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
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, Cadence Working Group 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, vol. 20, no. 1, doi: 10.1186/s13063-019-3232-8.
Attached Files
Name
Description
MIMEType
Size
Downloads
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
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.
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.
Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO.
If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.
Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.