Ryan Alex, Baker Andrea, Dark Frances, Foley Sharon, Gordon Anne, Hatherill Sean, Stathis Stephen, Saha Sukanta, Bruxner George, Beckman Martin, Richardson Drew, Berk Michael, Dean Olivia, McGrath John, Group Cadence Working, Scott James
Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, Australia.
University of Queensland Centre for Clinical Research, University of Queensland, Herston, QLD, Australia.
Trials. 2017 Apr 7;18(1):165. doi: 10.1186/s13063-017-1908-5.
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.
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.
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.
Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12615000187549 . Registered on 26 February 2015.
精神病性障碍影响着高达3%的人口，且往往是慢性的、使人致残的。近几十年来，精神病药理学治疗方面的创新一直停滞不前。为了改善精神病患者的治疗效果，我们提出一项关于一种常见食品防腐剂苯甲酸钠作为早期精神病辅助治疗的试验方案。
将通过澳大利亚昆士兰州的医院和社区心理健康服务机构招募早期精神病患者（n = 160）。患者将被随机分配接受为期12周的1000毫克（每日两次，每次500毫克）苯甲酸钠治疗或安慰剂治疗。除了每周进行的同意能力、药物依从性和安全性评估外，患者还将每两周进行一次结果评估。主要结局指标是阳性与阴性症状量表（PANSS）总分。次要结局指标包括功能总体评定量表（GAF）、生活质量评估量表（AQOL）、活动与参与问卷（APQ6）、国际体力活动问卷（IPAQ）、简单体力活动问卷（SIMPAQ）、体力活动问卷、临床总体印象量表（CGI）、汉密尔顿抑郁量表17项版（HDRS）、阿片治疗指数（OTI）以及患者总体改善印象量表（PGI - I）。作为第三项目标，将研究从基线到终点与D - 丙氨酸、L - 丙氨酸、D - 丝氨酸、L - 丝氨酸、甘氨酸和谷氨酸相关的血清标志物的变化。
消费者和临床医生都渴望帮助开发针对精神病患者的更好治疗方法。这项研究作为更广泛的节奏临床试验平台的一部分，将检验一种安全且易于获取的食品防腐剂是否有助于优化精神病患者的治疗效果。
澳大利亚新西兰临床试验注册中心（ANZCTR），ACTRN12615000187549。于2015年2月26日注册。
