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

Autor: Drew Richardson, Andrea Baker, James Scott, Sharon Foley, Bjorn Burgher, Anne Gordon, Carmen C.W. Lim, Olivia M Dean, Martin Beckmann, Michael Berk, David Ward, George Bruxner, Stephen Stathis, John J. McGrath, Sukanta Saha, Sean Hatherill, Frances Dark, Alex Ryan
Jazyk: angličtina
Rok vydání: 2019
Předmět:
PANSS
medicine.medical_specialty
Statistical analysis plan
Time Factors
Medicine (miscellaneous)
Update
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Statistical Analysis Plan
Randomized controlled trial
Double-Blind Method
law
Medicine
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Sodium benzoate
Randomized Controlled Trials as Topic
Protocol (science)
lcsh:R5-920
business.industry
Australia
3. Good health
Clinical trial
Treatment Outcome
chemistry
Psychotic Disorders
Sample size determination
Data Interpretation
Statistical
Sample Size
Adjunctive treatment
Early psychosis
Physical therapy
Randomized clinical trial
business
Cadence
lcsh:Medicine (General)
030217 neurology & neurosurgery
RCT
Antipsychotic Agents
Zdroj: Trials, Vol 20, Iss 1, Pp 1-4 (2019)
Trials
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
ISSN: 1745-6215
Popis: 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.
Databáze: OpenAIRE
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