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.

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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, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Dean, OliviaORCID iD for 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
Persistent URL http://hdl.handle.net/10536/DRO/DU:30120543

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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