A Phased Clinical Trial of a Dietary Supplement Kava: Biomarker Changes and Anxiolytic Effects Phase 2: Kava Biomarker
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mean PRKACA Change
研究概览
简要总结
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.
详细描述
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava, a natural dietary supplement. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder. Clinical measures of anxiety, blood, and urine will be obtained. Biomarkers of interest include PRKACA, cortisol, urinary TCE, and NA5HT. Participants will be assessed pre- and post-treatment. The participants will also be followed for 12 weeks after the end of treatment to identify any potential rare adverse events, particularly liver toxicity, that appear in a delayed fashion.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 18-50 who meet Diagnostic Statistical Manual (DSM)-5 criteria for GAD as the primary psychiatric diagnosis
- •No more than one failed therapeutic trial of an FDA approved medication for the treatment of GAD
- •Score of>14 on the Hamilton Anxiety Rating Scale at both screening and baseline
- •At least a 4 (moderate) on the Clinical Global Impressions Severity Scale at both screening and baseline
- •Females of potential childbearing status must use adequate contraceptive precautions.
排除标准
- •Unwilling/unable/unsafe to stop psychotropic medications (if on any) for the duration of the study
- •Inability to refrain from acetaminophen, alcohol or other potentially hepatotoxic substances
- •History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries
- •Unstable medical or neurological condition
- •Positive urine drug screen for substances of abuse
- •Active substance abuse/dependence
- •Lifetime history of a psychotic disorder, bipolar disorder, PTSD or Obsessive Compulsive Disorder
- •Any significant risk for self-harm or suicidality as determined by the principal investigator or suicide attempt within the last 6 months
- •Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate
- •Montgomery-Asberg Depression Rating Scale (MADRS) > 17 (moderate or severe depressive symptoms)
研究组 & 干预措施
Kava Pharmacokinetics Group
75 mg kava dietary supplement capsules per day for one week.
干预措施: Kava Dietary Supplement (Drug)
Placebo
Three placebo capsule per day for one week
干预措施: Placebo (Drug)
结局指标
主要结局
Mean PRKACA Change
时间窗: From Baseline (pre dose) to 1 week after taking the first dose (post dose)
The change in mean PRKACA value from pre to post-treatment
次要结局
未报告次要终点