ACTRN12621000327886招募中2 期
Dose finding clinical trial of sodium benzoate in people with treatment refractory schizophrenia
QIMR Berghofer Medical Institute of Research0 个研究点目标入组 52 人开始时间: 2021年3月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •1.Aged between 18 and 64 years (inclusive).
- •2.Fulfil the DSM-IV criteria practice for schizophrenia, based on the Diagnostic Interview for Psychosis.
- •3.Have had the diagnosis of schizophrenia for at least 12 months duration
- •4.Have a Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70
- •5.Have received antipsychotic medications for a period of at least one continuous month prior to assessment for the study and remained symptomatic despite taking antipsychotic therapy
- •6.Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
排除标准
- •1.Known allergies to sodium benzoate (E211) or any part of the formulation of the
- •investigational product.
- •2.Suspected allergies or known adverse reactions to food preservatives in general.
- •3.Comorbid physical illnesses that would impair the participants’ ability to complete the trial.
- •4.People who are unable to understand or communicate in English.
- •5.For female participant, those currently pregnant, or planning to become pregnant or lactating during the study period.
- •6.Inability to follow the study instructions and procedures.
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