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
Randomized clinical trial
Statistical analysis plan
Trials, Vol 20, Iss 1, Pp 1-4 (2019)
Lim, C, Baker, A, Saha, S, Foley, S, Gordon, A, Ward, D, Burgher, B, Dark, F, Beckmann, M, Stathis, S, Bruxner, G, Ryan, A, Richardson, D, Hatherill, S, Berk, M, Dean, O, McGrath, J, Cadence Working Group & Scott, J 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, vol. 20, 203 . https://doi.org/10.1186/s13063-019-3232-8
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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.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12615000187549 ). Registered on 26th February 2015.
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