You are not logged in.
Openly accessible

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 12

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, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Dean, OliviaORCID iD for 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? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30095892

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
Connect to link resolver
 
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.

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.

Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 0 times in TR Web of Science
Scopus Citation Count Cited 0 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 28 Abstract Views, 14 File Downloads  -  Detailed Statistics
Created: Thu, 11 May 2017, 15:21:08 EST

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.