Generalized Anxiety Disorder Clinical Trial
Official title:
Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.
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.
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