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

Article


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, Working group, Cadence 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. 20, pp. 1-4. https://doi.org/10.1186/s13063-019-3232-8
Article 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

ERA Journal ID35155
Article CategoryArticle
AuthorsLim, Carmen (Author), Baker, Andrea (Author), Saha, Sukanta (Author), Foley, Sharon (Author), Gordon, Anne (Author), Ward, David (Author), Burgher, Bjorn (Author), Dark, Frances (Author), Beckmann, Martin (Author), Stathis, Stephen (Author), Bruxner, George (Author), Ryan, Alex (Author), Richardson, Drew (Author), Hatherill, Sean (Author), Berk, Michael (Author), Dean, Olivia (Author), McGrath, John (Author), Working group, Cadence (Author) and Scott, James (Author)
Journal TitleTrials
Journal Citation20, pp. 1-4
Article Number203
Number of Pages4
Year2019
Place of PublicationUnited Kingdom
ISSN1745-6215
Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-019-3232-8
Web Address (URL)https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3232-8
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.

KeywordsStatistical analysis plan, Early psychosis, Randomized clinical trial, Sodium benzoate, PANSS, RCT
ANZSRC Field of Research 2020320221. Psychiatry (incl. psychotherapy)
Byline AffiliationsQueensland Centre for Mental Health Research, Australia
Department of Health, Queensland
Deakin University
Institution of OriginUniversity of Southern Queensland
Permalink -

https://research.usq.edu.au/item/q7v2y/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

  • 30
    total views
  • 20
    total downloads
  • 0
    views this month
  • 0
    downloads this month

Export as

Related outputs

Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services
Lu, Zhen Qi, de Geus, Hanna, Roest, Sanna, Payne, Leanne, Krishnamoorthy, Govind, Littlewood, Robyn, Hoyland, Margaret, Stathis, Stephen, Bor, William and Middeldorp, Christel. 2022. "Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services." Early Intervention in Psychiatry. 16 (12), pp. 1297-1308. https://doi.org/10.1111/eip.13275
Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX)
Siskind, Dan, Russell, A., Gamble, C., Baker, A., Cosgrove, P., Burton, L. and Kisely, S.. 2020. "Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX)." Journal of Psychiatric Research. 124, pp. 9-12. https://doi.org/10.1016/j.jpsychires.2020.02.015
Co‐morbidity between mood and anxiety disorders: A systematic review and meta‐analysis
Saha, Sukanta, Lim, Carmen C. W., Cannon, Danielle L., Burton, Lucinda, Bremner, Monique, Cosgrove, Peter, Yan, Huo and McGrath, John J.. 2020. "Co‐morbidity between mood and anxiety disorders: A systematic review and meta‐analysis." Depression and Anxiety. 38 (3), pp. 286-306. https://doi.org/10.1002/da.23113
Variation in the prevalence of different forms of bullying victimisation among adolescents and their associations with family, peer and school connectedness: a population-based study in 40 lower and middle income to high-income countries (LMIC-HICs)
Biswas, Tuhin, Thomas, Hannah J., Scott, James G., Munir, Kerim, Baxter, Janeen, Huda, M. Mamun, Renzaho, Andre M.N., Cross, Donna, Ahmed, Helal Uddin, Mahumud, Rashidul Alam and Al Mamun, Abdullah. 2022. "Variation in the prevalence of different forms of bullying victimisation among adolescents and their associations with family, peer and school connectedness: a population-based study in 40 lower and middle income to high-income countries (LMIC-HICs)." Journal of Child and Adolescent Trauma. 15 (4), pp. 1029-1039. https://doi.org/10.1007/s40653-022-00451-8
Deep learning for neuroimaging-based diagnosis and rehabilitation of Autism Spectrum Disorder: A review
Khodatars, Marjane, Shoeibi, Afshin, Sadeghi, Delaram, Ghassemi, Navid, Jafari, Mahboobeh, Moridian, Parisa, Khadem, Ali, Alizadehsani, Roohallah, Zare, Assef, Kong, Yinan, Khosravi, Abbas, Nahavandi, Saeid, Hussain, Sadiq, Acharya, U. Rajendra and Berk, Michael. 2021. "Deep learning for neuroimaging-based diagnosis and rehabilitation of Autism Spectrum Disorder: A review." Computers in Biology and Medicine. 139. https://doi.org/10.1016/j.compbiomed.2021.104949
Modelling human facial UV exposure
Downs, Nathan J., Kimlin, Michael G., Parisi, Alfio V. and McGrath, John J.. 2001. "Modelling human facial UV exposure." Radiation Protection in Australasia. 17 (3), pp. 103-109.
Evidence of altered prefrontal–thalamic circuitry in schizophrenia: An optimized diffusion MRI study
Rose, S., Chalk, J., Janke, A., Strudwick, M., Windus, Louisa C., Hannah, D., McGrath, J., Pantelis, C., Wood, S. and Mowry, B.. 2006. "Evidence of altered prefrontal–thalamic circuitry in schizophrenia: An optimized diffusion MRI study." NeuroImage. 32 (1), pp. 16-22. https://doi.org/10.1016/j.neuroimage.2006.03.003
Vitamin D Insufficiency In south-east Queensland
McGrath, John J., Kimlin, Michael G., Saha, Sukanta, Eyles, Darryl W. and Parisi, Alfio V.. 2001. "Vitamin D Insufficiency In south-east Queensland." Medical Journal of Australia. 174 (3), pp. 150-151. https://doi.org/10.5694/j.1326-5377.2001.tb143195.x
Neurogenesis in adult human
Murrell, Wayne, Ray-Barruel, Gillia, Livesey, Jonathon, McGrath, John, MacDonald, Kelli P. A., Bates, Paul R. and Mackay-Sim, Alan. 1996. "Neurogenesis in adult human ." NeuroReport. 7 (6), pp. 1189-1194. https://doi.org/10.1097/00001756-199604260-00019
Cell cycle characteristics and schizophrenia
Shepherd, R.A., Bates, P.R. and McGrath, J.J.. 1993. "Cell cycle characteristics and schizophrenia ." Biological Psychiatry. 33 (1), pp. 60-61. https://doi.org/10.1016/0006-3223(93)90282-I