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

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Version 2 2024-06-06, 01:52
Version 1 2017-05-11, 15:20
journal contribution
posted on 2024-06-06, 01:52 authored by A Ryan, A Baker, F Dark, S Foley, A Gordon, S Hatherill, S Stathis, S Saha, G Bruxner, M Beckman, D Richardson, Michael BerkMichael Berk, Olivia DeanOlivia Dean, J McGrath, CW Group, J Scott
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), ACTRN12615000187549 . Registered on 26 February 2015.

History

Journal

Trials

Volume

18

Article number

ARTN 165

Pagination

1 - 11

Location

England

ISSN

1745-6215

eISSN

1745-6215

Language

English

Publication classification

C Journal article, C1 Refereed article in a scholarly journal

Copyright notice

2017, The Author(s)

Issue

1

Publisher

BIOMED CENTRAL LTD