NCT02219880

Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.

Detailed description

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kava (240mg of kavalactones per day)	Kava 60 milligrams per tablet = 240mg of kavalactones per day
DIETARY_SUPPLEMENT	Placebo	Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.

Timeline

• Start date: 2015-10-13
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2014-08-19
• Last updated: 2018-10-15

Locations

2 sites across 1 country: Australia