Evidence map›Paper›PMID 30961658›Full record

ArticleTrials2019

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.

Carmen Lim, Andrea Baker, Sukanta Saha, Sharon Foley, Anne Gordon, David Ward, Bjorn Burgher, Frances Dark, Martin Beckmann, Stephen Stathis and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 2 countries.

Carmen LimQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Andrea BakerQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Sukanta SahaQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Sharon FoleyMetro South Mental Health, 228 Logan Rd, Woolloongabba, QLD, 4102, Australia.
Anne GordonMetro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
David WardMetro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
Bjorn BurgherMetro North Mental Health Service, Prince Charles Hospital, Rode Rd, Chermside, 4032, QLD, Australia.
Frances DarkMetro South Mental Health, 228 Logan Rd, Woolloongabba, QLD, 4102, Australia.
Martin BeckmannEvolve Therapeutic Services Logan, Child and Youth Mental Health Services Logan, Academic Clinical Unit Logan, Metro South Hospital and Health Services, Logan, Australia.
Stephen StathisLady Cilento Children's Hospital, Raymond Terrace, South Brisbane, QLD, 4101, Australia.
George BruxnerMetro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, QLD, Australia.
Alex RyanQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Drew RichardsonMetro North Mental Health Service, Prince Charles Hospital, Rode Rd, Chermside, 4032, QLD, Australia.
Sean HatherillLogan Hospital, Cnr Armstrong Rd and Loganlea Rd, Meadowbrook, QLD, 4131, Australia.
Michael BerkIMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon Health, P.O. Box 291, Geelong, 3220, Australia.
Olivia DeanIMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon Health, P.O. Box 291, Geelong, 3220, Australia.
John McGrathQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Cadence Working Group
James ScottQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia. james.scott@health.qld.gov.au.ORCID http://orcid.org/0000-0002-0744-0688
The University of Queensland · AULogan Hospital · AURoyal Brisbane and Women's Hospital · AUPark Centre for Mental Health · AUThe Royal Melbourne Hospital · AUBarwon Health · AUMetro South Health · AURedcliffe Hospital · AU

Funding

National Health and Medical Research Council 1059660National Health and Medical Research Council 1156072National Health and Medical Research Council APP1056929National Health and Medical Research Council Practitioner Fellowship APP1105807
6 · The paper itself

Abstract

backgroundCADENCE-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.

conclusionsWe 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 registrationAustralian New Zealand Clinical Trials Registry ( ACTRN12615000187549 ). Registered on 26th February 2015.

Indexed as

Antipsychotic AgentsAustraliaData Interpretation, StatisticalDouble-Blind MethodHumansMulticenter Studies as TopicPsychotic DisordersRandomized Controlled Trials as TopicSample SizeSodium BenzoateTime FactorsTreatment OutcomeAntipsychotic AgentsSodium BenzoateEarly psychosisPANSSRandomized clinical trialRCTSodium benzoateStatistical analysis plan

Identifiers

PMID30961658
PMCPMC6454685
OpenAlexW2944797266

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.