ACTRN12610000381088已完成3 期
Examining the effects of administration of Kava on anxiety versus placebo in adults aged 18-65 presenting with Generalized Anxiety Disorder (GAD).
Integria0 个研究点目标入组 160 人开始时间: 2010年5月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
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 65 Years(—)
- 性别
- All
入选标准
- •Any person aged 18-65 presenting with a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Structured Clinical Interview for DSM (SCID) diagnosed GAD, and a HAM-A of >14.
排除标准
- •Primary diagnosis other than GAD; Psychotic or Bipolar illness; Significant suicidal ideation in the previous 6 months; antidepressant, mood stabiliser, antipsychotic, opiod analgesics, St John’s wort, Human immunodeficiency virus (HIV), anti-tumoral/cancer, blood pressure, warfarin, Parkinson’s, epileptic, migraine or anti-ulcer medication; Diagnosed hepato-biliary disease/inflammation (or elevated liver enzymes at Baseline blood test); Thyroid disease (or thyroid hormone abnormality at baseline blood test); DSM-IV diagnosed substance abuse or dependency disorder including alcohol in the previous 6 months; Regular use of Kava in the previous 12 months; Previous adverse reaction to Kava; Seeing a psychologist or counsellor currently or in the previous month; Pregnancy or trying to conceive; Lack of facility in written or spoken English; Montgomery-Asberg Depression Rating Scale (MADRS) score of >18.
研究者
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