Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 4
- 主要终点
- Hamilton Anxiety Rating Scale (HAMA) - change in score
研究概览
简要总结
The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.
详细描述
The primary aim is to confirm the efficacy and safety of Kava compared to placebo in Generalized Anxiety Disorder (GAD). Secondary aims of the study are to confirm the relationship between specific genetic variations and response to Kava, and to explore the effects of Kava on the expression of specific genes.
Consenting participants will be randomly allocated to take either Kava or placebo over 18 weeks. They will be assessed at regular interviews throughout the trial and will have four blood tests (liver function tests to monitor participant safety, and collection of genetic material providing information on neurochemistry). The design of the study is a multi-centre, 18-week, 2-arm, double-blind randomised clinical trial (RCT) using a standardised pharmaceutical-grade water-soluble extract of Kava (240mg of kavalactones per day) versus placebo in 210 adults with GAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAMA) - change in score
时间窗: 18 weeks
Reduction of participant's anxiety will be assessed on the HAMA from baseline to week 16 across time used a mixed methods model.
次要结局
- Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention(18 weeks)
研究者
Jerome Sarris
Dr Jerome Sarris
University of Melbourne