Dataset Information

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

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.

SUBMITTER: Scott JG

PROVIDER: S-EPMC7656289 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Scott James G JG Baker Andrea A Lim Carmen C W CCW Foley Sharon S Dark Frances F Gordon Anne A Ward David D Richardson Drew D Bruxner George G Beckmann K Martin KM Hatherill Sean S Stathis Stephen S Dixon Krystal K Ryan Alexander E AE McWhinney Brett C BC Ungerer Jacobus P J JPJ Berk Michael M Dean Olivia M OM Saha Sukanta S McGrath John J

JAMA network open 20201102 11

<h4>Importance</h4>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.<h4>Objective</h4>To examine the clinical efficacy of the adjunctive use of BZ for symptoms in people with early psychosis.<h4>Design, setting, and participants</h4>Using a placebo-controlled double-masked pa ...[more]

PMID: 33170261

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Dataset Information

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

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

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

Similar Datasets

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