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
- 2
- 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
- •To be considered for inclusion in this study, participants will be required to meet the following criteria:
- •Aged between 18-70 years
- •Meets the Diagnostic and Statistical Manual (DSM) IV and DSM-V diagnostic criteria for generalised anxiety disorder (GAD) based on structured interview (Mini International Neuropsychiatric Interview-Plus 6 [MINI-Plus 6]. Note that while the MINI-Plus 6 uses the DSM-IV criteria, the same criteria are used in the DSM-V).
- •Presents with anxiety (Hamilton Anxiety Rating Scale ≥ 18) at the time of study entry
- •Fluent in written and spoken English
- •Provides a signed copy of the consent form
- •Participants are ineligible to enter the trial if they have any of the following conditions:
- •Primary diagnosis other than GAD
- •Presentation of moderate to severe depressive symptoms (Montgomery-Asberg Rating Scale: MADRS ≥ 18 at time of study entry or ≥ 24 at any time during study)
- •Presentation of suicidal ideation (≥ 3 on MADRS suicidal thoughts domain at time of study entry or at any time during study)
- •Current diagnosis of bipolar disorder or schizophrenia on structured interview (MINI Plus)
- •Current substance/alcohol use disorder on structured interview (MINI Plus) Page 21 of 39 Commercial-in-Confidence
- •Currently taking an antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin or thyroxin, or current regular use (more than 2 days per week) of a benzodiazepine or opioid-based analgesic
- •Current use of a psychotropic nutraceutical (e.g. St John's wort)
- •Previous intolerance to kava
- •Three or more failed trials of pharmacotherapy for the current GAD episode
- •Recently commenced psychotherapy (within four weeks of study entry)
- •Known or suspected clinically unstable systemic medical disorder
- •Diagnosed hepato-biliary disease/inflammation
- •Elevated liver enzymes at baseline blood test
- •Pregnancy or breastfeeding, or trying to conceive
- •Not using medically approved contraception (including abstinence) if female and of childbearing age
- •Unable to participate in all scheduled visits, treatment plan, or other trial procedures according to the protocol (except for the optional genetic component)
排除标准
- 未提供
研究组 & 干预措施
Placebo
Inert tablets matched for colour, size and consistency to active arm treatment. Both treatment arm tablets will match in appearance, and neither participants nor the trial clinicians will know what they are taking.
干预措施: Placebo (Dietary Supplement)
Kava - standardised 240mg kavalactones
Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day
干预措施: Kava (240mg of kavalactones per day) (Dietary Supplement)
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