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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: Study protocol for a randomized controlled trial
Trials, Volume 18, No. 1, Article 165, Year 2017
Notification
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Description
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. Registered on 26 February 2015. © 2017 The Author(s).
Authors & Co-Authors
Hatherill, Sean
Unknown Affiliation
Saha, Sukanta
Australia, Wacol
Park Centre for Mental Health
Australia, Brisbane
The University of Queensland
Berk, Michael
Australia, Geelong
Barwon Health
Australia, Melbourne
Royal Melbourne Hospital
Dean, Olívia May
Australia, Geelong
Barwon Health
Australia, Melbourne
Royal Melbourne Hospital
McGrath, John Joseph
Australia, Wacol
Park Centre for Mental Health
Australia, Brisbane
The University of Queensland
Scott, James Graham
Australia, Wacol
Park Centre for Mental Health
Australia, Brisbane
The University of Queensland
Australia, Brisbane
Royal Brisbane and Women's Hospital
Statistics
Citations: 12
Authors: 6
Affiliations: 8
Identifiers
Doi:
10.1186/s13063-017-1908-5
ISSN:
17456215
Research Areas
Disability
Food Security
Mental Health
Study Design
Cross Sectional Study
Study Approach
Quantitative