Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Dietary Supplement: Kava (240mg of kavalactones per day)Dietary Supplement: Placebo
- Registration Number
- NCT02219880
- Lead Sponsor
- University of Melbourne
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kava - standardised 240mg kavalactones Kava (240mg of kavalactones per day) Standardised 240mg kavalactones per day - fixed dose regime of two tablets of kava twice per day Placebo 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.
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Rating Scale (HAMA) - change in score 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.
- Secondary Outcome Measures
Name Time Method Gamma-aminobutyric acid (GABA) transporter polymorphisms moderating response to study intervention 18 weeks Will assess whether response to Kava will be moderated by gamma-aminobutyric acid (GABA) transporter polymorphisms. Specifically, whether rs2601126-T allele or rs2697153-A allele carriers have greater reduction of anxiety
Trial Locations
- Locations (2)
Royal Brisbane & Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Centre for Human Psychopharmacology - Swinburne University
🇦🇺Melbourne, Victoria, Australia