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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

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus

Schedule of visits and assessments. GAF Global Assessment of Functioning, AQOL Assessment of Quality of Life, APQ Activity and Participation Questionnaire, CGI Clinical Global Impression, HDRS Hamilton Depression Rating Scale, OTI Opiate Treatment Index, PGI-I Patients’ Global Impression of Improvement
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Fig1: Schedule of visits and assessments. GAF Global Assessment of Functioning, AQOL Assessment of Quality of Life, APQ Activity and Participation Questionnaire, CGI Clinical Global Impression, HDRS Hamilton Depression Rating Scale, OTI Opiate Treatment Index, PGI-I Patients’ Global Impression of Improvement

Mentions: Participants will be clinically assessed at baseline and weeks 2, 4, 6, 8, 10 and 12. The study team will also contact participants once a week in between one-to-one assessments by telephone (if no telephone then by face-to-face review). Detailed schedule of visits and assessments are presented in Fig. 1. This protocol was written following the SPIRIT checklist.Fig. 1


The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial
Schedule of visits and assessments. GAF Global Assessment of Functioning, AQOL Assessment of Quality of Life, APQ Activity and Participation Questionnaire, CGI Clinical Global Impression, HDRS Hamilton Depression Rating Scale, OTI Opiate Treatment Index, PGI-I Patients’ Global Impression of Improvement
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5383965&req=5

Fig1: Schedule of visits and assessments. GAF Global Assessment of Functioning, AQOL Assessment of Quality of Life, APQ Activity and Participation Questionnaire, CGI Clinical Global Impression, HDRS Hamilton Depression Rating Scale, OTI Opiate Treatment Index, PGI-I Patients’ Global Impression of Improvement
Mentions: Participants will be clinically assessed at baseline and weeks 2, 4, 6, 8, 10 and 12. The study team will also contact participants once a week in between one-to-one assessments by telephone (if no telephone then by face-to-face review). Detailed schedule of visits and assessments are presented in Fig. 1. This protocol was written following the SPIRIT checklist.Fig. 1

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus