    • 12Metro South Addiction and Mental Health Services, Logan Hospital, Meadowbrook, Australia
    • 13Queensland Children’s Hospital, South Brisbane, Australia
    • 14Child Health Research Centre, University of Queensland, Brisbane, Australia
    • 15Mental Health and Addiction Services, Sunshine Coast Hospital and Health Service, Birtinya, Australia
    • 16School of Medicine, Sunshine Coast University Hospital, Griffith University, Birtinya, Australia
    • 17University of Queensland Centre for Clinical Research, Herston, Australia
    • 18Department of Chemical Pathology, Pathology Queensland, Royal Brisbane and Women’s Hospital, Herston, Australia
    • 19Department of Chemical Pathology, Pathology Queensland, Brisbane, Australia
    • 20School of Biomedical Sciences, University of Queensland, St Lucia, Australia
    • 21Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Deakin University, Geelong, Australia
    • 22National Centre for Register-based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark
    JAMA Netw Open. 2020;3(11):e2024335. doi:10.1001/jamanetworkopen.2020.24335
    Key Points

    Question  Is 1000 mg of sodium benzoate daily an effective adjunctive treatment for early psychosis?

    Findings  In this randomized clinical trial of 100 participants with early psychosis, there was no significant improvement in the total Positive and Negative Syndrome Scale (PANSS) score for those who received 1000 mg of sodium benzoate for 12 weeks compared with those who received placebo. There were no end point differences in any subscales of the PANSS, any secondary clinical measures, nor any blood amino acid concentrations between treatment and placebo groups.

    Meaning  In this study, there was no evidence that adjunctive use of 1000 mg of sodium benzoate daily is an effective treatment for individuals with early psychosis.

    Abstract

    Importance  There is evidence that sodium benzoate (BZ) may be an effective adjunctive treatment for schizophrenia. The clinical efficacy of BZ has been investigated in chronic schizophrenia; however, the efficacy of this agent has not been studied in individuals with early psychosis.

    Objective  To examine the clinical efficacy of the adjunctive use of BZ for symptoms in people with early psychosis.

    Design, Setting, and Participants  Using a placebo-controlled double-masked parallel-group design, this randomized clinical trial was conducted from August 2015 to July 2018. Participants aged between 15 and 45 years experiencing early psychosis were enrolled from 5 major clinical sites in Queensland, Australia. Data analysis was conducted from October 2018 to February 2020.

    Interventions  Participants were randomized 1:1 (50 participants in each group) to receive 500 mg of sodium benzoate twice daily or placebo for 12 weeks.

    Main Outcomes and Measures  The primary efficacy outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks. The key secondary efficacy measures were (1) the Clinical Global Impression score, (2) the Hamilton Depression Rating Scale for depression, (3) functioning as assessed by the clinician-rated Global Assessment of Function, and (4) the Assessment of Quality of Life Scale. The PANSS subscale scores and impact on selected amino acid concentrations were also assessed.

    Results  The study comprised 100 participants with a mean (SD) age of 21.4 (4.1) years, of whom 73 (73%) were male individuals. The mean (SD) baseline PANSS score was 75.3 (15.4). We found no improvement in total PANSS score in the BZ group compared with the placebo group. The end result of least-squares mean difference (SE) for total PANSS was −1.2 (2.4) (P = .63). There were no differences in any subscales of the PANSS, any secondary measures, nor any amino acid concentrations. The dose of BZ was well tolerated without any clinically significant treatment-emergent adverse event differences between BZ and placebo groups.

    Conclusions and Relevance  In this randomized clinical trial, there was no evidence that adjunctive use of 500 mg of BZ twice daily is an effective treatment for individuals with early psychosis.

    Trial Registration  anzctr.org.au Identifier: ACTRN12615000187549

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