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The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial
- Source :
- Trials, Trials, Vol 18, Iss 1, Pp 1-11 (2017)
- Publication Year :
- 2017
- Publisher :
- BioMed Central, 2017.
-
Abstract
- 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1908-5) contains supplementary material, which is available to authorized users.
- Subjects :
- PANSS
Male
Time Factors
Placebo-controlled study
Medicine (miscellaneous)
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Quality of life
Clinical Protocols
law
Sodium Benzoate
Surveys and Questionnaires
Medicine
Pharmacology (medical)
030212 general & internal medicine
Adjuvant
education.field_of_study
lcsh:R5-920
Positive and Negative Syndrome Scale
Middle Aged
3. Good health
Clinical trial
Mental Health
Treatment Outcome
Patient Satisfaction
Research Design
Female
Queensland
lcsh:Medicine (General)
RCT
Antipsychotic Agents
Adult
medicine.medical_specialty
Adolescent
Early Psychosis
Population
Intervention
03 medical and health sciences
Young Adult
Double-Blind Method
Humans
Psychiatry
education
Psychiatric Status Rating Scales
business.industry
Psychotic Disorders
Adjunctive treatment
Clinical Global Impression
Schizophrenia
Quality of Life
business
030217 neurology & neurosurgery
Biomarkers
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....686450c4ff4c7cce60e5a436df48a958