Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

Article

Lim, Carmen, Baker, Andrea, Saha, Sukanta, Foley, Sharon, Gordon, Anne, Ward, David, Burgher, Bjorn, Dark, Frances, Beckmann, Martin, Stathis, Stephen, Bruxner, George, Ryan, Alex, Richardson, Drew, Hatherill, Sean, Berk, Michael, Dean, Olivia, McGrath, John, Working group, Cadence and Scott, James. 2019. "Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis." Trials. 20, pp. 1-4. https://doi.org/10.1186/s13063-019-3232-8
Article Title

Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

ERA Journal ID35155
Article CategoryArticle
AuthorsLim, Carmen (Author), Baker, Andrea (Author), Saha, Sukanta (Author), Foley, Sharon (Author), Gordon, Anne (Author), Ward, David (Author), Burgher, Bjorn (Author), Dark, Frances (Author), Beckmann, Martin (Author), Stathis, Stephen (Author), Bruxner, George (Author), Ryan, Alex (Author), Richardson, Drew (Author), Hatherill, Sean (Author), Berk, Michael (Author), Dean, Olivia (Author), McGrath, John (Author), Working group, Cadence (Author) and Scott, James (Author)
Journal TitleTrials
Journal Citation20, pp. 1-4
Article Number203
Number of Pages4
Year2019
Place of PublicationUnited Kingdom
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-019-3232-8
Web Address (URL)https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3232-8
Abstract

Background: CADENCE-BZ is a multi-centre, parallel-group, double-blind randomized controlled trial designed to examine the clinical efficacy and safety of an accessible food preservative, sodium benzoate, as an add-on treatment for patients with early psychosis. The original study protocol was published in 2017. Here, we describe the updated protocol along with the Statistical Analysis Plan (SAP) for the CADENCE-BZ trial prior to study completion. Methods and materials: Two important changes were made to the original protocol: (1) improvements to our statistical analysis plan permitted a reduction in sample size; and (2) a revision in the secondary outcomes with the intent of reducing redundancy and excluding those measures that were not appropriate as outcomes. Conclusions: We provide the updated SAP prior to the completion of the study with the intent of increasing the transparency of the data analyses for CADENCE-BZ. The final participants are currently completing the study and the results will be published in the near future.

KeywordsStatistical analysis plan, Early psychosis, Randomized clinical trial, Sodium benzoate, PANSS, RCT
ANZSRC Field of Research 2020320221. Psychiatry (incl. psychotherapy)
Byline AffiliationsQueensland Centre for Mental Health Research, Australia
Department of Health, Queensland
Deakin University
Institution of OriginUniversity of Southern Queensland
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