Sodium benzoate as an adjunctive treatment in early psychosis: A randomised clinical trial

Abstract

Background: 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. Objectives: To examine the clinical efficacy of the adjunctive use of sodium benzoate for symptoms in participants with early psychosis Methods: Using a randomised, placebo-controlled doubleblind parallel-group design, this clinical trial was conducted from August 2015 to July 2018, data analyses were performed between November 2018 and February 2020. Participants aged between 18 and 60 years experiencing early psychosis were enrolled from five major clinical sites in Queensland, Australia. Findings: 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 = 0 .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: There is no evidence that adjunctive use of 500 mg of sodium benzoate twice daily is an effective treatment for individuals with early psychosis.L6351890842021-06-10 <br />