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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  • Carmen Lim, 1] The University of Queensland, Queensland Brain Institute, St Lucia, Queensland 4072, Australia. [2] QIMR Berghofer Medical Research Institute, Brisbane, Queensland 4006, Australia.
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  • Andrea Baker, Queensland Centre for Schizophrenia Mental Health Research, The Park, Centre for Mental Health, Wacol, Australia.
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  • Sukanta Saha, 1] The University of Queensland, Queensland Brain Institute, St Lucia, Queensland 4072, Australia. [2] QIMR Berghofer Medical Research Institute, Brisbane, Queensland 4006, Australia.
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  • Sharon Foley, Metro South Mental Health, 228 Logan Rd, Woolloongabba, QLD, 4102, Australia.
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  • Anne Gordon, Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia; School of Public Health, The University of Queensland, Herston, Australia; Metro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
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  • David Ward, Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia; School of Public Health, The University of Queensland, Herston, Australia; Metro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
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  • Bjorn Burgher, Metro North Mental Health Service, Prince Charles Hospital, Rode Rd, Chermside, 4032, QLD, Australia.
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  • Frances Dark, Metro South Mental Health, 228 Logan Rd, Woolloongabba, QLD, 4102, Australia.
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  • Martin Beckmann, Evolve Therapeutic Services Logan, Child and Youth Mental Health Services Logan, Academic Clinical Unit Logan, Metro South Hospital and Health Services, Logan, Australia.
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  • Stephen Stathis, Lady Cilento Children's Hospital, Raymond Terrace, South Brisbane, QLD, 4101, Australia.
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  • George Bruxner, Metro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, QLD, Australia.
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  • Alex Ryan, UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, QLD, 4029, Australia.
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  • Drew Richardson, Metro North Mental Health Service, Prince Charles Hospital, Rode Rd, Chermside, 4032, QLD, Australia.
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  • Sean Hatherill, Logan Hospital, Cnr Armstrong Rd and Loganlea Rd, Meadowbrook, QLD, 4131, Australia.
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  • Michael Berk, Department of Psychiatry, University of Melbourne, Level 1 North, Main Block, Royal Melbourne Hospital, Parkville, 3052, Australia.
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  • Olivia Dean, Department of Psychiatry, University of Melbourne, Level 1 North, Main Block, Royal Melbourne Hospital, Parkville, 3052, Australia.
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  • John McGrath
  • Cadence Working Group
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  • James Scott, The University of Queensland, UQ Centre for Clinical Research, Herston, Queensland 4029, Australia; Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD 4076, Australia; Metro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Queensland 4029, Australia. Electronic address: james.scott@health.qld.gov.au., UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, QLD, 4029, Australia. james.scott@health.qld.gov.au.

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.

Original languageEnglish
Article number203
JournalTrials
Volume20
ISSN1468-6708
DOIs
Publication statusPublished - Apr 2019

    Research areas

  • Early psychosis, PANSS, RCT, Randomized clinical trial, Sodium benzoate, Statistical analysis plan

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