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 Author(s) 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 orcid.org/0000-0002-5554-6946 Dean, Olivia orcid.org/0000-0002-2776-3935 McGrath, John Cadence Working Group Scott, James Journal name Trials Volume number 20 Issue number 1 Article ID 203 Total pages 4 Publisher BioMed Central Place of publication London, Eng. Publication date 2019-04-08 ISSN 1745-6215 Keyword(s) Early psychosis PANSS RCT Randomized clinical trial Sodium benzoate Statistical analysis plan Cadence Working Group Science & Technology Life Sciences & Biomedicine Medicine, Research & Experimental Research & Experimental Medicine Summary 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. Language eng DOI 10.1186/s13063-019-3232-8 Field of Research 1102 Cardiorespiratory Medicine and Haematology 1103 Clinical Sciences HERDC Research category C1 Refereed article in a scholarly journal Copyright notice ©2019, The Authors Free to Read? Yes Persistent URL http://hdl.handle.net/10536/DRO/DU:30120543 Document type: Journal Article Collections: Faculty of Health School of Medicine Open Access Collection Related Links Link Description Link to full-text (open access)   Connect to published version Go to link with your DU access privileges     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. Versions Version Filter Type Thu, 11 Apr 2019, 09:09:32 EST Fri, 12 Apr 2019, 05:00:55 EST Sat, 04 May 2019, 02:30:56 EST Sat, 04 May 2019, 02:33:28 EST Fri, 07 Jun 2019, 06:04:31 EST Mon, 24 Jun 2019, 11:44:18 EST Mon, 24 Jun 2019, 11:47:48 EST Fri, 15 Nov 2019, 05:36:54 EST Filtered Full Citation counts:   Cited 2 times in TR Web of Science Cited 1 times in Scopus Search Google Scholar Access Statistics: 278 Abstract Views, 0 File Downloads  -  Detailed Statistics Created: Thu, 11 Apr 2019, 09:09:32 EST

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.