title: The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12615000187549 . Registered on 26 February 2015.
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.|University of Queensland Centre for Clinical Research, University of Queensland, Herston, QLD, Australia.
authors.forename: Alex
authors.initials: A
authors.lastname: Ryan
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Baker
authors.affiliation: Metro South Mental Health, 519 Kessels Road, MacGregor, QLD, 4109, Australia.
authors.forename: Frances
authors.initials: F
authors.lastname: Dark
authors.affiliation: Metro South Mental Health, 519 Kessels Road, MacGregor, QLD, 4109, Australia.
authors.forename: Sharon
authors.initials: S
authors.lastname: Foley
authors.affiliation: Metro North Mental Health, Royal Brisbane and Women's Hospital, Level 3 UQCCR, RBWH, Herston, QLD, 4029, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Gordon
authors.affiliation: Logan Hospital, Armstrong Rd and Loganlea Rd, Meadowbrook, QLD, 4131, Australia.
authors.forename: Sean
authors.initials: S
authors.lastname: Hatherill
authors.affiliation: Lady Cilento Children's Hospital, Raymond Terrace, South Brisbane, QLD, 4101, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Stathis
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.|Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.
authors.forename: Sukanta
authors.initials: S
authors.lastname: Saha
authors.affiliation: Metro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, QLD, Australia.
authors.forename: George
authors.initials: G
authors.lastname: Bruxner
authors.affiliation: Specialist Child and Adolescent Psychiatrist, Evolve Therapeutic Services Logan, Child and Youth Mental Health Services Logan, Academic Clinical Unit Logan, Metro South Hospital and Health Services, Logan, QLD, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Beckman
authors.affiliation: Prince Charles Hospital, Chermside, Rode Rd, Chermside, QLD, 4032, Australia.
authors.forename: Drew
authors.initials: D
authors.lastname: Richardson
authors.affiliation: IMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon Health, P.O. Box 291, Geelong, 3220, Australia.|Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, 3052, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.affiliation: IMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon Health, P.O. Box 291, Geelong, 3220, Australia.|Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Level 1 North, Main Block, Parkville, 3052, Australia.
authors.forename: Olivia
authors.initials: O
authors.lastname: Dean
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.|Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.
authors.forename: John
authors.initials: J
authors.lastname: McGrath
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.
authors.forename: Cadence Working
authors.initials: CW
authors.lastname: Group
authors.affiliation: Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia. james.scott@health.qld.gov.au.|University of Queensland Centre for Clinical Research, University of Queensland, Herston, QLD, Australia. james.scott@health.qld.gov.au.|Metro North Mental Health, Royal Brisbane and Women's Hospital, Level 3 UQCCR, RBWH, Herston, QLD, 4029, Australia. james.scott@health.qld.gov.au.
authors.forename: James
authors.initials: J
authors.lastname: Scott
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D011793:Queensland; D012107:Research Design; D020160:Sodium Benzoate / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D015415:Biomarkers; D020160:Sodium Benzoate
keywords: Adjuvant; Clinical trial; Early Psychosis; Intervention; PANSS; RCT; Schizophrenia; Sodium benzoate