The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial.

Title The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial.
Authors A. Ryan; A. Baker; F. Dark; S. Foley; A. Gordon; S. Hatherill; S. Stathis; S. Saha; G. Bruxner; M. Beckman; D. Richardson; M. Berk; O. Dean; J. McGrath; C.Working Group; J. Scott
Journal Trials
DOI 10.1186/s13063-017-1908-5
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.

Citation A. Ryan; A. Baker; F. Dark; S. Foley; A. Gordon; S. Hatherill; S. Stathis; S. Saha; G. Bruxner; M. Beckman; D. Richardson; M. Berk; O. Dean; J. McGrath; C.Working Group; J. Scott.The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial.. Trials. 2017;18(1):165. doi:10.1186/s13063-017-1908-5

Related Elements

Sodium

11 Na 22.989769280 Sodium

Sodium Bohr ModelSee more Sodium products. Sodium (atomic symbol: Na, atomic number: 11) is a Block D, Group 5, Period 4 element with an atomic weight of 22.989769. The number of electrons in each of Sodium's shells is [2, 8, 1] and its electron configuration is [Ne] 3s1. The sodium atom has a radius of 185.8 pm and a Van der Waals radius of 227 pm. Sodium was discovered and first isolated by Sir Humphrey Davy in 1807. In its elemental form, sodium has a silvery-white metallic appearance. It is the sixth most abundant element, making up 2.6 % of the earth's crust. Sodium does not occur in nature as a free element and must be extracted from its compounds (e.g., feldspars, sodalite, and rock salt). The name Sodium is thought to come from the Arabic word suda, meaning "headache" (due to sodium carbonate's headache-alleviating properties), and its elemental symbol Na comes from natrium, its Latin name.

Related Forms & Applications

Benzoates
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