Evidence map›Paper›PMID 34903265›Full record

ArticleTrials2021

Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia.

Andrea Baker, Lachlan Clarke, Peter Donovan, Jacobus P J Ungerer, Gunter Hartel, George Bruxner, Luca Cocchi, Anne Gordon, Vikas Moudgil, Gail Robinson and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Review
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

14 authors at 5 institutions in 1 country.

Andrea BakerQIMR Berghofer Medical Research Institute, Herston, QLD, Australia.
Lachlan ClarkeQIMR Berghofer Medical Research Institute, Herston, QLD, Australia.
Peter DonovanFaculty of Medicine, The University of Queensland, Herston, QLD, Australia.
Jacobus P J UngererSchool of Biomedical Sciences, The University of Queensland, Herston, QLD, Australia.
Gunter HartelQIMR Berghofer Medical Research Institute, Herston, QLD, Australia.
George BruxnerMetro North Mental Health Service, Caboolture Hospital, Caboolture, QLD, Australia.
Luca CocchiQIMR Berghofer Medical Research Institute, Herston, QLD, Australia.
Anne GordonMetro North Mental Health Service, The Prince Charles Hospital, Chermside, QLD, Australia.
Vikas MoudgilMetro North Mental Health Service, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
Gail RobinsonFaculty of Medicine, The University of Queensland, Herston, QLD, Australia.
Digant RoyMetro North Mental Health Service, The Prince Charles Hospital, Chermside, QLD, Australia.
Ravinder SohalMetro North Mental Health Service, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
Emma WhittleClinical Pharmacology, Royal Brisbane and Women's Hospital, Herston, QLD, 4006, Australia.
James G ScottQIMR Berghofer Medical Research Institute, Herston, QLD, Australia. james.scott@qimrberghofer.edu.au.ORCID http://orcid.org/0000-0002-0744-0688
The University of Queensland · AUQIMR Berghofer Medical Research Institute · AURoyal Brisbane and Women's Hospital · AUPrince Charles Hospital · AUMetro South Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSchizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative holds potential to be an effective, accessible treatment for schizophrenia, though the optimal dosing and mechanism of action of the compound requires further investigation.

methodsIndividuals with persistent treatment-refractory schizophrenia (n=52) will be recruited. Patients will be randomised in a 1:1:1:1 ratio to receive treatment of one of three active doses (1000, 2000 or 4000 mg daily) of sodium benzoate or placebo for 6 weeks duration. The primary outcome measurement is change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcome measurements are PANSS subscales, Global Assessment of Function (GAF), Clinical Global Impression (CGI) and Patient Global Impression (PGI-I). Change in concentrations of peripheral amino acids (D-alanine, L-alanine, D-serine, L-serine, glycine and glutamate), plasma sodium benzoate, plasma catalase, 3-nitrotyrosine, malondialdehyde and high-sensitivity C-reactive protein (hs-CRP) will be determined as tertiary measures. DISCUSSION: This trial seeks to build upon previous research indicating potential efficacy of sodium benzoate for reduction of symptoms in individuals with treatment-refractory schizophrenia. The trial aims to improve the understanding of the mechanism of action of the compound.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000327886 . Registered on 23 March 2021.

Indexed as

Antipsychotic AgentsSchizophreniaAustraliaDouble-Blind MethodHumansSchizophrenia, Treatment-ResistantSodium BenzoateTreatment OutcomeAntipsychotic AgentsSodium BenzoateAdjunctiveClinical trialInterventionPANSSRCTSchizophreniaSodium benzoateTreatment refractory

Identifiers

PMID34903265
PMCPMC8670031
OpenAlexW4200425878

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.