TY - JOUR
T1 - The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ
T2 - Study protocol for a randomized controlled trial
AU - Ryan, Alex
AU - Baker, Andrea
AU - Dark, Frances
AU - Foley, Sharon
AU - Gordon, Anne
AU - Hatherill, Sean
AU - Stathis, Stephen
AU - Saha, Sukanta
AU - Bruxner, George
AU - Beckman, Martin
AU - Richardson, Drew
AU - Berk, Michael
AU - Dean, Olivia
AU - McGrath, John
AU - Scott, James
AU - Cadence Working Group
PY - 2017/4/7
Y1 - 2017/4/7
N2 - 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.
AB - 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.
KW - Adjuvant
KW - Clinical trial
KW - Early psychosis
KW - Intervention
KW - PANSS
KW - RCT
KW - Schizophrenia
KW - Sodium benzoate
UR - http://www.scopus.com/inward/record.url?scp=85018646569&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-1908-5
DO - 10.1186/s13063-017-1908-5
M3 - Article
AN - SCOPUS:85018646569
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
M1 - 165
ER -
