ACTRN12616000859482已完成2 期
The efficacy of adjunctive Garcinia mangostana Linn. (mangosteen) pericarp for the treatment of schizophrenia: A 24-week double blind randomised placebo controlled trial
niversity Hospital-Barwon Health0 个研究点目标入组 150 人开始时间: 2016年6月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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 o limit(—)
- 性别
- All
入选标准
- •1. Being 18 years or older
- •2. Have a DSM-V diagnosis of schizophrenia or schizoaffective disorder.
- •3. Score greater than or equal to 54 on the PANSS total score or have a CGI-S score of greater than or equal to 3.
- •4. Participants currently under therapy for schizophrenia or schizoaffective disorder will need to have been on that primary therapy for at least four weeks prior to randomization.
- •5. Have the capacity to consent to the study and comply with the procedures.
- •6. Be using effective contraception if female, sexually active and childbearing age.
- •7. Be able to speak, read, write and understand English language.
- •8. Participants will be required to nominate a current treating physician and will not be eligible to enter the study until one is identified.
排除标准
- •1. Participants with a known or suspected active systemic medical disorder.
- •2. Individuals who are pregnant or lactating.
- •3. Participants currently enrolled in any other intervention study.
- •4. Individuals who are intolerant, allergic to or have had an anaphylactic reaction to any of the components of the preparation.
- •5. Inability to comply with either the requirements of informed consent or treatment protocol.
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