PMID- 28388932
OWN - NLM
STAT- MEDLINE
DCOM- 20180226
LR  - 20181113
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 18
IP  - 1
DP  - 2017 Apr 7
TI  - The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - 
      CADENCE-BZ: study protocol for a randomized controlled trial.
PG  - 165
LID - 10.1186/s13063-017-1908-5 [doi]
LID - 165
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 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. TRIAL REGISTRATION: Australian New Zealand 
      Clinical Trials registry (ANZCTR), ACTRN12615000187549 . Registered on 26 
      February 2015.
FAU - Ryan, Alex
AU  - Ryan A
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia.
AD  - University of Queensland Centre for Clinical Research, University of Queensland, 
      Herston, QLD, Australia.
FAU - Baker, Andrea
AU  - Baker A
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia.
FAU - Dark, Frances
AU  - Dark F
AD  - Metro South Mental Health, 519 Kessels Road, MacGregor, QLD, 4109, Australia.
FAU - Foley, Sharon
AU  - Foley S
AD  - Metro South Mental Health, 519 Kessels Road, MacGregor, QLD, 4109, Australia.
FAU - Gordon, Anne
AU  - Gordon A
AD  - Metro North Mental Health, Royal Brisbane and Women's Hospital, Level 3 UQCCR, 
      RBWH, Herston, QLD, 4029, Australia.
FAU - Hatherill, Sean
AU  - Hatherill S
AD  - Logan Hospital, Armstrong Rd and Loganlea Rd, Meadowbrook, QLD, 4131, Australia.
FAU - Stathis, Stephen
AU  - Stathis S
AD  - Lady Cilento Children's Hospital, Raymond Terrace, South Brisbane, QLD, 4101, 
      Australia.
FAU - Saha, Sukanta
AU  - Saha S
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia.
AD  - Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.
FAU - Bruxner, George
AU  - Bruxner G
AD  - Metro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, QLD, 
      Australia.
FAU - Beckman, Martin
AU  - Beckman M
AD  - 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.
FAU - Richardson, Drew
AU  - Richardson D
AD  - Prince Charles Hospital, Chermside, Rode Rd, Chermside, QLD, 4032, Australia.
FAU - Berk, Michael
AU  - Berk M
AD  - IMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon 
      Health, P.O. Box 291, Geelong, 3220, Australia.
AD  - Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, 
      Level 1 North, Main Block, Parkville, 3052, Australia.
FAU - Dean, Olivia
AU  - Dean O
AD  - IMPACT Strategic Research Centre, Deakin University, School of Medicine, Barwon 
      Health, P.O. Box 291, Geelong, 3220, Australia.
AD  - Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, 
      Level 1 North, Main Block, Parkville, 3052, Australia.
FAU - McGrath, John
AU  - McGrath J
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia.
AD  - Queensland Brain Institute, University of Queensland, St Lucia, QLD, Australia.
FAU - Group, Cadence Working
AU  - Group CW
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia.
FAU - Scott, James
AU  - Scott J
AD  - Queensland Centre for Mental Health Research, The Park Centre for Mental Health, 
      Wacol, QLD, Australia. james.scott@health.qld.gov.au.
AD  - University of Queensland Centre for Clinical Research, University of Queensland, 
      Herston, QLD, Australia. james.scott@health.qld.gov.au.
AD  - Metro North Mental Health, Royal Brisbane and Women's Hospital, Level 3 UQCCR, 
      RBWH, Herston, QLD, 4029, Australia. james.scott@health.qld.gov.au.
LA  - eng
SI  - ANZCTR/ACTRN12615000187549
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170407
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Biomarkers)
RN  - OJ245FE5EU (Sodium Benzoate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Biomarkers/blood
MH  - Clinical Protocols
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mental Health
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Psychiatric Status Rating Scales
MH  - Psychotic Disorders/diagnosis/*drug therapy/psychology
MH  - Quality of Life
MH  - Queensland
MH  - Research Design
MH  - Sodium Benzoate/adverse effects/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5383965
OTO - NOTNLM
OT  - Adjuvant
OT  - Clinical trial
OT  - Early Psychosis
OT  - Intervention
OT  - PANSS
OT  - RCT
OT  - Schizophrenia
OT  - Sodium benzoate
EDAT- 2017/04/09 06:00
MHDA- 2018/02/27 06:00
PMCR- 2017/04/07
CRDT- 2017/04/09 06:00
PHST- 2016/11/30 00:00 [received]
PHST- 2017/03/16 00:00 [accepted]
PHST- 2017/04/09 06:00 [entrez]
PHST- 2017/04/09 06:00 [pubmed]
PHST- 2018/02/27 06:00 [medline]
PHST- 2017/04/07 00:00 [pmc-release]
AID - 10.1186/s13063-017-1908-5 [pii]
AID - 1908 [pii]
AID - 10.1186/s13063-017-1908-5 [doi]
PST - epublish
SO  - Trials. 2017 Apr 7;18(1):165. doi: 10.1186/s13063-017-1908-5.