Department of Economics and Business Economics

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

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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; Scott, James.

In: Trials, Vol. 20, 203, 04.2019.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

Harvard

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

APA

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, 20, [203]. https://doi.org/10.1186/s13063-019-3232-8

CBE

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. 20:Article 203. https://doi.org/10.1186/s13063-019-3232-8

MLA

Vancouver

Author

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 ; Scott, James. / 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. In: Trials. 2019 ; Vol. 20.

Bibtex

@article{b0ab55245b6c47a591a7d0435ef7bccf,
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",
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.TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12615000187549 ). Registered on 26th February 2015.",
keywords = "Early psychosis, PANSS, RCT, Randomized clinical trial, Sodium benzoate, Statistical analysis plan",
author = "Carmen Lim and Andrea Baker and Sukanta Saha and Sharon Foley and Anne Gordon and David Ward and Bjorn Burgher and Frances Dark and Martin Beckmann and Stephen Stathis and George Bruxner and Alex Ryan and Drew Richardson and Sean Hatherill and Michael Berk and Olivia Dean and John McGrath and {Cadence Working Group} and James Scott",
year = "2019",
month = apr,
doi = "10.1186/s13063-019-3232-8",
language = "English",
volume = "20",
journal = "Current Controlled Trials in Cardiovascular Medicine (Print)",
issn = "1468-6708",
publisher = "BioMed Central Ltd.",

}

RIS

TY - JOUR

T1 - Protocol update and statistical analysis plan for CADENCE-BZ

T2 - a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

AU - Lim, Carmen

AU - Baker, Andrea

AU - Saha, Sukanta

AU - Foley, Sharon

AU - Gordon, Anne

AU - Ward, David

AU - Burgher, Bjorn

AU - Dark, Frances

AU - Beckmann, Martin

AU - Stathis, Stephen

AU - Bruxner, George

AU - Ryan, Alex

AU - Richardson, Drew

AU - Hatherill, Sean

AU - Berk, Michael

AU - Dean, Olivia

AU - McGrath, John

AU - Cadence Working Group

AU - Scott, James

PY - 2019/4

Y1 - 2019/4

N2 - 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.

AB - 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.

KW - Early psychosis

KW - PANSS

KW - RCT

KW - Randomized clinical trial

KW - Sodium benzoate

KW - Statistical analysis plan

UR - http://www.scopus.com/inward/record.url?scp=85064118833&partnerID=8YFLogxK

U2 - 10.1186/s13063-019-3232-8

DO - 10.1186/s13063-019-3232-8

M3 - Journal article

C2 - 30961658

VL - 20

JO - Current Controlled Trials in Cardiovascular Medicine (Print)

JF - Current Controlled Trials in Cardiovascular Medicine (Print)

SN - 1468-6708

M1 - 203

ER -