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

Ryan, Alex, Baker, Andrea, Dark, Frances, Foley, Sharon, Gordon, Anne, Hatherill, Sean, Stathis, Stephen, Saha, Sukanta, Bruxner, George, Beckman, Martin, Richardson, Drew, Berk, Michael, Dean, Olivia, McGrath, John and Scott, James (2017) The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial. Trials, 18 1: . doi:10.1186/s13063-017-1908-5


Author Ryan, Alex
Baker, Andrea
Dark, Frances
Foley, Sharon
Gordon, Anne
Hatherill, Sean
Stathis, Stephen
Saha, Sukanta
Bruxner, George
Beckman, Martin
Richardson, Drew
Berk, Michael
Dean, Olivia
McGrath, John
Scott, James
Title The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
1468-6708
Publication date 2017-04-07
Sub-type Article (original research)
DOI 10.1186/s13063-017-1908-5
Open Access Status DOI
Volume 18
Issue 1
Total pages 11
Place of publication London, United Kingdom
Publisher BioMed Central
Language eng
Formatted 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 1000mg (500mg 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.
Keyword Adjuvant
Clinical trial
Early psychosis
Intervention
PANSS
RCT
Schizophrenia
Sodium benzoate
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

 
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