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, Cadence Working Group 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, vol. 18, pp. 1-11, doi: 10.1186/s13063-017-1908-5. Attached Files Name Description MIMEType Size Downloads berk-efficacyofsodium-2017.pdf Published version application/pdf 835.44KB 68 Title The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - Cadence-BZ: study protocol for a randomized controlled trial Author(s) Ryan, Alex Baker, Andrea Dark, Frances Foley, Sharon Gordon, Anne Hatherill, Sean Stathis, Stephen Saha, Sukanta Bruxner, George Beckman, Martin Richardson, Drew Berk, Michael orcid.org/0000-0002-5554-6946 Dean, Olivia orcid.org/0000-0002-2776-3935 McGrath, John Cadence Working Group Scott, James Journal name Trials Volume number 18 Article ID 165 Start page 1 End page 11 Total pages 11 Publisher BioMed Central Place of publication London, Eng. Publication date 2017 ISSN 1745-6215 Keyword(s) Adjuvant Clinical trial Early Psychosis Intervention PANSS RCT Schizophrenia Sodium benzoate Science & technology Life sciences & biomedicine Medicine, research & experimental Research & experimental medicine Amino-acid oxidase Serine induced nephrotoxicity Placebo controlled trial Drug naive patient Major depression Clinical trials Double blind Inhibitor Brain Summary 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. Language eng DOI 10.1186/s13063-017-1908-5 Field of Research 110399 Clinical Sciences not elsewhere classified 1102 Cardiovascular Medicine And Haematology 1103 Clinical Sciences Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences HERDC Research category C1 Refereed article in a scholarly journal ERA Research output type C Journal article Copyright notice ©2017, The Authors Free to Read? 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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.