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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial

Authors: Alex Ryan, Andrea Baker, Frances Dark, Sharon Foley, Anne Gordon, Sean Hatherill, Stephen Stathis, Sukanta Saha, George Bruxner, Martin Beckman, Drew Richardson, Michael Berk, Olivia Dean, John McGrath, Cadence Working Group, James Scott

Published in: Trials | Issue 1/2017

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Abstract

Background

Psychotic disorders affect up to 3% of the population and are often chronic and disabling. Innovation in the pharmacological treatment of psychosis has remained stagnant in recent decades. In order to improve outcomes for those with psychotic disorders, we present a protocol for the trial of a common food preservative, sodium benzoate, as an adjunctive treatment in early psychosis.

Methods

Persons experiencing early psychosis (n = 160) will be recruited through hospitals and community mental health services in Queensland, Australia. Patients will be randomized to receive either 12-week treatment with 1000 mg (500 mg twice daily (BD)) sodium benzoate or placebo. Patients will undergo fortnightly outcome assessments, in addition to weekly ongoing capacity to consent, drug compliance and safety assessments. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcomes are Global Assessment of Function (GAF), Assessment of Quality of Life Scale (AQOL), the Activity and Participation Questionnaire (APQ6), International Physical Activity Questionnaires (IPAQ), Simple Physical Activity Questionnaire (SIMPAQ), Physical Activity Questionnaire, Clinical Global Impression (CGI), Hamilton Depression rating Scale-17 items (HDRS), Opiate Treatment Index (OTI) and the Patients’ Global Impression of Improvement (PGI-I). As a tertiary objective, changes from baseline to endpoint in to serum markers related to D-alanine, L-alanine, D-serine, L-serine, glycine and glutamate will be investigated.

Discussion

Consumers and clinicians are keen to help develop better treatments for those with psychosis. This study, part of the wider Cadence clinical trials platform will examine if a safe and accessible food preservative can help optimize outcomes in those with psychosis.

Trial Registration

Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12615000187​549. Registered on 26 February 2015.
Appendix
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Metadata
Title
The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial
Authors
Alex Ryan
Andrea Baker
Frances Dark
Sharon Foley
Anne Gordon
Sean Hatherill
Stephen Stathis
Sukanta Saha
George Bruxner
Martin Beckman
Drew Richardson
Michael Berk
Olivia Dean
John McGrath
Cadence Working Group
James Scott
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1908-5

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